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Clinical Trials/EUCTR2020-000698-26-AT
EUCTR2020-000698-26-AT
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)

FibroGen, Inc.0 sites92 target enrollmentAugust 17, 2020
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Conditionson-ambulatory Duchenne Muscular DystrophyMedDRA version: 20.0Level: PTClassification code 10013801Term: Duchenne muscular dystrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 17, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

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) 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:
  • •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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