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Active, not recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy

ClinicalTrials.gov ID: NCT05337553

Public ClinicalTrials.gov record NCT05337553. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 6:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Ambulatory and Non-Ambulatory Participants With Spinal Muscular Atrophy With Open-Label Extension

Study identification

NCT ID
NCT05337553
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biohaven Pharmaceuticals, Inc.
Industry
Enrollment
269 participants

Conditions and interventions

Interventions

  • taldefgrobep alfa Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
4 Years to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 5, 2022
Primary completion
Sep 24, 2024
Completion
Nov 30, 2027
Last update posted
May 31, 2026

2022 – 2027

United States locations

U.S. sites
30
U.S. states
21
U.S. cities
30
Facility City State ZIP Site status
Phoenix Children's Phoenix Arizona 85016
UCSD & Rady Children's La Jolla California 92037
Children's Hospital of Los Angeles Los Angeles California 90027
UCSF Benioff Children's Hospital, Medical Center San Francisco California 94158
Children's Hospital Colorado Aurora Colorado 80045
UF Health, Shands Hospital Gainesville Florida 32610
Rare Disease Research Atlanta Georgia 30329
Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
Indiana University -Riley Research Indianapolis Indiana 46202
University of Iowa Iowa City Iowa 52242
University of Kansas Medical Center Fairway Kansas 66205
Boston Children's Hospital - Harvard Boston Massachusetts 02115
BSHS Office of Research Grand Rapids Michigan 49503
Washington University in St. Louis St Louis Missouri 63110
Columbia University Medical Center New York New York 10032
Stony Brook University Hospital Stony Brook New York 11794
Duke University Medicine Durham North Carolina 27705
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Nationwide Children's Hospital Columbus Ohio 43205
Penn State College of Medicine Hershey Pennsylvania 17033
CHOP Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
Vanderbilt University Medical Center Nashville Tennessee 37232
UT Pediatric Neurosciences/Dell Children's Medical Center Austin Texas 78723
Neurology Rare Disease Center Denton Texas 75208
Cook Children's Hospital Fort Worth Texas 76104
University of Virginia Children's Hospital Charlottesville Virginia 22903
Children's Hospital of The King's Daughters Norfolk Virginia 23507
MultiCare Institute of Research and Innovation Tacoma Washington 98405
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05337553, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 31, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05337553 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →