276. Achondroplasia Clinical trials / Disease details
Clinical trials : 46 / Drugs : 29 - (DrugBank : 6) / Drug target genes : 5 - Drug target pathways : 30
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001855-15-ES (EUCTR) | 02/02/2022 | 15/09/2021 | A study to evaluate long-term Infigratinib in children with Achondroplasia | Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE - PROPEL OLE | Achondroplasia in Children MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infigratinib Product Code: BGJ398 (also known as BBP-831) INN or Proposed INN: INFIGRATINIB | QED Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | France;United States;Canada;Spain;Australia;United Kingdom | ||
| 2 | NCT05145010 (ClinicalTrials.gov) | December 6, 2021 | 22/11/2021 | Extension Study of Infigratinib in Children With Achondroplasia (ACH) | Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL OLE | Achondroplasia | Drug: Infigratinib | QED Therapeutics, Inc. | NULL | Recruiting | 3 Years | 18 Years | All | 280 | Phase 2 | Australia;United Kingdom |
| 3 | EUCTR2019-002954-21-FR (EUCTR) | 06/05/2020 | 20/01/2020 | A study to evaluate Infigratinib in children with Achondroplasia | Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2 - PROPEL 2 | Achondroplasia in Children MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infigratinib phosphate Product Code: BGJ398 (also known as BBP-831) INN or Proposed INN: INFIGRATINIB | QED Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Australia;United Kingdom | ||
| 4 | EUCTR2019-002954-21-GB (EUCTR) | 31/03/2020 | 13/05/2020 | A study to evaluate Infigratinib in children with Achondroplasia | Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2 - PROPEL 2 | Achondroplasia in Children MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infigratinib phosphate Product Code: BGJ398 (also known as BBP-831) INN or Proposed INN: INFIGRATINIB | QED Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 78 | Phase 2 | United States;France;Canada;Spain;Australia;United Kingdom | ||
| 5 | NCT04265651 (ClinicalTrials.gov) | March 10, 2020 | 29/1/2020 | Study of Infigratinib in Children With Achondroplasia | Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL 2 | Achondroplasia | Drug: Infigratinib 0.016 mg/kg;Drug: Infigratinib 0.032 mg/kg;Drug: Infigratinib 0.064 mg/kg;Drug: Infigratinib 0.128 mg/kg | QED Therapeutics, Inc. | NULL | Recruiting | 3 Years | 11 Years | All | 78 | Phase 2 | United States;Australia;Canada;France;Spain;United Kingdom |