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

Study acronym: ANDECAL
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v11
  2. Site contacts updated at 1 of 3 sitesv10
  3. Study sites: 4 to 3v9
  4. Site details revised at 1 of 4 sitesv8
  5. Site contacts updated at 4 of 4 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date changed from estimate of Dec 1, 2024 to Oct 25, 2024
    • Site details revised at 1 of 4 sites
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Site contacts updated at 4 of 4 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v3
  5. Start date: Aug 1, 2024 to Dec 1, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06508021
Lead Sponsor Ashibio Inc
Conditions
(from sponsor)		 Fibrodysplasia Ossificans Progressiva
Related terms Hallux Valgus, Inflammation, Muscular Diseases, Musculoskeletal Diseases, Myositis, Myositis Ossificans, Ossification, Heterotopic
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov