Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
Public ClinicalTrials.gov record NCT05626855. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Multicenter, Extension Trial to Evaluate the Long-Term Safety and Efficacy of Apitegromab in Patients With Type 2 and Type 3 Spinal Muscular Atrophy Who Completed Previous Investigational Trials of Apitegromab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
Study identification
- NCT ID
- NCT05626855
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 238 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Years and older
- 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
- Apr 17, 2023 (Actual)
- Primary completion
- Nov 1, 2026 (Estimated)
- Completion
- May 2, 2029 (Estimated)
- Last update posted
- Sep 1, 2026
2023 – 2029
United States locations
- U.S. sites
- 25
- U.S. states
- 23
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| UCSD Altman Clinical and Translational Research | La Jolla | California | 92037 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Biomedical Research | Orlando | Florida | 32827 | — |
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | — |
| Washington University Medical Campus | St Louis | Missouri | 63110 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43215 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| University of Texas Southwestern - Pediatric Neurology | Dallas | Texas | 75207 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Children's Specialty Group PLLC (Children's Hospital of The King's Daughters) | Newport News | Virginia | 23606 | — |
| Seattle Children's Hospital | Seattle | Washington | 98115 | — |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | — |
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 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05626855, 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 Sep 1, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05626855 live on ClinicalTrials.gov.