EUCTR2020-000698-26-BE
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-ambulatory Duchenne Muscular Dystrophy
- Sponsor
- FibroGen, Inc.
- Enrollment
- 92
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Double\-blind phase:
- •Age, Consent, and Contraception
- •1\. Males at least 12 years of age, non\-ambulatory at screening initiation;
- •2\. Written consent by patient and/or legal guardian as per regional/ country and/or IRB/IEC requirements;
- •3\. Male subjects with partners of childbearing potential must use contraception during the conduct of the study, and for 12 weeks after the last dose of study drug.
- •DMD Diagnosis:
- •4\. Medical history includes diagnosis of DMD and confirmed Duchenne mutation using a validated genetic test.
- •Performance criteria:
- •5\. Brooke Score for Arms and Shoulders \=5:
- •6\. Able to undergo MRI test for the upper arm extremities (Biceps Brachii muscle) and cardiac muscle;
Exclusion Criteria
- •Both phases:
- •General criteria:
- •1\. Previous exposure to pamrevlumab;
- •2\. BMI \=40 kg/m2 or weight \>117 kg;
- •3\. History of:
- •a. allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies,
- •b. hypersensitivity to study drug or any component of study drug,
- •c. hypersensitivity reaction to Gadolinium\-based Contrast Agents (GBCA) required for MRI acquisition;
- •4\. Exposure to any investigational drug (for DMD or not), in the 30 days prior to screening initiation or use of approved DMD therapies (e.g., eteplirsen (exondys 51\), ataluren, golodirsen (vyondys 53\), casimersen (amondys 45\)) within 5 half\-lives of screening, whichever is longer, with the exception of the systemic corticosteroids, including deflazacort.
- •Cardiac, Renal and Pulmonary assessment:
Outcomes
Primary Outcomes
Not specified
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