MedTrace Logo

Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD

NCT04632940 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-08-26

Study results available
· View outcomes & findings →

Summary

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every 2 weeks in ambulatory participants with Duchenne muscular dystrophy (DMD) (age 6 to \<12 years).

Conditions

Interventions

DRUG

Pamrevlumab

Pamrevlumab will be administered per dose and schedule specified in the arm description.

DRUG

Placebo

Placebo will be administered per schedule specified in the arm description.

DRUG

Corticosteroids

Systemic deflazacort or equivalent potency of corticosteroids administered orally

Sponsors & Collaborators

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2023-06-12
Completion
2023-12-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632940 on ClinicalTrials.gov