Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N/a
CAS Number: N/a
Current Sponsor code: LY2127399
Other descriptive name:
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective The primary objective of this study is to test the hypothesis that subjects with RRMS in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.;Secondary Objective: To determine or evaluate: Safety/tolerability of LY2127399 (LY) compared to placebo. Whether Total: number of Gd-enhancing MRI lesions, number of new Gd-enhancing MRI lesions, number of new or newly enlarging T2-weighted MRI lesions, and volume of T2-weighted MRI lesions are statistically significantly less in =1 LY group compared to placebo over the 48-week duration of the study. Whether the time to first relapse is statistically significantly longer in 1 or more LY groups compared to placebo. Whether the proportion of relapse-free subjects is greater, and whether there is a smaller annualized relapse rate over 24 and 48 weeks in =1 LY group compared to placebo. Proportion of subjects with anti-LY antibodies at the end of the study. PD of selected peripheral B cell subsets following administration of LY compared to placebo. Serum PK of LY after multiple doses. Effect of treatment with LY compared to placebo on EDSS, MSFC, VAS of Wellbeing, SF-36, and QIDS-SR16. ;Primary end point(s): is to test the hypothesis that subjects with relapsing remitting-multiple sclerosis (RRMS) in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group. | — |
Countries
Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary
Outcome results
None listed