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

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2008-007459-28-DK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-29
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Inclusion Criteria
Subjects are eligible to be included in the study only if they meet all of the following
criteria:
[1] Qualify as having RRMS prior to Visit 2, based on the disease diagnostic criteria as defined by revised McDonald Criteria (Polman et al. 2005). (Search revised McDonald Criteria at http:// www.nationalmssociety.org).
[2] A Kurtzke EDSS (Kurtzke 1983) score of 0 through 5.0. This would include subjects who are ambulatory.
[3] Have at least 1 documented clinical relapse within 12 months prior to Visit 2; OR show evidence of Gd-enhancing lesion(s) of the brain or spine by MRI performed within 12 months prior to Visit 2.[4] Are 18 to 64 years of age, inclusive.
[5] Inclusion criterion [5] only applies to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause). These females must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study or for at least 8 weeks after the last injection of study drug, which ever is longer
(for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Have MS categorized as primary progressive, secondary progressive or progressive relapsing.
•Have had a relapse within 30 days and/or have not stabilized from a previous relapse and/or have had systemic corticosteroid therapy within 30 days prior to randomization.
•Have greater than 15 Gd-enhancing lesions of the brain by MRI performed between Visits 1 and 2.
•Have received any B cell biological therapies (such as rituximab, ocrelizumab, ofatumumab, belimumab, atacicept, or BR3-Fc); or have had treatment with cyclophosphamide, mitoxantrone, mycophenolate mofetil, or cladribine within the previous year; interferon beta or glatiramer acetate within 3 months prior to randomization; or cyclosporine, azathioprine, methotrexate, or intravenous immune globulin, plasmapheresis or cytapheresis within 6 months prior to randomization; or other biological agent/monoclonal antibody within 3 months prior to randomization; or a non-biologic drug or device that has not received regulatory approval for any indication within 30 days prior to the time of study entry.
•Have had a live vaccination within 3 months before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 3 months prior to randomization.
•Have had elective surgery within 2 weeks prior to randomization or are scheduled to have 1 during the study.
•Are immunocompromised; or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection. However, subjects with a history of active or latent TB who have documented evidence of adequate treatment may be enrolled in the study. Subjects who have had household contact with a person with active TB are excluded, unless appropriate and documented prophylaxis for TB was given..
•Have history of or current lymphoproliferative disease, malignant disease (except for resolved basal or squamous carcinoma); have significant allergies to humanized monoclonal antibodies or clinically significant or severe drug allergies/hypersensitivity; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic (other than MS), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, would place the subject at increased safety risk and/or could interfere with the analyses of safety and efficacy in this study.
•Have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
•Have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of the reference range.
•Have hematology and/or serum chemistry laboratory test values outside the reference range for the population or investigative site that are considered clinically significant; and/or have specific abnormalities of white blood cells <3 G/L, lymphocytes <0.8 G.L, polymorphonuclear leukocytes <1.5 G/L, platelets <100 G/L, aspartate transaminase (AST) or alanine transaminase (ALT) >2 x upper limit of normal (ULN), bilirubin >1.5 x ULN, abnormal thyroid function, serum creatinine of >177 µmol/L, or a calculated creatinine clearance <60 mL/min.
•Have contraindications for MRI: pacemakers or other containdicated implanted metal devices, allergy to gadolinium, of

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified