ALPN-101 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス5

49. 全身性エリテマトーデス


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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2020-004047-86-HU
(EUCTR)
28/02/202223/12/2021A Study of ALPN-101 in Active LupusA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2France;United States;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of
2EUCTR2020-004047-86-ES
(EUCTR)
11/08/202123/06/2021A Study of ALPN-101 in Active LupusA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2France;United States;Poland;Spain;Russian Federation;Germany;Korea, Republic of
3EUCTR2020-004047-86-PL
(EUCTR)
14/07/202109/06/2021A Study of ALPN-101 in Active LupusA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of
4NCT04835441
(ClinicalTrials.gov)
June 22, 20215/4/2021ALPN-101 in Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: ALPN-101;Drug: PlaceboAlpine Immune Sciences, Inc.NULLRecruiting18 Years65 YearsAll130Phase 2United States;Korea, Republic of;Poland
5EUCTR2020-004047-86-FR
(EUCTR)
04/06/2021A Study of ALPN-101 in Active LupusA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Spain;Poland;Russian Federation;Germany;Korea, Republic of