ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 2/3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study With Open-Label Extension (OLE) to Assess the Efficacy and Safety of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

Quick Facts

Study Start:2024-10-25
Study Completion:2029-02-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06508021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Body weight \<10kg
  2. 2. Known non-healed fracture at time of Study Day 1.
  3. 3. Planned surgery within the timeframe of the study duration or still recovering from recent surgery.
  4. 4. Respiratory compromise that requires use of supplemental oxygen.
  5. 5. Participant has
  6. * Known monogenic disorder other than FOP.
  7. * Bone or mineral disorder unrelated to FOP.
  8. 6. Malignancy (within the past 5 years, except non-melanoma skin cancer, cervical carcinoma in situ, or ductal carcinoma in situ \[DCIS\]).
  9. 7. Known active infection (including fungal, bacterial, mycobacterial, or viral infection including COVID19)
  10. 8. Uncontrolled hypoparathyroidism or hyperparathyroidism.
  11. 9. Per participant report or chart review (no testing required): Uncontrolled hyperthyroidism
  12. 10. Use of the following medication:
  13. * Systemic corticosteroids with a prednisone equivalent of \>10mg/day within 1 week of Study Day 1. If the participant requires chronic use of \>10mg/day prednisone equivalent of corticosteroids, eligibility will be discussed with the Sponsor.
  14. * NSAIDs of higher than doses recommended by the May 2022 ICCFOP guidelines within 1 week of Study Day 1. If the participant requires chronic use of NSAIDs at doses higher than those recommended by the May 2022 ICCFOP guidelines doses, eligibility will be discussed with the Sponsor.
  15. * Current or chronic use of tetracycline drugs (e.g., tetracycline, demeclocycline, doxycycline, or minocycline).
  16. 11. Chronic use of any of unproven therapies for FOP.
  17. 12. Palovarotene
  18. * Within 1 month of Study Day 1 for all participants
  19. * Within 2 years of Study Day 1 for female participants \<8 years of age Or male participants \<10 years of age
  20. 13. Treatment with another investigational product within 5 half lives of last dose at the time of Study Day 1 or 1 month, whichever is longer.
  21. 14. History of allergy or hypersensitivity to andecaliximab or its excipients.
  22. 15. Significant current laboratory abnormalities
  23. 16. Breastfeeding, pregnant, or planning pregnancy.
  24. 17. Those of childbearing potential unwilling to agree to abstain from sexual activity that could result in pregnancy or unwillingness to use acceptable birth control during the study and for 90 days after the last dose.
  25. 18. Simultaneous participation in another clinical trial involving another investigational product.
  26. 19. Significant medical condition or disability or biochemical or hematologic abnormalities that in the opinion of the Investigator would expose the participant to undue risk, prevent the conduct of study procedures, or confound the study results.

Contacts and Locations

Study Locations (Sites)

University of California San Francisco (UCSF)
San Francisco, California, 94143
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Ashibio Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-25
Study Completion Date2029-02-04

Study Record Updates

Study Start Date2024-10-25
Study Completion Date2029-02-04

Terms related to this study

Keywords Provided by Researchers

  • Myositis Ossificans
  • Ossification, Heterotopic
  • Hallux Valgus
  • Matrix Metalloproteinase Inhibitors
  • Matrix Metalloproteinase 9
  • Inflammation
  • Activin A receptor, type I protein, human
  • ALK-2 protein, human
  • ACVR1 protein, human
  • Muscle, Skeletal
  • Myositis
  • Muscular diseases
  • Musculoskeletal diseases
  • Flare
  • Flare-ups
  • ANDECAL
  • Heterotopic bone
  • Ectopic bone
  • Munchmeyer's Disease

Additional Relevant MeSH Terms

  • Fibrodysplasia Ossificans Progressiva