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COMPLETED Phase 3

Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam

NCT05156320 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 188 participants
Start Date 2022-04-14
Est. Completion 2024-12-18
Phase Phase 3

Sponsor

Scholar Rock

5 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scholar Rock, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05156320 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05156320?

The interventions under investigation include: Placebo (DRUG), Apitegromab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05156320?

This trial is sponsored by Scholar Rock, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial