51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | EUCTR2021-006271-42-GR (EUCTR) | 04/01/2023 | 02/11/2022 | A Open-label Study to Evaluate the Efficacy, Safety, Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2 | NCT05626751 (ClinicalTrials.gov) | November 4, 2022 | 1/11/2022 | An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc) | A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis;Sclerosis, Systemic | Drug: HZN-825 | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States;Argentina;France;Greece;Korea, Republic of |
| 3 | EUCTR2020-005764-62-NL (EUCTR) | 31/01/2022 | 25/11/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2020-005764-62-PL (EUCTR) | 31/01/2022 | 05/01/2022 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 5 | EUCTR2020-005764-62-IT (EUCTR) | 29/09/2021 | 30/08/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis - - | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: HZN-825 Product Code: [HZN-825] | HORIZON THERAPEUTICS IRELAND DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Korea, Democratic People's Republic of;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 6 | EUCTR2020-005764-62-GR (EUCTR) | 13/09/2021 | 09/07/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 7 | EUCTR2020-005764-62-PT (EUCTR) | 24/08/2021 | 19/08/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of | ||
| 8 | EUCTR2020-005764-62-AT (EUCTR) | 16/08/2021 | 15/06/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 9 | EUCTR2020-005764-62-ES (EUCTR) | 11/08/2021 | 11/08/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of | ||
| 10 | EUCTR2020-005764-62-DE (EUCTR) | 09/08/2021 | 14/06/2021 | A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 11 | NCT04781543 (ClinicalTrials.gov) | April 1, 2021 | 1/3/2021 | A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis;Sclerosis, Systemic | Drug: HZN-825 BID;Drug: Placebo;Drug: HZN-825 QD | Horizon Therapeutics Ireland DAC | NULL | Recruiting | 18 Years | 75 Years | All | 300 | Phase 2 | United States;Argentina;Austria;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Switzerland;United Kingdom |