Clinical Trial

A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

Study acronym: ANDECAL
Active, Not Recruiting Phase 2/3
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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)
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-07-12; most recent amendment 2025-10-09.
Status change: Recruiting → Active, Not Recruiting 2025-10-09
Status change: Not Yet Recruiting → Recruiting 2024-11-07
Trial Details
NCT Number NCT06508021
Lead Sponsor Ashibio Inc
Conditions Fibrodysplasia Ossificans Progressiva
Enrollment 92 participants
Start Date 2024-10-25
Primary Completion 2029-02-04 (estimated)
Study Completion 2029-02-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-14