39 completed, 13 terminated, 11 recruiting, 6 not yet recruiting. 39 Phase 2, 18 Phase 1, 10 Phase 3, 8 Not applicable, 5 Early Phase 1.
Follow Lupus Erythematosus, Cutaneous: new trials by email Literature Review of Lupus Erythematosus, Cutaneous trials Research Report on Lupus Erythematosus, Cutaneous
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE] Enpatoran - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Not yet recruiting | EMD Serono Research & Development Institute, Inc. | 404 | 2026-10-15 | 2026-09-25 |
| Phase 2/3 Double-Blind, Placebo-Controlled Study of Afimetoran in Cutaneous Lupus Erythematosus Afimetoran, Placebo - Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus | Phase 2 / Phase 3 | Not yet recruiting | Beeline Medicines Corporation | 390 | 2026-10-01 | 2026-10-19 |
| A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults SHR-7012 injection ; placebo, SHR-7012 injection ; placebo ; - Cutaneous Lupus Erythematosus(CLE) | Phase 1 | Recruiting | Guangdong Hengrui Pharmaceutical Co., Ltd | 50 | 2026-08-19 | 2026-08-31 |
| A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus Quinacrine Hydrochloride, Placebo - Cutaneous Lupus Erythematosus (CLE) | Phase 2 | Recruiting | Victoria Werth | 24 | 2026-06-30 | 2026-08-12 |
| Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease S-4321 - Autoimmune Diseases, Rheumatoid Arthritis (RA) | Phase 1 | Recruiting | Seismic Therapeutic AU Pty Ltd | 24 | 2026-06-01 | 2026-06-01 |
| A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus Dihydroartemisinin tablets, Hydroxychloroquine tablets - Discoid Lupus Erythematosus | Phase 2 | Not yet recruiting | Kunming Pharmaceuticals, Inc. | 100 | 2026-04-30 | 2026-04-30 |
| Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study ICP-488 Tablets, ICP-488 Placebo - Cutaneous Lupus Erythematosus (CLE) | Phase 2 | Recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 105 | 2026-04-27 | 2026-06-08 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) Enpatoran, Placebo, Standard of care (SoC) - Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-04-01 | 2026-10-06 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease Enpatoran, Placebo, Standard of care (SoC) - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-03-10 | 2026-10-06 |
| Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants.. ACT100 Injection, Placebo for ACT100 - Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus | Phase 1 | Not yet recruiting | Xiamen Amoytop Biotech Co., Ltd. | 48 | 2026-03-06 | 2026-02-13 |
| The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE HC022, Placebo - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 1 | Not yet recruiting | HC Biopharma Inc. | 32 | 2025-12-30 | 2026-01-28 |
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus VENT-03, Placebo - Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus | Phase 2 | Recruiting | Ventus Therapeutics U.S., Inc. | 24 | 2025-12-03 | 2026-10-05 |
| Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus Lenalidomide, Methotrexate (MTX) - Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 122 | 2025-10-01 | 2025-05-11 |
| Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants SOF-SKN 0.25%, SOF-SKN 0.5%, SOF-SKN 1% - Cutaneous Lupus Erythematosus | Early Phase 1 | Completed | Noxopharm Limited | 24 | 2025-07-14 | 2026-09-02 |
| Tapinarof for Cutaneous Lupus Erythematosus Tapinarof - Cutaneous Lupus Erythematosus | Early Phase 1 | Enrolling by invitation | Northwestern University | 10 | 2025-04-03 | 2026-04-29 |
| A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) IMVT-1402, Placebo - Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | Phase 2 | Active not recruiting | Immunovant Sciences GmbH | 56 | 2025-02-19 | 2026-08-28 |
| A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants DB-2304, Placebo, Prednisone - Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 148 | 2024-10-04 | 2026-06-02 |
| A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Anifrolumab, Placebo - Cutaneous Lupus Erythematosus | Phase 3 | Active not recruiting | AstraZeneca | 339 | 2024-06-29 | 2026-07-29 |
| Deep Phenotyping of Cutaneous Lupus Erythematosus IMIQUIMOD cream 50mg/g - Cutaneous Lupus Erythematosus | Not applicable | Unknown | Centre for Human Drug Research, Netherlands | 40 | 2024-06-01 | 2024-05-13 |
| Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus Ruxolitinib 1.5% cream, Application without occlusion in Area 1, Application under occlusion at night in Area 2 - Discoid Lupus Erythematosus | Phase 2 | Recruiting | Innovaderm Research Inc. | 20 | 2024-04-19 | 2025-03-24 |
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Lupus Erythematosus, Discoid (42) · Lupus Erythematosus, Systemic (27) · Autoimmune Diseases (2) · Dermatitis, Atopic (2) · Lupus Nephritis (2) · Alopecia (1) · Arthritis, Psoriatic (1) · Arthritis, Rheumatoid (1) · Connective Tissue Diseases (1) · Dermatomyositis (1) · Immune System Diseases (1) · Lichen Planus (1) · Lupus Vasculitis, Central Nervous System (1) · Pemphigoid, Bullous (1)
Skin and Connective Tissue Diseases (85) · Connective Tissue Diseases (84) · Skin Diseases (84) · Immune System Diseases (30) · Autoimmune Diseases (27) · Arthritis (2) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Dermatitis (2) · Female Urogenital Diseases (2) · Female Urogenital Diseases and Pregnancy Complications (2) · Genetic Diseases, Inborn (2) · Glomerulonephritis (2) · Hypersensitivity (2) · Hypersensitivity, Immediate (2)
Standard of Care (3) · Blood Specimen Collection (2) · Etanercept (2) · Lenalidomide (2) · Niacinamide (2) · Urine Specimen Collection (2) · pimecrolimus (2) · ruxolitinib (2) · 4-(9-(tetrahydrofuran-3-yl))-8-(2,4,6-trifluorophenylamino)-9H-purin-2-ylaminocyclohexan-1-ol (1) · Alitretinoin (1) · Betamethasone Valerate (1) · CC-11050 (1) · Dimethyl Fumarate (1) · Fumarates (1) · GLPG0634 (1)
Amgen (4) · Biogen (4) · EMD Serono Research & Development Institute, Inc. (4) · Gilead Sciences (4) · Bristol-Myers Squibb (3) · University of Pennsylvania (3) · Astion Pharma A/S (2) · European Society of Cutaneous Lupus Erythematosus e.V. (2) · Heinrich-Heine University, Duesseldorf (2) · Janssen Research & Development, LLC (2) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (2) · Northwestern University (2) · Pfizer (2) · University Hospital Muenster (2) · Al-Azhar University (1)
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Annegret Kuhn, MD (5) · Annegret Kuhn, Prof. Dr. (2) · Victoria P Werth, MD (2) · Ahmed Hassan Nouh, MD (1) · Amy McMichael, MD (1) · Andrew G Franks, Jr., MD (1) · Anna Haemel, MD (1) · Behrooz Barikbin, M.D. (1)
PMID 33687069, PMID 23896980, PMID 24528907, PMID 26376111, PMID 28118537, PMID 32335844, PMID 33336508, PMID 34498056, PMID 35390178, PMID 35939578, PMID 36069871, PMID 37148249, PMID 41136221, PMID 42107374, PMID 42107375
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