49. Systemic lupus erythematosus Clinical trials / Disease details


Clinical trials : 993 Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200

  
5 trials found
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1NCT05540327
(ClinicalTrials.gov)
September 16, 202212/9/2022The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)Systemic Lupus ErythematosusDrug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years76 YearsAll440Phase 2United States;Bulgaria;Japan;Moldova, Republic of;Poland;Argentina;Australia;Brazil;Chile;China;Colombia;Greece;Israel;Korea, Republic of;Mauritius;Mexico;Philippines;Serbia;South Africa;Spain;Taiwan
2NCT05162586
(ClinicalTrials.gov)
March 31, 20228/12/2021The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)Systemic Lupus ErythematosusDrug: Enpatoran low dose;Drug: Enpatoran medium dose;Drug: Enpatoran high dose;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 Years75 YearsAll440Phase 2United States;Argentina;Australia;Bulgaria;Chile;China;Colombia;Greece;Japan;Korea, Republic of;Mauritius;Mexico;Moldova, Republic of;Philippines;Poland;South Africa;Spain;Taiwan;Germany
3EUCTR2021-004648-27-ES
(EUCTR)
21/03/202219/11/2021A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;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;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;Bulgaria;South Africa;China;Japan;Moldova, Republic of
4EUCTR2021-004648-27-BG
(EUCTR)
24/02/202212/01/2022A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;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;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;South Africa;Bulgaria;China;Japan;Moldova, Republic of
5NCT04647708
(ClinicalTrials.gov)
December 16, 202023/11/2020Study of M5049 in CLE and SLE ParticipantsA Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of CareSystemic Lupus Erythematosus;Cutaneous Lupus ErythematosusDrug: M5049;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years65 YearsAll44Phase 1Bulgaria;Germany;Moldova, Republic of;North Macedonia;Spain;Ukraine