NCT04371666Phase 3Terminated

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

Study sponsor: Kyntra Bio

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-02-13Actual

Enrollment · participants98Actual

Source updated2024-03-12Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Duchenne Muscular Dystrophy

Treatments or interventions studied

PamrevlumabDrugAlso known as FG-3019
PlaceboDrug
CorticosteroidsDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in the Total Score of Performance of Upper Limb (PUL) 2.0 Version at Week 52; description: 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 treatment-by-time interaction, with baseline ordinal PUL entry score as covariate.; timeFrame: Baseline, Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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