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

November 10, 2018 updated by: Eli Lilly and Company

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1407
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Czechia
      • Brno, Czechia, 62500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pardubice, Czechia, 500 05
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Prague, Czechia, 140 59
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • France
      • Caen, France, 14033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Montpellier, France, 34295
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nimes, France, 30900
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Strasbourg, France, 67091
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Germany
      • Berlin, Germany, 13156
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ulm, Germany, 89075
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Hungary
      • Budapest, Hungary, 1095
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gyor, Hungary, 9023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gyula, Hungary, 5700
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Israel
      • Tel Hashomer, Israel, 52621
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Poland
      • Gdansk, Poland, 80-952
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gliwice, Poland, 44-100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Grodzisk Mazowiecki, Poland, 05-825
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Krakow-Nowa Huta, Poland, PL-31-826
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lodz, Poland, 90-549
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lublin, Poland, 20-090
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Romania
      • Targu Mures, Romania, 540136
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Russian Federation
      • Kazan, Russian Federation, 4420029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kemerovo, Russian Federation, 650066
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Moscow, Russian Federation, 119435
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Serbia
      • Belgrade, Serbia, 11000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nis, Serbia, 18000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kosice, Slovakia, 04011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Spisska Nova Ves, Slovakia, 05201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zilina, Slovakia, 01001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49027
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk, Ukraine, 83037
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ivano-Frankivsk, Ukraine, 76008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kharkiv, Ukraine, 61000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vinnytsya, Ukraine, 21005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zaporizhzhya, Ukraine, 69057
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tucson, Arizona, United States, 85741
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • Fullerton, California, United States, 92835
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Denver, Colorado, United States, 80220
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Naples, Florida, United States, 34102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Plantation, Florida, United States, 33324
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sarasota, Florida, United States, 34239
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maine
      • Biddeford, Maine, United States, 04005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Schenectady, New York, United States, 12308
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Raleigh, North Carolina, United States, 27607
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Akron, Ohio, United States, 44320
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Green, Ohio, United States, 44685
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Memphis, Tennessee, United States, 38120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Lubbock, Texas, United States, 79410
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Round Rock, Texas, United States, 78681
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Virginia
      • Newport News, Virginia, United States, 23601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roanoke, Virginia, United States, 24018
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Injection: Every 4 weeks in the placebo arm for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20) for a total of 6 doses. Every 4 weeks in the LY2127399 arms [4 milligrams (mg) LY2127399 / 12 weeks and 120 mg LY2127399 / 12 weeks] for 24 weeks (except Week 0 and Week 12).
Drug: Placebo
Administered via Injection
Experimental: 4 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
Administered via Injection
Experimental: 40 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
Administered via Injection
Experimental: 120 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
Administered via Injection
Experimental: 4 mg LY2127399 / 12 weeks

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.

Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
Drug: Placebo
Administered via Injection
Drug: LY2127399
Administered via Injection
Experimental: 120 mg LY2127399 / 12 weeks

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.

Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
Drug: Placebo
Administered via Injection
Drug: LY2127399
Administered via Injection
Experimental: 12 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
Administered via Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
Time Frame: Weeks 12, 16, 20, and 24
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
Weeks 12, 16, 20, and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. Least squares (LS) mean was calculated using an analysis of variance (ANOVA).
Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of new T1-weighted lesions per scan was obtained from the number new T1-weighted lesions observed during a specified week divided by the number of scans performed that same week.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Lesions were measured using T2-weighted proton density MRI scans.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Volume of T2-Weighted MRI Lesions
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Expanded Disability Status Scale (EDSS)
Time Frame: Weeks 12, 24, and 48
The EDSS is a rating scale for quantifying disability in multiple sclerosis (MS) participants. The EDSS has 8 functional systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) each rated on a scale from 0 (normal) to 5 (severe disability) or 0 (normal) to 6 (severe disability). The EDSS score was computed based on an algorithm of these components, and scores ranged from 0.0 (normal neurological exam) to 10.0 (death due to MS) in increments of 0.5.
Weeks 12, 24, and 48
Time to First Relapse
Time Frame: Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. If a relapse did not occur during the specified time frame, the time to the first confirmed relapse was censored to the date of the participant's last available visit at or prior to Week 24, Week 48, and Week 48 for the respective time frames.
Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48
Percentage of Relapse-Free Participants
Time Frame: Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. Percentage of relapse-free participants=[(number of participants who did not relapse)/(number of pts assessed)]*100.
Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)
Annualized Relapse Rate (ARR) at Week 24 and Week 48
Time Frame: Baseline through Week 24 and Baseline through Week 48
The number of confirmed relapses per year, ARR=[(number of relapses from baseline through Week 24 or baseline through Week 48)/(the time in days between the same interval)]*365.25. A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may have not required systemic corticosteroid treatment.
Baseline through Week 24 and Baseline through Week 48
Multiple Sclerosis Functional Composite Scale (MSFC)
Time Frame: Weeks 12, 24, and 48
The MSFC is a composite scale consisting of 3 components [Timed 25-Foot Walk, 9-Hole Peg Test (9-HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT-3)]. The Timed 25-Foot Walk was a quantitative measure of lower extremity function. The 9-HPT was a quantitative measure of upper extremity (arm and hand) function. The PASAT-3 was a measure of cognitive function that specifically assessed auditory information processing speed and flexibility, as well as calculation ability. Component scores ranged from 0 to 60 and were converted to standard scores (z-scores). The MSFC score was calculated as the average of the 3 standardized component scores. Higher MSFC scores reflected better neurological function.
Weeks 12, 24, and 48
Visual Analog Scale (VAS) of Wellbeing
Time Frame: Weeks 12, 24, and 48
The VAS is a 100-millimeter (mm) horizontal line marked with 0 mm = "poor" and 100 mm = "excellent." Participants were asked to assess their wellbeing by making a vertical mark on the scale. The score was computed as the distance from 0 mm to the vertical mark.
Weeks 12, 24, and 48
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
Time Frame: Weeks 12, 24, and 48
The QIDS-SR16 is a 16-item participant-rated measure of depressive symptomatology. Each item corresponds to 1 of 9 criterion domains for depression: change in sleep disturbance [question (Q) 1 through Q4], sad mood (Q5), decrease or increase in appetite and weight (Q6 through Q9), concentration (Q10), self-criticism (Q11), suicidal ideation (Q12), interest (Q13), energy/fatigue (Q14), and psychomotor agitation and retardation (Q15 and Q16). Each question was scored 0 (no problems) to 3 (increased symptoms). The total score=(the highest score from Q1 through Q4)+(Q5 score)+(the highest score from Q6 through Q9)+(the total score for each Q10 through Q14)+(the highest score from Q15 and Q16). A total score of 0 through 5 was considered no depression likely, 6 through 10 was mild depression, 11 through 15 was moderate depression, 16 through 20 was severe depression, and 21 or over was very severe depression.
Weeks 12, 24, and 48
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Time Frame: Weeks 12, 24, and 48
The SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores were calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status or function. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Weeks 12, 24, and 48
Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)
Time Frame: Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.
AUCtau,ss was obtained by conducting a simulation consisting of 1000 participants, which were then used to determine the noncompartmental PK parameters for each regimen.
Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Time Frame: Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108
The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.
Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Time Frame: Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48
Cell surface marker cluster designation (CD)19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive B cells (CD19+IgD+CD27-); immature/transitional (immature/tran) B cells (CD19+IgD-CD27-); switched memory B cells (CD19+IgD-CD27+); and non-switched memory B cells (CD19+IgD+CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count.
Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 10, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12778
  • H9B-MC-BCDJ (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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