Clinical Trials Logo
  1. Home
  2. Spinal Muscular Atrophy Type 3
  3. NCT05156320

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

Neuromuscular Diseases Clinical Trial

Official title:
Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

Clinical Trial Summary

This Phase 3 trial (Study SRK-015-003) is being 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 are 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05156320
Study type Interventional
Source Scholar Rock, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 24, 2022
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT04435093 - Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT05785546 - Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Active, not recruiting NCT05070624 - The Peer Support Study N/A
Completed NCT04729920 - Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
Recruiting NCT04581577 - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Enrolling by invitation NCT05539456 - Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Completed NCT05353738 - Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
Recruiting NCT04541602 - Detection of Neuromuscular Complications in Critically Ill Patients
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III
Enrolling by invitation NCT05099107 - Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment N/A
Completed NCT05070910 - NDT Effectiveness Study N/A
Recruiting NCT04100993 - Multisystem and Autonomic Complications of NMD on Long-term NIV
Recruiting NCT04986059 - Effects of Pre-event Massage on Muscle Activity N/A
Completed NCT01022931 - Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva N/A
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A