Cfz533 (iscalimab) (DrugBank: Iscalimab)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 53 | シェーグレン症候群 | 3 |
| 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 | NCT04541589 (ClinicalTrials.gov) | December 18, 2020 | 14/8/2020 | Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome | A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome | Sjögren's Syndrome | Drug: CFZ533 (iscalimab);Other: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 90 Years | All | 160 | Phase 2 | NULL |
| 2 | EUCTR2020-001942-20-GR (EUCTR) | 04/12/2020 | 12/10/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2020-001942-20-HU (EUCTR) | 16/11/2020 | 17/09/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of |