CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
SRK-015biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03921528
NCT03921528Phase 2Completed
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Phase 2 Active Treatment Study to Evaluate the Efficacy and Safety of SRK-015 in Patients With Later-Onset Spinal Muscular Atrophy (TOPAZ)

Scholar Rock, Inc.·interventional·Posted Apr 19, 2019·Updated Dec 2, 2024

In Brief

A Phase 2 clinical trial evaluating SRK-015 for Spinal Muscular Atrophy and 8 related conditions. Completed, enrolled 58 participants across 16 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2, SMA, Neuromuscular Diseases, Muscular Atrophy, Atrophy, Muscular Atrophy, Spinal, Neuromuscular Manifestations
CountriesItaly, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 19, 2019
Enrollment StartApr 22, 2019
Primary CompletionJan 19, 2021
Study CompletionFeb 28, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.2 years ago

Interventions

SRK-015biological

SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 will be administered every 4 weeks by intravenous infusion.