ACT-334441 ( 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11

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001808-11-GR
(EUCTR)
29/07/202016/07/2020A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
2EUCTR2018-001808-11-DE
(EUCTR)
04/10/201918/10/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
3EUCTR2018-001808-11-PL
(EUCTR)
17/05/201915/05/2019A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2Georgia;Germany;Romania;Bulgaria;United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland
4EUCTR2018-001808-11-BG
(EUCTR)
20/03/201906/12/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany
5EUCTR2018-001808-11-HU
(EUCTR)
08/02/201922/11/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
6EUCTR2018-001808-11-IT
(EUCTR)
07/02/201928/01/2021A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE:Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
IDORSIA PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
7EUCTR2018-001808-11-ES
(EUCTR)
24/01/201916/11/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
8EUCTR2018-001808-11-FR
(EUCTR)
14/01/201931/08/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
9EUCTR2018-001808-11-GB
(EUCTR)
17/12/201817/09/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;Georgia;Bulgaria;Germany
10EUCTR2014-002984-14-BG
(EUCTR)
05/06/201511/05/2015International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupusA multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. - Systemic lupus erythematosus
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACT-334441
Other descriptive name: ACT-334441
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria
11NCT02472795
(ClinicalTrials.gov)
June 1, 201514/5/2015Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Matching placebo;Drug: CenerimodIdorsia Pharmaceuticals Ltd.NULLCompleted18 Years65 YearsAll105Phase 1/Phase 2United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine