Sutimlimab (BIVV009) ( DrugBank: Sutimlimab )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 61 | 自己免疫性溶血性貧血 | 3 |
61. 自己免疫性溶血性貧血
臨床試験数 : 137 / 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153
| 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 | JPRN-jRCT2031210392 | 07/12/2021 | 27/10/2021 | Sutimlimab (BIVV009) for the adult participants with cold agglutinin disease (CAD) who have completed Phase 3 studies (CARDINAL or CADENZA) in Japan | An open-label study for sutimlimab in participants with cold agglutinin disease (CAD) who have completed the CARDINAL study (BIVV009-03/EFC16215, Part B) or CADENZA study (BIVV009-04/EFC16216, Part B) in Japan | Cold Agglutinin Disease | Drug: sutimlimab (BIVV009) Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv) | Tanaka Tomoyuki | NULL | Not Recruiting | >= 20age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 2 | NCT05132127 (ClinicalTrials.gov) | November 11, 2021 | 11/11/2021 | Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan | An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan | Cold Agglutinin Disease | Drug: sutimlimab | Sanofi | NULL | Active, not recruiting | 20 Years | N/A | All | 7 | Phase 3 | Japan |
| 3 | NCT03347422 (ClinicalTrials.gov) | March 17, 2018 | 16/11/2017 | A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion | Cold Agglutinin Disease | Drug: sutimlimab (BIVV009);Drug: placebo | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 42 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom |