Clinical Trials Logo
  1. Home
  2. Duchenne Muscular Dystrophy
  3. NCT04371666

Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD) — LELANTOS-1  

Duchenne Muscular Dystrophy Clinical Trial

Official title:
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)

Clinical Trial Summary

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in participants with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

Clinical Trial Description

This is a global, Phase 3, randomized, double-blind trial of pamrevlumab or placebo in combination with systemic corticosteroids in participants with non-ambulatory Duchenne muscular dystrophy, aged 12 years and older. Approximately 90 male participants will be randomized at a 1:1 ratio to Arm A (pamrevlumab + systemic corticosteroid) or Arm B (placebo+ systemic corticosteroid), respectively. Participants must be fully informed of the potential benefits of approved products and make an informed decision that they prefer to participate in a clinical trial in which they could be randomized to placebo. This trial has 3 study periods: - Screening period: Up to 4 weeks - Treatment period: 52 weeks - Safety Follow-up period/End of Study (EOS): A visit 28 days (+/- 3 Days) and a final safety follow-up phone call 60 days (+ 3 Days) after the last dose In the screening period, participants will be evaluated per the protocol inclusion/exclusion criteria to determine eligibility for participation in this trial. During the treatment period, each participant will receive pamrevlumab or placebo at 35 mg/kg every 2 weeks for up to 52 weeks. Participants who complete the 52-week study (either arm) may be eligible for rollover into an open-label extension treatment (OLE) with pamrevlumab + systemic corticosteroids. Participants who discontinue study treatment for any reason should be encouraged to return to the investigative site to complete final safety and efficacy assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04371666
Study type Interventional
Source FibroGen
Contact
Status Terminated
Phase Phase 3
Start date August 10, 2020
Completion date August 17, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT05575648 - Dual Task in Duchenne Muscular Dystrophy N/A
Terminated NCT03907072 - Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2/Phase 3
Not yet recruiting NCT06450639 - An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy Phase 2
Completed NCT04335942 - Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor N/A
Active, not recruiting NCT04906460 - Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53) Phase 1/Phase 2
Active, not recruiting NCT02500381 - Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD) Phase 3
Enrolling by invitation NCT05967351 - A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study Phase 3
Recruiting NCT03067831 - Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy Phase 1/Phase 2
Recruiting NCT01834040 - Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy Phase 1/Phase 2
Completed NCT02246478 - A Study of TAS-205 for Duchenne Muscular Dystrophy Phase 1
Active, not recruiting NCT01772043 - Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping N/A
Terminated NCT01168908 - Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy Phase 2
Completed NCT00758225 - Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Phase 2
Completed NCT03680365 - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Recruiting NCT03513367 - The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.
Recruiting NCT05712447 - Duchenne Muscular Dystrophy Video Assessment Registry
Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Completed NCT03319030 - Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)
Terminated NCT01753804 - A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy. N/A
Completed NCT02530905 - Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients Phase 1