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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2127399

Placebo

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Relapsing, Remitting, Multiple Sclerosis, Multiple, Sclerosis, MS, LY2127399

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

4 mg LY2127399 / 4 weeks

40 mg LY2127399 / 4 weeks

120 mg LY2127399 / 4 weeks

4 mg LY2127399 / 12 weeks

120 mg LY2127399 / 12 weeks

12 mg LY2127399 / 4 weeks

Arm Description

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).

Injection: 6 doses, one every 4 weeks for 24 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).

Injection: 6 doses, one every 4 weeks for 24 weeks.

Outcomes

Primary Outcome Measures

Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During 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.

Secondary Outcome Measures

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

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

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.

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

Lesions were measured using T2-weighted proton density MRI scans.

Total Volume of T2-Weighted MRI Lesions

The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.

Expanded Disability Status Scale (EDSS)

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.

Time to First Relapse

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.

Percentage of Relapse-Free Participants

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.

Annualized Relapse Rate (ARR) at Week 24 and 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.

Multiple Sclerosis Functional Composite Scale (MSFC)

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.

Visual Analog Scale (VAS) of Wellbeing

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.

16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)

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.

Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores

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).

Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)

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.

Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]

The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.

Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)

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.

Full Information

NCT ID

NCT00882999

First Posted

April 16, 2009

Last Updated

November 10, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00882999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis

Keywords

Relapsing, Remitting, Multiple Sclerosis, Multiple, Sclerosis, MS, LY2127399

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

4 mg LY2127399 / 4 weeks

Arm Type

Experimental

Arm Description

Injection: 6 doses, one every 4 weeks for 24 weeks.

Arm Title

40 mg LY2127399 / 4 weeks

Arm Type

Experimental

Arm Description

Injection: 6 doses, one every 4 weeks for 24 weeks.

Arm Title

120 mg LY2127399 / 4 weeks

Arm Type

Experimental

Arm Description

Injection: 6 doses, one every 4 weeks for 24 weeks.

Arm Title

4 mg LY2127399 / 12 weeks

Arm Type

Experimental

Arm Description

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).

Arm Title

120 mg LY2127399 / 12 weeks

Arm Type

Experimental

Arm Description

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).

Arm Title

12 mg LY2127399 / 4 weeks

Arm Type

Experimental

Arm Description

Injection: 6 doses, one every 4 weeks for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

LY2127399

Intervention Description

Administered via Injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered via Injection

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Weeks 12, 16, 20, and 24

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Lesions were measured using T2-weighted proton density MRI scans.

Time Frame

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

Title

Total Volume of T2-Weighted MRI Lesions

Description

The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.

Time Frame

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

Title

Expanded Disability Status Scale (EDSS)

Description

Time Frame

Weeks 12, 24, and 48

Title

Time to First Relapse

Description

Time Frame

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

Title

Percentage of Relapse-Free Participants

Description

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.

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)

Title

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

Description

Time Frame

Baseline through Week 24 and Baseline through Week 48

Title

Multiple Sclerosis Functional Composite Scale (MSFC)

Description

Time Frame

Weeks 12, 24, and 48

Title

Visual Analog Scale (VAS) of Wellbeing

Description

Time Frame

Weeks 12, 24, and 48

Title

16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)

Description

Time Frame

Weeks 12, 24, and 48

Title

Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores

Description

Time Frame

Weeks 12, 24, and 48

Title

Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)

Description

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.

Time Frame

Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.

Title

Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]

Description

The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.

Time Frame

Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108

Title

Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)

Description

Time Frame

Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

City

Biddeford

State/Province

Maine

ZIP/Postal Code

04005

Country

United States

Facility Name

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

City

Schenectady

State/Province

New York

ZIP/Postal Code

12308

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

City

Green

State/Province

Ohio

ZIP/Postal Code

44685

Country

United States

Facility Name

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

Facility Name

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

City

Brno

ZIP/Postal Code

62500

Country

Czechia

Facility Name

City

Pardubice

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nimes

ZIP/Postal Code

30900

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1095

Country

Hungary

Facility Name

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Gliwice

ZIP/Postal Code

44-100

Country

Poland

Facility Name

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

City

Krakow-Nowa Huta

ZIP/Postal Code

PL-31-826

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-549

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

City

Kazan

ZIP/Postal Code

4420029

Country

Russian Federation

Facility Name

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

City

Spisska Nova Ves

ZIP/Postal Code

05201

Country

Slovakia

Facility Name

City

Zilina

ZIP/Postal Code

01001

Country

Slovakia

Facility Name

City

Dnepropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

City

Donetsk

ZIP/Postal Code

83037

Country

Ukraine

Facility Name

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

City

Kharkiv

ZIP/Postal Code

61000

Country

Ukraine

Facility Name

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

City

Zaporizhzhya

ZIP/Postal Code

69057

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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