A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP) (NCT06508021) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
United States92 participantsStarted 2024-10-25
Plain-language 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)
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
✓. Participant and/or guardian able and willing to give informed consent and/or assent as applicable, and willing to adhere to the visits schedule and study procedures.
✓. Clinical diagnosis of FOP including congenital malformation(s) consistent with FOP (e.g., of the great toes), and either episodic soft tissue swelling consistent with an FOP flare-up and/or progressive HO.
✓. Male or female ≥ 15 years of age.
✓. Serum creatinine ≤ upper limit of normal for age.
✓. No open growth plates on bilateral PA hand/wrist or AP knee films at baseline
✓. Able to receive IV radiotracer \[both IV access and no history of a reaction to radiotracer\].
✓. No use of bisphosphonates or bone active agent within the past year.
✓. At least 1 active HO lesion at baseline per Na18F PET/CT
Exclusion criteria
✕. Body weight \<10kg
What they're measuring
1
Number of New HO Lesions as Assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)]