MSFrontier

A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
CompletedPhase 2Relapsing MSNCT008829992008-007459-28

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Tabalumab

    Tumor necrosis factor ligand superfamily member 13B inhibitor

Placebo or sham

  • Placebo

Results by group

Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24

Weeks 12, 16, 20, and 24

GroupValueIntervalNumber analysed
4 mg LY2127399 Q4W1.819 lesions per scan3.312 (Standard Deviation)34
12 mg LY2127399 Q4W0.710 lesions per scan1.103 (Standard Deviation)31
40 mg LY2127399 Q4W1.237 lesions per scan1.999 (Standard Deviation)31
120 mg LY2127399 Q4W1.477 lesions per scan2.834 (Standard Deviation)36
4 mg LY2127399 Q12W2.319 lesions per scan4.145 (Standard Deviation)36
120 mg LY2127399 Q12W1.422 lesions per scan3.058 (Standard Deviation)34
Placebo1.758 lesions per scan3.615 (Standard Deviation)33

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
4 mg LY2127399 Q4W, Treatment352 (5.7%)
12 mg LY2127399 Q4W, Treatment344 (11.8%)
40 mg LY2127399 Q4W, Treatment342 (5.9%)
120 mg LY2127399 Q4W, Treatment363 (8.3%)
4 mg LY2127399 Q12W, Treatment363 (8.3%)
120 mg LY2127399 Q12W, Treatment352 (5.7%)
Placebo, Treatment351 (2.9%)
4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up352 (5.7%)
12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up342 (5.9%)
40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up344 (11.8%)
120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up361 (2.8%)
4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up363 (8.3%)
120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up355 (14.3%)
Placebo, Post-Study Treatment Follow-Up352 (5.7%)

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

  • Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24

    Weeks 12, 16, 20, and 24

    MRI lesions

  • is to test the hypothesis that subjects with relapsing remitting-multiple sclerosis (RRMS) in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.

    MRI lesions

Other measures (15)

  • Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan

    Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48

    MRI lesions

  • Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

    MRI lesions

  • Total Number of New or Newly Enlarging T2-Weighted MRI Lesions

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

    MRI lesions

  • Total Volume of T2-Weighted MRI Lesions

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

    MRI lesions

  • Expanded Disability Status Scale (EDSS)

    Weeks 12, 24, and 48

    Disability progressionBladder, bowel and sexual function

  • Time to First Relapse

    Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48

    Disability progressionRelapses

  • Percentage of Relapse-Free Participants

    Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)

    Disability progressionRelapses

  • Annualized Relapse Rate (ARR) at Week 24 and Week 48

    Baseline through Week 24 and Baseline through Week 48

    Disability progressionRelapses

  • Multiple Sclerosis Functional Composite Scale (MSFC)

    Weeks 12, 24, and 48

    Disability progressionThinking and memoryWalking and mobilityArm and hand function

  • Visual Analog Scale (VAS) of Wellbeing

    Weeks 12, 24, and 48

Who could take part

Relapsing MS · 18 to 64

Inclusion Criteria: * 18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile). * Women who can become pregnant must use birth control. Exclusion Criteria: * Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study. * Have had had recent surgery or are scheduled to have surgery during the study. * Are immunocompromised or have evidence of active infection [such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)]. * Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS. * Have had a recent serious infection. * Have serious or uncontrolled illnesses other than RRMS. * Have clinically significant blood test values. * Have multiple or severe drug allergies. * Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.

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

About this trial

In the sponsor's words

To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Apr 2009

      2. Main results due

        Feb 2011

      3. Finished

        Jun 2012

      4. Results posted

        Nov 2018

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