A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
• BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck
Locations
United States
Arizona
Phoenix Children's
NOT_YET_RECRUITING
Phoenix
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Delaware
Nemours/Alfred I. duPont Hospital for Children
NOT_YET_RECRUITING
Wilmington
Indiana
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
NOT_YET_RECRUITING
Indianapolis
Missouri
Washington University School of Medicine in St. Louis
NOT_YET_RECRUITING
St Louis
Nebraska
University of Nebraska Medical Center (UNMC) - Diabetes and Endocrinology Center
NOT_YET_RECRUITING
Omaha
New Mexico
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
RECRUITING
Albuquerque
Ohio
The Ohio State University Wexner Medical Center (OSUWMC)
NOT_YET_RECRUITING
Columbus
Oregon
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
NOT_YET_RECRUITING
Portland
Tennessee
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
NOT_YET_RECRUITING
Nashville
Other Locations
Argentina
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
NOT_YET_RECRUITING
Buenos Aires
Australia
Monash University-Monash Medical Centre (MMC)
NOT_YET_RECRUITING
Melbourne
Royal Melbourne Hospital
NOT_YET_RECRUITING
Parkville
Royal North Shore Hospital (RNSH)
NOT_YET_RECRUITING
Saint Leonards
Adults Westmead Hospital
NOT_YET_RECRUITING
Westmead
Canada
University Health Network - Toronto General Hospital - Osteoporosis Clinic
NOT_YET_RECRUITING
Toronto
Denmark
Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
NOT_YET_RECRUITING
Aarhus
Odense Universitetshospital
NOT_YET_RECRUITING
Odense
France
Hopital Edouard Herriot
NOT_YET_RECRUITING
Lyon
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
NOT_YET_RECRUITING
Paris
Netherlands
Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit
NOT_YET_RECRUITING
Leiden
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Isala ziekenhuizen
NOT_YET_RECRUITING
Zwolle
United Kingdom
Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
NOT_YET_RECRUITING
Cambridge
Lothian Health Board, Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Royal National Orthopaedic Hospital NHS Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Kimberly Brown
clinicaltrials@angitiabio.com
818-862-2068
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2029-02
Participants
Target number of participants: 80
Treatments
Experimental: AGA2115 Dose Regimen 1
Participants that complete the double-blind period receiving AGA2115 Dose 1 from study start to Month 12 will continue to a 12-month open-label period. Participants will then receive AGA2115 Dose 2 for Months 12 to 24.
Experimental: AGA2115 Dose Regimen 2
Participants that complete the double-blind period receiving AGA2115 Dose 2 from study start to Month 12 will continue to a 12-month open-label period. Participants will be kept on the same AGA2115 dose for Months 12 to 24.
Experimental: AGA2115 Dose Regimen 3
Participants that complete the double-blind period receiving AGA2115 Dose 3 from study start to Month 12 will continue to a 12-month open-label period. Participants will receive the same AGA2115 dose for Months 12 to 24.
Placebo_comparator: Placebo
Participants that complete the double-blind period receiving placebo from study start to Month 12 will continue to a 12-month open-label period. Participants will receive AGA2115 Dose 3 for Months 12 to 24.
Related Therapeutic Areas
Sponsors
Leads: Angitia Incorporated Limited