Relapsing-Remitting Multiple SclerosisPhase 2NCT00882999

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

A Phase 2 study testing LY2127399 in people with Relapsing-Remitting Multiple Sclerosis, run by Eli Lilly and Company at 63 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: LY2127399
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 245 participants
Where: 63 sitesin 13 countries
Study dates: Apr 2009to Jun 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

63 sites in 13 countries.

Country

City, postcode or hospital

63 sites in 13 countries

United States27 sites

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Akron, Ohio, 44320
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Biddeford, Maine, 04005
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Charlotte, North Carolina, 28207
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Denver, Colorado, 80220
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Farmington Hills, Michigan, 48334
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Franklin, Tennessee, 37064
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Fullerton, California, 92835
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Green, Ohio, 44685
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Greensburg, Pennsylvania, 15601
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Greenville, South Carolina, 29615
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Indianapolis, Indiana, 46202
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Kansas City, Kansas, 66160
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Lexington, Kentucky, 40513
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Lubbock, Texas, 79410
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Memphis, Tennessee, 38120
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Naples, Florida, 34102
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Newport News, Virginia, 23601
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Northbrook, Illinois, 60062
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Phoenix, Arizona, 85013
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Plantation, Florida, 33324
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Raleigh, North Carolina, 27607
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Roanoke, Virginia, 24018
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Round Rock, Texas, 78681
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Sarasota, Florida, 34239
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Schenectady, New York, 12308
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Toms River, New Jersey, 08755
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Tucson, Arizona, 85741

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Poland6 sites

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Gdansk, 80-952
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Gliwice, 44-100
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Grodzisk Mazowiecki, 05-825
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Krakow-Nowa Huta, PL-31-826
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Lodz, 90-549
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Lublin, 20-090

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Ukraine6 sites

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Dnipro, 49027
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Donetsk, 83037
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Ivano-Frankivsk, 76008
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Kharkiv, 61000
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Vinnytsia, 21005
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Zaporizhzhya, 69057

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France4 sites

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Caen, 14033
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Montpellier, 34295
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Nîmes, 30900
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Strasbourg, 67091

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Slovakia4 sites

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Bratislava, 833 05
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Košice, 04011
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Spišská Nová Ves, 05201
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Žilina, 01001

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Czechia3 sites

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Brno, 62500
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Pardubice, 500 05
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Prague, 140 59

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Hungary3 sites

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Budapest, 1095
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Győr, 9023
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Gyula, 5700

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Russia3 sites

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Kazan', 4420029
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Kemerovo, 650066
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Moscow, 119435

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Germany2 sites

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Berlin, 13156
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Ulm, 89075

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Serbia2 sites

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Belgrade, 11000
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Niš, 18000

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Bulgaria1 site

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Sofia, 1407

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Israel1 site

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Tel HaShomer, 52621

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Romania1 site

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Târgu Mureş, 540136

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About this study

Official title: 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.

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: LY2127399, Placebo
Keywords: Relapsing, Remitting, Multiple Sclerosis, Multiple, Sclerosis, MS, LY2127399
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Recurrence, Multiple Sclerosis, Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2127399Drug
Administered via Injection
PlaceboDrug
Administered via Injection

Study groups in NCT00882999
Study group	Role	What they receive
Placebo	Placebo comparator	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). Receives: Drug: Placebo
4 mg LY2127399 / 4 weeks	Experimental	Injection: 6 doses, one every 4 weeks for 24 weeks. Receives: Drug: LY2127399
40 mg LY2127399 / 4 weeks	Experimental	Injection: 6 doses, one every 4 weeks for 24 weeks. Receives: Drug: LY2127399
120 mg LY2127399 / 4 weeks	Experimental	Injection: 6 doses, one every 4 weeks for 24 weeks. Receives: Drug: LY2127399
4 mg LY2127399 / 12 weeks	Experimental	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). Receives: Drug: LY2127399; Drug: Placebo
120 mg LY2127399 / 12 weeks	Experimental	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). Receives: Drug: LY2127399; Drug: Placebo
12 mg LY2127399 / 4 weeks	Experimental	Injection: 6 doses, one every 4 weeks for 24 weeks. Receives: Drug: LY2127399

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Weeks 12, 16, 20, and 24

Secondary outcomes (15)

Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
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).
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48
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.
Measured: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Lesions were measured using T2-weighted proton density MRI scans.
Measured: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
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.
Measured: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
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.
Measured: Weeks 12, 24, and 48
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.
Measured: Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48
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.
Measured: 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
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.
Measured: Baseline through Week 24 and Baseline through Week 48
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.
Measured: Weeks 12, 24, and 48
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.
Measured: Weeks 12, 24, and 48
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.
Measured: Weeks 12, 24, and 48
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).
Measured: Weeks 12, 24, and 48
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.
Measured: 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)]
The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.
Measured: 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)
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.
Measured: Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2012

First posted17 Apr 2009 (estimated)
Study startApr 2009
Primary completionFeb 2011
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882999
Sponsor's protocol ID: 12778
Other IDs: H9B-MC-BCDJ
Status last verified: Nov 2018
First submitted: 16 Apr 2009
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Relapsing-Remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT00882999
Acronym / sponsor ID: 12778
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Relapsing, Remitting, Multiple Sclerosis, Multiple, Sclerosis, MS, LY2127399
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Feb 2011 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Apr 2009 (estimated)
Results: Posted 15 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboInjection: 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).
4 mg LY2127399 / 4 weeks	Experimental	Drug: LY2127399Injection: 6 doses, one every 4 weeks for 24 weeks.
40 mg LY2127399 / 4 weeks	Experimental	Drug: LY2127399Injection: 6 doses, one every 4 weeks for 24 weeks.
120 mg LY2127399 / 4 weeks	Experimental	Drug: LY2127399Injection: 6 doses, one every 4 weeks for 24 weeks.
4 mg LY2127399 / 12 weeks	Experimental	Drug: LY2127399, Drug: PlaceboDrug: 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).
120 mg LY2127399 / 12 weeks	Experimental	Drug: LY2127399, Drug: PlaceboDrug: 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).
12 mg LY2127399 / 4 weeks	Experimental	Drug: LY2127399Injection: 6 doses, one every 4 weeks for 24 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2127399Administered via Injection	Drug	12 mg LY2127399 / 4 weeks, 120 mg LY2127399 / 12 weeks, 120 mg LY2127399 / 4 weeks, 4 mg LY2127399 / 12 weeks, 4 mg LY2127399 / 4 weeks, 40 mg LY2127399 / 4 weeks
PlaceboAdministered via Injection	Drug	120 mg LY2127399 / 12 weeks, 4 mg LY2127399 / 12 weeks, Placebo

Primary outcome

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.

15 secondary outcomes

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
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Time frame: 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
Total Volume of T2-Weighted MRI Lesions
Time frame: Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Expanded Disability Status Scale (EDSS)
Time frame: 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
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)
Annualized Relapse Rate (ARR) at Week 24 and Week 48
Time frame: Baseline through Week 24 and Baseline through Week 48
Multiple Sclerosis Functional Composite Scale (MSFC)
Time frame: Weeks 12, 24, and 48
Visual Analog Scale (VAS) of Wellbeing
Time frame: Weeks 12, 24, and 48
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
Time frame: 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
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.
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
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

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4 mg LY2127399 Q4W	35	27
12 mg LY2127399 Q4W	34	26
40 mg LY2127399 Q4W	34	30
120 mg LY2127399 Q4W	36	31
4 mg LY2127399 Q12W	36	28
120 mg LY2127399 Q12W	35	28
Placebo	35	27

Primary outcome: 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. Mean (Standard Deviation). Unit: lesions per scan

Measure	4 mg LY2127399 Q4W n = 34	12 mg LY2127399 Q4W n = 31	40 mg LY2127399 Q4W n = 31	120 mg LY2127399 Q4W n = 36	4 mg LY2127399 Q12W n = 36	120 mg LY2127399 Q12W n = 34	Placebo n = 33
Value	1.819 (3.312)	0.710 (1.103)	1.237 (1.999)	1.477 (2.834)	2.319 (4.145)	1.422 (3.058)	1.758 (3.615)

Population analysed: Randomized participants who had a Gd-enhancing T1-weighted MRI lesion for at least 1 time point among Weeks 12, 16, 20, or 24.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4 mg LY2127399 Q4W, Treatment	2 of 35 (5.7%)	21 of 35 (60%)	Not reported
12 mg LY2127399 Q4W, Treatment	4 of 34 (11.8%)	22 of 34 (64.7%)	Not reported
40 mg LY2127399 Q4W, Treatment	2 of 34 (5.9%)	25 of 34 (73.5%)	Not reported
120 mg LY2127399 Q4W, Treatment	3 of 36 (8.3%)	19 of 36 (52.8%)	Not reported
4 mg LY2127399 Q12W, Treatment	3 of 36 (8.3%)	28 of 36 (77.8%)	Not reported
120 mg LY2127399 Q12W, Treatment	2 of 35 (5.7%)	25 of 35 (71.4%)	Not reported
Placebo, Treatment	1 of 35 (2.9%)	17 of 35 (48.6%)	Not reported
4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up	2 of 35 (5.7%)	17 of 35 (48.6%)	Not reported
12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up	2 of 34 (5.9%)	12 of 34 (35.3%)	Not reported
40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up	4 of 34 (11.8%)	16 of 34 (47.1%)	Not reported
120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up	1 of 36 (2.8%)	10 of 36 (27.8%)	Not reported
4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up	3 of 36 (8.3%)	15 of 36 (41.7%)	Not reported
120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up	5 of 35 (14.3%)	14 of 35 (40%)	Not reported
Placebo, Post-Study Treatment Follow-Up	2 of 35 (5.7%)	12 of 35 (34.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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 study director

Eli Lilly and Company

63 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2127399 in people with Relapsing-Remitting Multiple Sclerosis, run by Eli Lilly and Company at 63 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Poland, Ukraine, France, Slovakia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00882999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.