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NCT06508021 · ClinicalTrials.gov registry record · Phase 2
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
A Phase 2 study of Fibrodysplasia Ossificans Progressiva, sponsored by Ashibio.
- Active
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 3
- Study locations
NCT06508021: Active Phase 2 study of Fibrodysplasia Ossificans Progressiva, sponsored by Ashibio.
NCT06508021 is a Phase 2 study of Fibrodysplasia Ossificans Progressiva that is active but no longer recruiting, run by Ashibio. The registered enrollment target is 92 participants, above the 81-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (14% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06508021, a Phase 2 study of Fibrodysplasia Ossificans Progressiva, is active but no longer recruiting, sponsored by Ashibio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research questions, including: * Safety of andecaliximab in participants with FOP * Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; HO) * Whether andecaliximab reduces the number or severity of flare-ups * Pharmacokinetics/pharmacodynamics (PK/PD): How much study drug is in your blood at different times and its impact on blood biomarker(s) * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Primary Outcome
Low dose WBCT-LH (whole body CT less head) is used to create detailed images of soft tissues and bones.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Andecaliximab
Study Locations (3)
California
- University of California San Francisco (UCSF) - San Francisco
Minnesota
- Mayo Clinic - Rochester
Pennsylvania
- University of Pennsylvania - Perelman Center for Advanced Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-10-25 |
| Est. Completion | 2029-02-04 |
| Phase | Phase 2 |
What the registry record for NCT06508021 still lists
NCT06508021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 81-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06508021 reports a single indexed study location in California, Minnesota, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06508021 about?
NCT06508021 is a clinical study titled "A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)". This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research q...
What is the current status of trial NCT06508021?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2024-10-25. Estimated completion is 2029-02-04.
What conditions does trial NCT06508021 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.
What interventions are being tested in trial NCT06508021?
The interventions under investigation include: Placebo (DRUG), Andecaliximab (DRUG).
Who is sponsoring clinical trial NCT06508021?
This trial is sponsored by Ashibio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06508021 being conducted?
This trial has 3 study locations across California, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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