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NCT03921528 · ClinicalTrials.gov registry record · Phase 2

An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy

A Phase 2 study of Spinal Muscular Atrophy and Neuromuscular Diseases, sponsored by Scholar Rock.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target
16
Study locations

NCT03921528 is a Phase 2 study of Spinal Muscular Atrophy and Neuromuscular Diseases that has completed, run by Scholar Rock. The registered enrollment target is 58 participants, below the 107-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (46% lower). The trial reports 16 study locations across 12 states.

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The verdict

NCT03921528, a Phase 2 study of Spinal Muscular Atrophy and Neuromuscular Diseases, has completed, sponsored by Scholar Rock.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target
16
Study locations

Study Summary

The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.

Conditions Studied

Spinal Muscular Atrophy Neuromuscular Diseases Muscular Atrophy, Spinal Spinal Muscular Atrophy Type 3 Neuromuscular Manifestations SMA Atrophy Muscular Atrophy Spinal Muscular Atrophy Type 2

Interventions

  • BIOLOGICAL SRK-015

Study Locations (16)

Other

  • ASST Grande Ospedale Metropolitano Niguarda - Milan
  • Centro Clinico Nemo Pediatrico Policlinico A. Gemelli-Università Cattolica Sacro Cuore - Roma
  • Universitair Medisch Centrum Utrecht - Utrecht
  • Hospital Sant Joan de Déu - Barcelona
  • Hospital Universitari i Politecnic La Fe - Valencia

Arizona

  • Phoenix Children's Hospital - Phoenix

California

  • Stanford University - Palo Alto

Colorado

  • Children's Hospital Colorado - Aurora

Maryland

  • The Johns Hopkins University - Baltimore

Massachusetts

  • Boston Children's Hospital - Boston

Michigan

  • Helen DeVos Children's Hospital - Grand Rapids

New York

  • Columbia University - New York

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2019-04-22
Est. Completion 2024-02-28
Phase Phase 2

Sponsor

Scholar Rock

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03921528

The ClinicalTrials.gov registry entry for NCT03921528 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (46% lower). The listed sponsor is Scholar Rock, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Spinal Muscular Atrophy appearing as the primary indexed condition, and to 1 intervention - of which SRK-015 is the first listed.

NCT03921528 reports 16 study locations spanning 12 distinct geographic areas - top geographies include Other, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT03921528 about?

NCT03921528 is a clinical study titled "An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy". The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.

What is the current status of trial NCT03921528?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2019-04-22. Estimated completion is 2024-02-28.

What conditions does trial NCT03921528 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 NCT03921528?

The interventions under investigation include: SRK-015 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03921528?

This trial is sponsored by Scholar Rock, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03921528 being conducted?

This trial has 16 study locations across Arizona, California, Colorado, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.