49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2020-004047-86-HU (EUCTR) | 28/02/2022 | 23/12/2021 | A Study of ALPN-101 in Active Lupus | A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 2 | EUCTR2020-004047-86-ES (EUCTR) | 11/08/2021 | 23/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Poland;Spain;Russian Federation;Germany;Korea, Republic of | ||
| 3 | EUCTR2020-004047-86-PL (EUCTR) | 14/07/2021 | 09/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 4 | NCT04835441 (ClinicalTrials.gov) | June 22, 2021 | 5/4/2021 | ALPN-101 in Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: ALPN-101;Drug: Placebo | Alpine Immune Sciences, Inc. | NULL | Recruiting | 18 Years | 65 Years | All | 130 | Phase 2 | United States;Korea, Republic of;Poland |
| 5 | EUCTR2020-004047-86-FR (EUCTR) | 04/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Spain;Poland;Russian Federation;Germany;Korea, Republic of |