A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168)
A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)
What it found
The trial was stopped early because the treatment was not working.
Reason given: This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.
What was tested
Treatment tested
- PF-06342674 0.25 mg/kg
- PF-06342674 1.5 mg/kg
- PF-06342674 6.0 mg/kg
Placebo
- Placebo
Results by group
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Baseline through Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 3 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 |
Number of Treatment-Emergent AEs and SAEs by Severity
Baseline through Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0 adverse events | 1 | |
| PF-06342674 0.25 mg/kg | 7 adverse events | 3 | |
| Placebo | 0 adverse events | 1 | |
| PF-06342674 0.25 mg/kg | 0 adverse events | 3 | |
| Placebo | 0 adverse events | 1 | |
| PF-06342674 0.25 mg/kg | 0 adverse events | 3 |
Number of Participants With Clinical Laboratory Abnormalities
Baseline through Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 3 participants | 3 |
Placebo
PF-06342674 0.25 mg/kg
Number of Participants With Clinically Significant Changes in Vital Signs
Baseline through Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 |
Number of Participants With Abnormal Electrocardiogram (ECG)
Baseline through Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 1 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 1 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 | |
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 0 participants | 3 |
Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0 participants | 1 | |
| PF-06342674 0.25 mg/kg | 3 participants | 3 |
Placebo
PF-06342674 0.25 mg/kg
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 1 | 0 (0.0%) | |
| PF-06342674 | 3 | 0 (0.0%) |
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 Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Baseline through Day 127/Early Termination
SafetyNumber of Treatment-Emergent AEs and SAEs by Severity
Baseline through Day 127/Early Termination
SafetyNumber of Participants With Clinical Laboratory Abnormalities
Baseline through Day 127/Early Termination
Immune responseSafetyNumber of Participants With Clinically Significant Changes in Vital Signs
Baseline through Day 127/Early Termination
SafetyNumber of Participants With Abnormal Electrocardiogram (ECG)
Baseline through Day 127/Early Termination
Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
Immune response
Other measures (1)
Concentration of PF-06342674
Baseline through Day 127/Early Termination
Who could take part
MS (type not specified) · 18 to 55 · EDSS 0 to 5
Show the full criteria
Inclusion criteria
* Women and men aged 18-55 yrs. * Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria. * Expanded Disability Status Scale (EDSS) between 0-5, inclusive.
Exclusion criteria
* Relapse episode of MS within 2 weeks of enrollment. * Primary progressive MS without a relapsing component. * Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.
Papers
Results
Anti-IL-7 receptor α monoclonal antibody (GSK2618960) in healthy subjects - a randomized, double-blind, placebo-controlled study.Br J Clin Pharmacol · 2019
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History
Started
Sept 2014
Main results due
Oct 2015
Finished
Oct 2015
Results posted
Jan 2017