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This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGA2115 Dose Regimen 1 | Experimental | 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. |
|
| AGA2115 Dose Regimen 2 | Experimental | 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. |
|
| AGA2115 Dose Regimen 3 | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGA2115 | Drug | Subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline at Month 12 in lumbar spine BMD | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline at Month 3 and 6 in lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) BMD | 3 and 6 months | |
| Percent change from Baseline at Month 12 in total hip, femoral neck, one-third distal radius, and total body (minus head) BMD |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of TEAEs (collection and documentation of all adverse events occurring during the study) | Baseline to 24 months | |
| Evaluation of AGA2115 observed serum concentration levels for the AGA2115 treatment groups | Baseline to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Brown | Contact | 818-862-2068 | clinicaltrials@angitiabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Heather Byers, MD | Angitia Incorporated Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's | Recruiting | Phoenix | Arizona | 85016 | United States |
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| Placebo | Other | Subcutaneous injection |
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| 12 months |
| Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1 | Week 1, Month 1, 3, 6, 9, and 12 |
| Percentage of participants with fractures during the double-blind treatment period | up to 12 months |
| Annualized fracture rate for incident fractures occurring during the double-blind treatment period (total, long-bone, vertebral, peripheral) | up to 12 months |
| Number of participants who develop anti-AGA2115 antibodies | Baseline to 24 months |
| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Nemours/Alfred I. duPont Hospital for Children | Not yet recruiting | Wilmington | Delaware | 19803 | United States |
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| Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Washington University School of Medicine in St. Louis | Not yet recruiting | St Louis | Missouri | 63110 | United States |
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| New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC) | Recruiting | Albuquerque | New Mexico | 87160 | United States |
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| The Ohio State University Wexner Medical Center (OSUWMC) | Not yet recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic | Not yet recruiting | Portland | Oregon | 97239 | United States |
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| Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
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| Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro | Recruiting | Buenos Aires | Argentina |
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| Monash University-Monash Medical Centre (MMC) | Recruiting | Melbourne | Australia |
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| Royal Melbourne Hospital | Recruiting | Parkville | Australia |
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| Royal North Shore Hospital (RNSH) | Recruiting | Saint Leonards | Australia |
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| Adults Westmead Hospital | Not yet recruiting | Westmead | Australia |
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| University Health Network - Toronto General Hospital - Osteoporosis Clinic | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade | Not yet recruiting | Aarhus | Denmark |
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| Odense Universitetshospital | Not yet recruiting | Odense | Denmark |
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| Hopital Edouard Herriot | Not yet recruiting | Lyon | France |
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| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere | Not yet recruiting | Paris | France |
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| Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit | Not yet recruiting | Leiden | Netherlands |
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| Erasmus MC | Not yet recruiting | Rotterdam | Netherlands |
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| Isala ziekenhuizen | Not yet recruiting | Zwolle | Netherlands |
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| Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital | Not yet recruiting | Cambridge | United Kingdom |
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| Lothian Health Board, Western General Hospital | Not yet recruiting | Edinburgh | United Kingdom |
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| Royal National Orthopaedic Hospital NHS Trust | Not yet recruiting | London | United Kingdom |
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| Oxford University Hospitals NHS Foundation Trust | Not yet recruiting | Oxford | United Kingdom |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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