Cenerimod ( DrugBank: Cenerimod )


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14

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
1NCT05672576
(ClinicalTrials.gov)
January 16, 20233/1/2023A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background TherapyLupus Erythematosus, SystemicDrug: Cenerimod;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLRecruiting18 Years75 YearsAll420Phase 3United States
2NCT05648500
(ClinicalTrials.gov)
December 13, 20225/12/2022A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background TherapyLupus Erythematosus, SystemicDrug: Cenerimod;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLRecruiting18 Years75 YearsAll420Phase 3United States
3JPRN-jRCT2011210019
06/11/202130/06/2021Phase 2 double blind study of cenerimodA randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE) Systemic lupus erythematosusAdministration of two doses of cenerimod (2 and 4 mg) given orally once daily for 3 months in adult subjects with moderate to severe SLE concurrently receiving SLE background treatmentYokoyama YoshinariNULLNot Recruiting>= 18age old<= 75age oldBoth16Phase 2Japan
4EUCTR2018-001808-11-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
5EUCTR2018-001808-11-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
6EUCTR2018-001808-11-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
7EUCTR2018-001808-11-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
8EUCTR2018-001808-11-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
9EUCTR2018-001808-11-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
10EUCTR2018-001808-11-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
11EUCTR2018-001808-11-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
12NCT03742037
(ClinicalTrials.gov)
December 21, 201812/11/2018Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA 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)Systemic Lupus ErythematosusDrug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLCompleted18 Years75 YearsAll427Phase 2United States;Bulgaria;Chile;Czechia;France;Georgia;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Germany;Lithuania
13EUCTR2018-001808-11-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
14NCT02472795
(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