Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05156320 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
A Phase 3 study of Spinal Muscular Atrophy and Neuromuscular Diseases, sponsored by Scholar Rock.
- Completed
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
- 20
- Study locations
NCT05156320 is a Phase 3 study of Spinal Muscular Atrophy and Neuromuscular Diseases that has completed, run by Scholar Rock. The registered enrollment target is 188 participants, above the 101-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 18 states.
The verdict
NCT05156320, a Phase 3 study of Spinal Muscular Atrophy and Neuromuscular Diseases, has completed, sponsored by Scholar Rock.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 trial (Study SRK-015-003) was conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and were receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Apitegromab
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- Stanford University Medical Center - Palo Alto
- Rady's Children's Hospital/UCSD - San Diego
Alabama
- Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Nemours Children's Hospital - Orlando
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156320
The ClinicalTrials.gov registry entry for NCT05156320 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (86% higher). The listed sponsor is Scholar Rock, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Spinal Muscular Atrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05156320 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05156320 about?
NCT05156320 is a clinical study titled "Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam". This Phase 3 trial (Study SRK-015-003) was conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and were receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusiners...
What is the current status of trial NCT05156320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2022-04-14. Estimated completion is 2024-12-18.
What conditions does trial NCT05156320 study?
This clinical trial studies the following conditions: Spinal Muscular Atrophy, Neuromuscular Diseases, Muscular Atrophy, Spinal, Spinal Muscular Atrophy Type 3, Neuromuscular Manifestations.
What interventions are being tested in trial NCT05156320?
The interventions under investigation include: Placebo (DRUG), Apitegromab (DRUG).
Who is sponsoring clinical trial NCT05156320?
This trial is sponsored by Scholar Rock, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05156320 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Muscular Atrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy
ACTIVE NOT RECRUITING · Phase 3
-
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
ACTIVE NOT RECRUITING · Phase 3
-
Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA
RECRUITING
-
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
RECRUITING · NA
-
Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.