Phase 2
N=245
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Relapsing-Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00882999 ↗Enrolled (actual)
245
Serious AEs
7.4%
Results posted
Nov 2018
Primary outcome: 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 lesions per scan
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2127399 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2011
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 | — |
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.
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.