A Study of Patients With Relapsing Remitting Multiple Sclerosis - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00882999

Purpose

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

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: LY2127399 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total number of Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
Total number of new or newly enlarging T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
Time to first relapse. [ Time Frame: Weeks 24, 48 and period in between. ] [ Designated as safety issue: No ]
Proportion of relapse-free subjects. [ Time Frame: Weeks 24, 48 and period in between. ] [ Designated as safety issue: No ]
Proportion of subjects with anti-LY2127399 antibodies. [ Time Frame: 24, 48, and 72 weeks ] [ Designated as safety issue: No ]
Pharmacodynamics of selected peripheral B cell subsets. [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Serum pharmacokinetics (AUC). [ Time Frame: 42 weeks ] [ Designated as safety issue: No ]
Expanded Disability Status Scale (EDSS). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
Multiple Sclerosis Functional Composite Scale (MSFC). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
Visual Analog Scale (VAS) of Wellbeing. [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
Total number of new Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
Total volume of T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
Annualized relapse rate. [ Time Frame: Weeks 24 and 48. ] [ Designated as safety issue: No ]

Estimated Enrollment:	245
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2012
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Injection: Every 4 weeks in the placebo arm for 24 weeks. Every 4 weeks in the LY arms for 24 weeks (except week 12 and week 24).
Experimental: 4 mg LY2127399 / 4 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 40 mg LY2127399 / 4 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 120 mg LY2127399 / 4 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 4 mg LY2127399 / 12 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks. Drug: Placebo Injection: Every 4 weeks in the placebo arm for 24 weeks. Every 4 weeks in the LY arms for 24 weeks (except week 12 and week 24).
Experimental: 120 mg LY2127399 / 12 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks. Drug: Placebo Injection: Every 4 weeks in the placebo arm for 24 weeks. Every 4 weeks in the LY arms for 24 weeks (except week 12 and week 24).
Experimental: 12 mg LY2127399 / 4 weeks	Drug: LY2127399 Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 through 64 years of age diagnosed with relapsing-remitting multiple sclerosis (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 magnetic resonance imaging (MRI; "scanning") or claustrophobia (fear of an enclosed space) that cannot be managed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882999

Show 63 Study Locations

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00882999 History of Changes
Other Study ID Numbers:	12778, H9B-MC-BCDJ
Study First Received:	April 16, 2009
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration Belgium: Directorate general for the protection of Public health: Medicines Canada: Health Canada Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Israel: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ministry of Health and Social Development of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Switzerland: Swissmedic Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Eli Lilly and Company:

Relapsing
Remitting
Multiple Sclerosis
Multiple

Sclerosis
MS
ms
LY2127399

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012