A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).

Official Title
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A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: ELND002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year Has had an inadequate response or intolerability to interferon and/or glatiramer acetate Is able and willing to undergo Gd administration and repeat MRI testing Exclusion Criteria: Has primary progressive MS (PPMS) Any history of treatment with recombinant humanized monoclonal antibodies Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline Any history of congestive heart failure or currently has a pacemaker Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug Has any medical history or psychiatric condition that would impact outcome or study participation Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELND002<br>ELND002 sc injection | Drug: ELND002<br> <br> |
| Placebo Comparator: Placebo<br>placebo injection | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS). |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) | Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM. | 12 weeks | 
| Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions |  | 12 weeks | 
| Reduction in rate of clinical relapses. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)