8 recruiting, 4 not yet recruiting, 2 completed, 1 terminated. 6 Phase 2, 4 Phase 3, 3 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Recruiting 4, Not yet recruiting 1, Terminated 1 |
| Phase 3 | 4 | Not yet recruiting 2, Recruiting 2 |
| Phase 1 | 3 | Completed 1, Not yet recruiting 1, Recruiting 1 |
| Not applicable | 1 | Completed 1 |
Follow Cutaneous Lupus Erythematosus (CLE): new trials by email Literature Review of Cutaneous Lupus Erythematosus (CLE) trials Research Report on Cutaneous Lupus Erythematosus (CLE)
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 |
|---|---|---|---|---|---|---|
| This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE Placebo - Cutaneous Lupus Erythematosus (CLE) | Phase 2 | Not yet recruiting | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | 140 | 2026-11-01 | 2026-10-28 |
| 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 |
| Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus Afimetoran, Placebo - Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus | Phase 2 / Phase 3 | Recruiting | Beeline Medicines Corporation | 390 | 2026-10-01 | 2026-10-29 |
| 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 |
| 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 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 |
| 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 |
| Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) Edecesertib, Edecesertib Placebo - Cutaneous Lupus Erythematosus (CLE) | Phase 2 | Terminated | Gilead Sciences | 20 | 2023-04-17 | 2026-02-17 |
| A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus Placebo, KK4277 - Healthy Volunteers, Systemic Lupus Erythematosus (SLE) | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 125 | 2022-08-03 | 2026-09-29 |
| Research Accelerated by You Lupus Registry Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN) | Recruiting | Lupus Foundation of America | 10000 | 2020-10-01 | 2026-01-23 | |
| Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE) Lenalidomide - Cutaneous Lupus Erythematosus (CLE) | Not applicable | Completed | University of Pennsylvania | 5 | 2007-11-01 | 2023-02-09 |
| Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus Cutaneous Lupus Erythematosus (CLE) | Recruiting | University of Pennsylvania | 700 | 2006-12-01 | 2026-03-30 |
Lupus Erythematosus, Cutaneous (15) · Lupus Erythematosus, Systemic (7) · Lupus Erythematosus, Discoid (3) · Arthritis, Psoriatic (1) · Arthritis, Rheumatoid (1) · Autoimmune Diseases (1) · Dermatitis, Atopic (1) · Lupus Nephritis (1) · Psoriasis (1)
Connective Tissue Diseases (15) · Skin Diseases (15) · Skin and Connective Tissue Diseases (15) · Immune System Diseases (8) · Autoimmune Diseases (7) · Arthritis (1) · Bone Diseases (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Dermatitis (1) · Female Urogenital Diseases (1) · Female Urogenital Diseases and Pregnancy Complications (1) · Genetic Diseases, Inborn (1) · Glomerulonephritis (1) · Hypersensitivity (1) · Hypersensitivity, Immediate (1)
Lenalidomide (2) · Methotrexate (1) · Quinacrine (1) · Standard of Care (1)
EMD Serono Research & Development Institute, Inc. (2) · University of Pennsylvania (2) · Assistance Publique - Hôpitaux de Paris (1) · Beeline Medicines Corporation (1) · Beijing InnoCare Pharma Tech Co., Ltd. (1) · Gilead Sciences (1) · HC Biopharma Inc. (1) · Kyowa Kirin Co., Ltd. (1) · Lupus Foundation of America (1) · Seismic Therapeutic AU Pty Ltd (1) · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (1) · Ventus Therapeutics U.S., Inc. (1) · Victoria Werth (1)
United States (9) · China (3) · Germany (3) · Spain (3) · Australia (2) · Bulgaria (2) · France (2) · Japan (2) · Poland (2) · South Korea (2) · Brazil (1) · Georgia (1) · Hungary (1) · Israel (1) · Italy (1)
Victoria P Werth, MD (2) · Jennifer Martin, MD (1) · Joy N Buie, PhD, MSCR, RN (1) · Jun Kinoshita (1) · Victoria Werth, M.D. (1)
2025 (1)