Phase 2
Completed N=245
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Source: ClinicalTrials.gov NCT00882999 ↗Enrolled (actual)
245
Serious AEs
7.4%
Results posted
Nov 2018
Primary outcomePrimary: Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24 — 1.819; 0.710; 1.237; 1.477 lesions per scan
Summary
To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24 |
1.819; 0.710; 1.237; 1.477; 2.319; 1.422 | — |
| SECONDARY Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan |
-0.2; -0.3; -0.3; -0.3; 0.0; -0.3 | — |
| SECONDARY Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan |
1.1; 0.6; 0.6; 0.5; 1.9; 0.9 | — |
| SECONDARY Total Number of New or Newly Enlarging T2-Weighted MRI Lesions |
1.5; 0.7; 0.7; 0.9; 2.1; 1.4 | — |
| SECONDARY Total Volume of T2-Weighted MRI Lesions |
8.7; 7.6; 6.3; 8.7; 10.5; 6.8 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) |
2.96; 2.75; 2.65; 2.17; 2.54; 2.54 | — |
| SECONDARY Time to First Relapse |
139.54; 141.56; 154.73; 153.72; 140.06; 151.23 | — |
| SECONDARY Percentage of Relapse-Free Participants |
72.4; 82.8; 77.4; 84.8; 79.3; 83.9 | — |
| SECONDARY Annualized Relapse Rate (ARR) at Week 24 and Week 48 |
0.75; 0.80; 0.33; 0.38; 0.67; 0.51 | — |
| SECONDARY Multiple Sclerosis Functional Composite Scale (MSFC) |
0.11; 0.08; -0.02; 0.06; -0.02; 0.26 | — |
| SECONDARY Visual Analog Scale (VAS) of Wellbeing |
55.86; 61.09; 63.20; 65.78; 59.67; 64.67 | — |
| SECONDARY 16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16) |
7.79; 6.78; 7.13; 5.94; 7.47; 6.42 | — |
| SECONDARY Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores |
40.96; 45.53; 44.30; 45.57; 42.80; 42.29 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) |
161; 724; 4405; 16603; 146; 13608 | — |
| SECONDARY Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)] |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts) |
18.2; 23.8; 26.9; 28.3; 18.6; 16.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00882999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.