DreaMS · MSFrontier

Stopped earlyPhase 2Relapsing MSNCT01226745 2010-018705-11

What it found

Stopped: not working

The trial was stopped early because the treatment was not working.

Reason given: Merck has decided to not pursue phase 3 development of ceralifimod (ONO-4641). The decision was not related to any safety and efficacy findings

What was tested

Treatment tested

ONO-4641
ONO-4641/MSC2430913A

Results by group

Number of Subjects With Clinically Significant Abnormal Vital Signs

Baseline up to Week 255

Group	Value	Number analysed
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)

Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255

Group	Value	Interval	Number analysed
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.227 Percentage of predicted value	6.5379 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-0.741 Percentage of predicted value	6.2026 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-0.062 Percentage of predicted value	5.4947 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.500 Percentage of predicted value	5.0115 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.555 Percentage of predicted value	7.8424 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-1.146 Percentage of predicted value	4.7952 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.675 Percentage of predicted value	7.7166 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.981 Percentage of predicted value	6.8499 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-0.484 Percentage of predicted value	6.0952 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-3.113 Percentage of predicted value	5.4753 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-2.851 Percentage of predicted value	6.7997 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.561 Percentage of predicted value	5.504 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	1.148 Percentage of predicted value	9.595 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.352 Percentage of predicted value	6.1152 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.650 Percentage of predicted value	7.2084 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.574 Percentage of predicted value	6.3645 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-2.300 Percentage of predicted value	9.2869 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	2.657 Percentage of predicted value	8.928 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.746 Percentage of predicted value	8.3955 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.790 Percentage of predicted value	8.2129 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-1.187 Percentage of predicted value	7.8818 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-3.202 Percentage of predicted value	6.7073 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-3.748 Percentage of predicted value	8.5817 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-1.207 Percentage of predicted value	7.74 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.795 Percentage of predicted value	9.6531 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.003 Percentage of predicted value	7.7998 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.197 Percentage of predicted value	7.9068 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.178 Percentage of predicted value	9.7656 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.968 Percentage of predicted value	9.2415 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.874 Percentage of predicted value	8.2237 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-1.828 Percentage of predicted value	10.8131 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-3.429 Percentage of predicted value	8.4036 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-1.234 Percentage of predicted value	6.527 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-0.459 Percentage of predicted value	9.0302 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-3.052 Percentage of predicted value	9.497 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-2.599 Percentage of predicted value	10.3997 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-6.803 Percentage of predicted value	6.7393 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	0.443 Percentage of predicted value	6.084 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-1.780 Percentage of predicted value	11.6068 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.984 Percentage of predicted value	13.8177 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-4.109 Percentage of predicted value	21.4354 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	2.108 Percentage of predicted value	8.1682 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-3.786 Percentage of predicted value	7.3297 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	4.515 Percentage of predicted value	11.3809 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-1.725 Percentage of predicted value	7.4166 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-11.929 Percentage of predicted value	13.1156 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-11.525 Percentage of predicted value	12.3316 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	2.688 Percentage of predicted value	5.5468 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.024 Percentage of predicted value	8.0705 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-0.354 Percentage of predicted value	12.8489 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-2.144 Percentage of predicted value	8.3421 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.299 Percentage of predicted value	8.2038 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-4.557 Percentage of predicted value	13.3731 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	0.944 Percentage of predicted value	7.8955 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-1.416 Percentage of predicted value	9.4274 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.031 Percentage of predicted value	10.6185 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-2.859 Percentage of predicted value	9.6661 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.321 Percentage of predicted value	8.7759 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.291 Percentage of predicted value	10.4528 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-3.249 Percentage of predicted value	11.5213 (Standard Deviation)	29
ONO-4641 0.15 Milligram (mg) - 0.15 mg	-0.368 Percentage of predicted value	13.5515 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.374 Percentage of predicted value	11.092 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-0.027 Percentage of predicted value	13.0574 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-0.209 Percentage of predicted value	12.1999 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-2.377 Percentage of predicted value	11.6511 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.963 Percentage of predicted value	14.2975 (Standard Deviation)	29

Change From Baseline in Forced Vital Capacity (FVC)

Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255

Group	Value	Interval	Number analysed
ONO-4641 0.15 mg - 0.15 mg	-0.123 Percentage of predicted value	6.9868 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.000 Percentage of predicted value	6.406 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.921 Percentage of predicted value	6.9931 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.593 Percentage of predicted value	5.052 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	1.554 Percentage of predicted value	7.9727 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.423 Percentage of predicted value	5.5244 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.681 Percentage of predicted value	6.1396 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.175 Percentage of predicted value	6.1523 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.107 Percentage of predicted value	7.7364 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.690 Percentage of predicted value	5.2847 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-0.111 Percentage of predicted value	6.2548 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-1.442 Percentage of predicted value	6.8125 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	1.397 Percentage of predicted value	8.1634 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.906 Percentage of predicted value	6.0432 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	1.828 Percentage of predicted value	10.0612 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.487 Percentage of predicted value	6.583 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	0.568 Percentage of predicted value	6.453 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.707 Percentage of predicted value	11.3657 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.308 Percentage of predicted value	7.9759 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.433 Percentage of predicted value	6.678 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.118 Percentage of predicted value	7.8025 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.683 Percentage of predicted value	4.987 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.623 Percentage of predicted value	8.3312 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-2.927 Percentage of predicted value	7.867 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.794 Percentage of predicted value	7.8392 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.246 Percentage of predicted value	6.5967 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.890 Percentage of predicted value	7.8545 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.582 Percentage of predicted value	8.464 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-0.487 Percentage of predicted value	8.2776 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-1.821 Percentage of predicted value	7.7421 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.909 Percentage of predicted value	6.7009 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-3.078 Percentage of predicted value	6.6149 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.124 Percentage of predicted value	7.7589 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-2.010 Percentage of predicted value	7.8162 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-0.715 Percentage of predicted value	6.7088 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-4.803 Percentage of predicted value	9.3143 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-4.225 Percentage of predicted value	8.2667 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-0.632 Percentage of predicted value	5.1482 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	979.704 Percentage of predicted value	3533.9625 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	0.278 Percentage of predicted value	9.2002 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	0.459 Percentage of predicted value	16.2506 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	2.813 Percentage of predicted value	6.3216 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-4.256 Percentage of predicted value	7.4403 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-0.074 Percentage of predicted value	6.8982 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-2.829 Percentage of predicted value	7.0313 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-3.748 Percentage of predicted value	9.0311 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-2.726 Percentage of predicted value	17.6042 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-1.283 Percentage of predicted value	9.759 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.316 Percentage of predicted value	5.0212 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-3.057 Percentage of predicted value	12.0551 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-1.590 Percentage of predicted value	8.9426 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.109 Percentage of predicted value	5.4668 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.152 Percentage of predicted value	14.6922 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	4.287 Percentage of predicted value	8.1537 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.033 Percentage of predicted value	6.5169 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.952 Percentage of predicted value	9.6157 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-0.903 Percentage of predicted value	10.0341 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-1.593 Percentage of predicted value	8.6842 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-0.892 Percentage of predicted value	5.6941 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-4.731 Percentage of predicted value	12.9422 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-0.717 Percentage of predicted value	8.1437 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.686 Percentage of predicted value	10.456 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	1.386 Percentage of predicted value	13.997 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-0.115 Percentage of predicted value	13.4126 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-1.059 Percentage of predicted value	10.2246 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	-0.675 Percentage of predicted value	11.1022 (Standard Deviation)	29

Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)

Baseline, Week 40, 52, early termination, Week 152, 200, 255

Group	Value	Interval	Number analysed
ONO-4641 0.15 mg - 0.15 mg	2.4 Percentage of predicted value	13.16 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-1.0 Percentage of predicted value	10.98 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	-2.4 Percentage of predicted value	17.36 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-5.3 Percentage of predicted value	16.02 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-2.7 Percentage of predicted value	10.61 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	3.3 Percentage of predicted value	6.4 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-3.7 Percentage of predicted value	8.36 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-2.7 Percentage of predicted value	10.74 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	0.8 Percentage of predicted value	20.01 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-5.3 Percentage of predicted value	11.56 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	-4.8 Percentage of predicted value	8.04 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	5.2 Percentage of predicted value	6.34 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	-6.5 Percentage of predicted value	2.12 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	-9.0 Percentage of predicted value		87
ONO-4641 0.05 mg - 0.05 mg	-43.0 Percentage of predicted value	46.67 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-16.3 Percentage of predicted value	12.58 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	Not reached		26
Placebo - ONO4641 0.05 mg	Not reached		29
ONO-4641 0.15 mg - 0.15 mg	-1.0 Percentage of predicted value	1 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	11.0 Percentage of predicted value		87
ONO-4641 0.05 mg - 0.05 mg	9.5 Percentage of predicted value	3.54 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	-14.0 Percentage of predicted value		29
Placebo - ONO4641 0.10 mg	Not reached		26
Placebo - ONO4641 0.05 mg	Not reached		29
ONO-4641 0.15 mg - 0.15 mg	3.0 Percentage of predicted value	43.89 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	2.0 Percentage of predicted value	12.85 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	35.8 Percentage of predicted value	34.87 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	9.5 Percentage of predicted value	28.99 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	25.0 Percentage of predicted value	12 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	5.0 Percentage of predicted value	9.9 (Standard Deviation)	29
ONO-4641 0.15 mg - 0.15 mg	42.3 Percentage of predicted value	40.41 (Standard Deviation)	80
ONO-4641 0.10 mg - 0.10 mg	21.0 Percentage of predicted value	29.4 (Standard Deviation)	87
ONO-4641 0.05 mg - 0.05 mg	27.8 Percentage of predicted value	37.38 (Standard Deviation)	89
Placebo - ONO4641 0.15 mg	5.8 Percentage of predicted value	32.79 (Standard Deviation)	29
Placebo - ONO4641 0.10 mg	37.5 Percentage of predicted value	40.78 (Standard Deviation)	26
Placebo - ONO4641 0.05 mg	16.3 Percentage of predicted value	19.52 (Standard Deviation)	29

Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures

Baseline up to Week 255

Group	Value	Number analysed
ONO-4641 0.15 mg - 0.15 mg	4 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	2 Subjects	29

Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination

Baseline up to Week 255

Group	Value	Number analysed
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	4 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	4 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	5 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	4 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	4 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	5 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	5 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	3 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	4 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	4 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	4 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	4 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	4 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	4 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29

Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination

Baseline up to end of the treatment, assessed up to Week 255

Group	Value	Number analysed
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	4 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	4 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	4 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	3 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	5 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	2 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	6 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	7 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	2 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	3 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	5 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	2 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	2 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	0 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	2 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	1 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	1 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	1 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	1 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	0 Subjects	29

Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation

From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years

Group	Value	Number analysed
ONO-4641 0.15 mg - 0.15 mg	75 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	85 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	82 Subjects	89
Placebo - ONO4641 0.15 mg	27 Subjects	29
Placebo - ONO4641 0.10 mg	22 Subjects	26
Placebo - ONO4641 0.05 mg	29 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	16 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	12 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	21 Subjects	89
Placebo - ONO4641 0.15 mg	5 Subjects	29
Placebo - ONO4641 0.10 mg	9 Subjects	26
Placebo - ONO4641 0.05 mg	11 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	1 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	0 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	0 Subjects	89
Placebo - ONO4641 0.15 mg	0 Subjects	29
Placebo - ONO4641 0.10 mg	0 Subjects	26
Placebo - ONO4641 0.05 mg	1 Subjects	29
ONO-4641 0.15 mg - 0.15 mg	6 Subjects	80
ONO-4641 0.10 mg - 0.10 mg	6 Subjects	87
ONO-4641 0.05 mg - 0.05 mg	7 Subjects	89
Placebo - ONO4641 0.15 mg	3 Subjects	29
Placebo - ONO4641 0.10 mg	2 Subjects	26
Placebo - ONO4641 0.05 mg	6 Subjects	29

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
ONO-4641 0.15 Milligram (mg) - 0.15 mg	80	16 (20.0%)
ONO-4641 0.10 mg - 0.10 mg	87	12 (13.8%)
ONO-4641 0.05 mg - 0.05 mg	89	21 (23.6%)
Placebo - ONO4641 0.15 mg	29	5 (17.2%)
Placebo - ONO4641 0.10 mg	26	9 (34.6%)
Placebo - ONO4641 0.05 mg	29	11 (37.9%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Number of Subjects With Clinically Significant Abnormal Vital Signs
Baseline up to Week 255
Safety
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Change From Baseline in Forced Vital Capacity (FVC)
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
Baseline, Week 40, 52, early termination, Week 152, 200, 255
Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures
Baseline up to Week 255
Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination
Baseline up to Week 255
Retina scans (OCT)Vision
Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination
Baseline up to end of the treatment, assessed up to Week 255
MRI lesionsThinking and memory
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years
Safety
The number of Gd-enhanced lesions, lesion volume, and brain volume obtained by MRI at Weeks 40, 52, 100, and 148 will be compared with that of the baseline of the Extension Study
MRI lesionsBrain volume loss

Other measures (4)

Number of Gadolinium (Gd)-Enhanced Lesions
Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)
MRI lesions
Change From Baseline in Lesion Volume at the End of the Treatment (EoT)
Baseline, End of treatment (5 years)
MRI lesions
Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment
Baseline and at end of treatment (Week 255)
MRI lesionsBrain volume loss
N/A

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Completed 26 weeks of double-blind phase of Study ONO-4641POU006 Exclusion Criteria: * Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).

Papers

Loading reviews and guidelines…

Linked trials

Extension of
DreaMS
Phase 2 · Completed

Links found where a registry record names another trial's registry number.

Related trials

VOYAGE
Phase 3 · Not yet recruiting
Still running
TG1101-RMS-PED304
Phase 2 / Phase 3 · Recruiting
Still running
IM047-050
Phase 3 · Recruiting
Still running
COAST
Phase 4 · Recruiting
Still running
Assessing the Cognitive Benefits of Ozanimod and Their Br…
Phase 4 · Withdrawn
Stopped early
A Study to Assess the Effectiveness and Safety of Ozanimo…
Phase 4 · Running, not recruiting
Still running

History

Started
Oct 2010
Main results due
Jan 2015
Finished
Jan 2015
Results posted
Jul 2016

Assembled by software from public sources and not checked by people. Each record links to its source. Report an error