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NCT02515669 · ClinicalTrials.gov registry record · Phase 1

Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD

A Phase 1 study, sponsored by Hoffmann-La Roche.

Terminated
Registry status
Phase 1
Development phase
43
Enrollment target

NCT02515669: Clinical Trial Phase 1 study, sponsored by Hoffmann-La Roche.

NCT02515669 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02515669, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.

TERMINATED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and tolerability of RO7239361 in boys with Duchenne Muscular Dystrophy with any genetic mutation.

Primary Outcome

Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.

Interventions

  • DRUG Placebo
  • DRUG RO7239361

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2015-12-02
Est. Completion 2020-04-15
Phase Phase 1
Hoffmann-La Roche

909 total trials

Why NCT02515669 stopped before completion

NCT02515669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02515669 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02515669 about?

NCT02515669 is a clinical study titled "Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD". The purpose of this study is to determine the safety and tolerability of RO7239361 in boys with Duchenne Muscular Dystrophy with any genetic mutation.

What is the current status of trial NCT02515669?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-12-02. Estimated completion is 2020-04-15.

What interventions are being tested in trial NCT02515669?

The interventions under investigation include: Placebo (DRUG), RO7239361 (DRUG).

Who is sponsoring clinical trial NCT02515669?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02515669's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02515669, the US trial registry maintained by the National Library of Medicine. NCT02515669 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.