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A Study of Patients With Relapsing Remitting Multiple Sclerosis
This study is currently recruiting participants.
Verified by Eli Lilly and Company, November 2009
First Received: April 16, 2009   Last Updated: November 16, 2009   History of Changes
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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


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: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator 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).
4 mg LY2127399 / 4 weeks: Experimental Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
40 mg LY2127399 / 4 weeks: Experimental Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
120 mg LY2127399 / 4 weeks: Experimental Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
4 mg LY2127399 / 12 weeks: Experimental 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).
120 mg LY2127399 / 12 weeks: Experimental 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).
12 mg LY2127399 / 4 weeks: Experimental 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

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 112 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: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 12778, H9B-MC-BCDJ
Study First Received: April 16, 2009
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00882999     History of Changes
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:
Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 20, 2009