EUCTR2020-000698-26-GB
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
- 90
- Status
- Active, not recruiting
- Last Updated
- 5 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 3 months 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) andcardiac muscle;
Exclusion Criteria
- •Both phases:
- •General criteria:
- •1\. Previous exposure to pamrevlumab;
- •2\. BMI \=40 kg/m2 or weight \>117 kg;
- •3\. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies;
- •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, ataluren) within 5 half\-lives of screening, whichever is longer, with the exception of the systemic corticosteroids,including deflazacort.
- •Cardiac and Pulmonary assessment:
- •5\.Severe uncontrolled heart failure (NYHA Classes III\-IV), including any of the following:
- •a. Need for intravenous diuretics or inotropic support within 8 weeks prior to screening
- •b. Hospitalization for a heart failure exacerbation or arrhythmia within 8 weeks prior to screening;
Outcomes
Primary Outcomes
Not specified
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