NCT02606136

Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

Trial of Pamrevlumab (FG-3019), a Monoclonal Antibody to Connective Tissue Growth Factor, in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate pamrevlumab's safety and efficacy in non-ambulatory participants with DMD.

Detailed description

The study will include a screening period, main study period, open-label extension (OLE) period, and follow-up period 4 weeks after the last dose. All participants who complete the main portion of the study for a minimum of 104 weeks (2 years) will be rolled over to an OLE for up to an additional 208 weeks (4 years).

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Pamrevlumab	Pamrevlumab, 10 milligrams (mg)/milliliter (mL), single dose vials

Timeline

• Start date: 2016-01-04
• Primary completion: 2020-05-07
• Completion: 2023-08-09
• First posted: 2015-11-17
• Last updated: 2024-08-27
• Results posted: 2021-12-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study