Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07047144 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy

Study acronym: OPAL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 2 of 3 entries
    • Study sites: 24 to 23
    • Eligibility criteria expanded, about 10 words
  2. Study sites: 25 to 24v8
  3. Study sites: 23 to 25v7
  4. Study sites: 14 to 23v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 4 to 14v4
  2. Study sites: 2 to 4
    • Start date changed from estimate of Sep 2025 to Sep 15, 2025
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This double-blind, Phase 2, multiple-dose study will be conducted to evaluate the PK/PD, efficacy, safety, and tolerability of apitegromab in subjects \<2 years old with 5q autosomal recessive SMA who have delayed motor milestones for their age attributed to SMA at the discretion of the Investigator or a Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) score \<55.
Trial Details
NCT Number NCT07047144
Lead Sponsor Scholar Rock, Inc.
Conditions
(from sponsor)		 Spinal Muscular Atrophy, SMA, Spinal Muscular Atrophy Type 2, Spinal Muscular Atrophy Type 3, Neuromuscular Manifestations, Anti-myostatin
Related terms Muscular Atrophy, Spinal, Neuromuscular Manifestations, Spinal Muscular Atrophies of Childhood
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov