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NCT04371666 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)
A Phase 3 study, sponsored by Kyntra Bio.
- Terminated
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT04371666: Clinical Trial Phase 3 study, sponsored by Kyntra Bio.
NCT04371666 is a Phase 3 study that was terminated before completion, run by Kyntra Bio. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04371666, a Phase 3 study, was terminated before completion, sponsored by Kyntra Bio.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study 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).
Primary Outcome
The PUL module is an observer-administered performance battery of upper extremity mobility tasks for the shoulder (upper, 6 items, 12 points), elbow (middle, 9 items, 17 points) and wrist/hand (distal, 7 items, 13 points). Higher scores indicate higher level of function. Total score ranges from 0-42 points and is the sum of the scores for the 3 subscales. Analysis was done using a random coefficient model (RCM), which included fixed effects of time (as a continuous variable), treatment, and trea
Interventions
- DRUG Placebo
- DRUG Corticosteroids
- DRUG Pamrevlumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2023-08-17 |
| Phase | Phase 3 |
Why NCT04371666 stopped before completion
NCT04371666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04371666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04371666 about?
NCT04371666 is a clinical study titled "Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)". 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).
What is the current status of trial NCT04371666?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2020-08-10. Estimated completion is 2023-08-17.
What interventions are being tested in trial NCT04371666?
The interventions under investigation include: Placebo (DRUG), Corticosteroids (DRUG), Pamrevlumab (DRUG).
Who is sponsoring clinical trial NCT04371666?
This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04371666's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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