This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT05337553 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Sponsor | Biohaven Pharmaceuticals, Inc. |
| Enrollment | 269 participants |
| Design | Interventional, Randomized, Parallel, Masking: Quadruple |
| Conditions | Spinal Muscular Atrophy; Neuromuscular Diseases; SMA |
| Interventions | taldefgrobep alfa; Placebo; taldefgrobep alfa |
| Start | Jul 6, 2022 |
| Primary completion | Sep 25, 2024 |
| Study completion | Dec 2027 |
| Results posted | Not yet |
| Registry last updated | Jun 1, 2026 |
Compounds on this site that cite this trial
What the registry says the trial is about
This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen and/or risdiplam and/or have a history of onasemnogene abeparvovec, compared to placebo.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Efficacy of taldefgrobep alfa compared to placebo in change in the 32 item Motor Function Measure (MFM-32) total score | Baseline to Week 48 |
8 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 30, 2026. See the trial changes feed for what has changed recently.
More trials of Taldefgrobep alfa
Research area: Related non-peptide compounds. Every registered trial we follow is in the clinical trial tracker, and the labels used on this page are explained in our evidence standards.
