M5049 ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 49 | Systemic lupus erythematosus | 5 |
49. Systemic lupus erythematosus
Clinical trials : 993 / Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
| 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 | NCT05540327 (ClinicalTrials.gov) | September 16, 2022 | 12/9/2022 | The 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 Erythematosus | Drug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: Placebo | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 76 Years | All | 440 | Phase 2 | United 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 |
| 2 | NCT05162586 (ClinicalTrials.gov) | March 31, 2022 | 8/12/2021 | The 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 Erythematosus | Drug: Enpatoran low dose;Drug: Enpatoran medium dose;Drug: Enpatoran high dose;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | 75 Years | All | 440 | Phase 2 | United States;Argentina;Australia;Bulgaria;Chile;China;Colombia;Greece;Japan;Korea, Republic of;Mauritius;Mexico;Moldova, Republic of;Philippines;Poland;South Africa;Spain;Taiwan;Germany |
| 3 | EUCTR2021-004648-27-ES (EUCTR) | 21/03/2022 | 19/11/2021 | A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus Erythematosus | A 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 2 | United 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 | ||
| 4 | EUCTR2021-004648-27-BG (EUCTR) | 24/02/2022 | 12/01/2022 | A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus | A 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 2 | United 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 | ||
| 5 | NCT04647708 (ClinicalTrials.gov) | December 16, 2020 | 23/11/2020 | Study of M5049 in CLE and SLE Participants | A 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 Care | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus | Drug: M5049;Drug: Placebo | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 1 | Bulgaria;Germany;Moldova, Republic of;North Macedonia;Spain;Ukraine |