Lupus Erythematosus, Cutaneous clinical trials
The registry lists 67 studies for Lupus Erythematosus, Cutaneous across more than 10 countries. 18 are recruiting or about to start. 41 of them are mainly about Lupus Erythematosus, Cutaneous (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-12. Counting its narrower condition Lupus Erythematosus, Discoid too: 87 studies, 20 open.
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Status
Who runs them
Gilead Sciences (4) · EMD Serono Research & Development Institute, Inc. (4) · Biogen (4) · Amgen (3) · University of Pennsylvania (3) · Bristol-Myers Squibb (3) · European Society of Cutaneous Lupus Erythematosus e.V. (2) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (2)
What is being tested here
Drugs under test in Lupus Erythematosus, Cutaneous studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 9, phase 3 first
- Nov 2026A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus · Phase 3 · AstraZeneca
- Dec 2026A 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 · Ventus Therapeutics U.S., Inc.
- Mar 2027Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study · Beijing InnoCare Pharma Tech Co., Ltd.
- Mar 2027The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE · HC Biopharma Inc.
- Mar 2027Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants.. · Xiamen Amoytop Biotech Co., Ltd.
- Apr 2027A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults · Guangdong Hengrui Pharmaceutical Co., Ltd
- Jun 2027A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants · DualityBio Inc.
- Sep 2027Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease · Seismic Therapeutic AU Pty Ltd
- Nov 2027Tapinarof for Cutaneous Lupus Erythematosus · Northwestern University
Who these studies take
Of the 12 Lupus Erythematosus, Cutaneous studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger. 2 (17%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 3 (25%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 1 (8%) | 1 (8%) |
| 18 | 12 (100%) | 12 (100%) |
| 30 | 12 (100%) | 12 (100%) |
| 40 | 12 (100%) | 12 (100%) |
| 50 | 12 (100%) | 12 (100%) |
| 65 | 11 (92%) | 11 (92%) |
| 75 | 9 (75%) | 9 (75%) |
| 85 | 4 (33%) | 4 (33%) |
Across all 67 studies, recruiting or not: 54% stop at 75 or younger and 15% at 65; 3% take children; 1% are for women only and 0% for men only; 18% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
What changed recently
From the registry's own updates since Oct 14, 2026.
Started recruiting2
Newly registered2
- This Study Will Evaluate the Effect and Safety of 626 in Patients With CLEOct 28, 2026NCT07900867
- Study of Afimetoran in Adults With Cutaneous Lupus ErythematosusOct 19, 2026NCT07881120
Studies
Recruiting first, then most recently updated. Showing 50 of 67. Browse all 67 → or search them.
- A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]RecruitingNCT07840287Phase 31 country
- Study of Afimetoran in Adults With Cutaneous Lupus ErythematosusRecruitingNCT07881120Phase 2/31 country
- This Study Will Evaluate the Effect and Safety of 626 in Patients With CLENot yet recruitingNCT07900867Phase 21 country
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic DiseaseRecruitingNCT07332481Phase 320 countries
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)RecruitingNCT07355218Phase 320 countries
- A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy AdultsRecruitingNCT07749651Phase 11 country
- A Study of Quinacrine in Participants With Cutaneous Lupus ErythematosusRecruitingNCT07694336Phase 21 country
- A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusEnrolling by invitationNCT06044337Phase 325 countries
- Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind StudyRecruitingNCT07440537Phase 21 country
- A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE ParticipantsRecruitingNCT06625671Phase 1/22 countries
- Study of S-4321 in Participants With an Autoimmune or Immune-mediated DiseaseRecruitingNCT07455578Phase 11 country
- Tapinarof for Cutaneous Lupus ErythematosusEnrolling by invitationNCT06661213Early Phase 11 country
- Prevalence and Clinical Severity of Cutaneous Lupus ErythematosusRecruitingNCT015100671 country
- Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..Not yet recruitingNCT07408908Phase 1
- The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLENot yet recruitingNCT07306585Phase 11 country
- Research Accelerated by You Lupus RegistryRecruitingNCT069272191 country
- Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus ErythematosusNot yet recruitingNCT06965244Phase 3
- Deep Phenotyping of Cutaneous Lupus ErythematosusRecruitingNCT06411106Not applicable1 country
- A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus ErythematosusActive, not recruitingNCT06015737Phase 332 countries
- 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 ErythematosusActive, not recruitingNCT07260877Phase 28 countries
- A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusActive, not recruitingNCT05531565Phase 2/330 countries
- The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)Active, not recruitingNCT05540327Phase 222 countries
- A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusCompletedNCT05411016Phase 12 countries
- Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy ParticipantsCompletedNCT07072611Early Phase 11 country
- A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)Active, not recruitingNCT06980805Phase 213 countries
- A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.TerminatedNCT05879718Phase 24 countries
- A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of LupusCompletedNCT06013995Phase 18 countries
- Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus ErythematosusTerminatedNCT05591222Phase 211 countries
- Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)TerminatedNCT05629208Phase 23 countries
- The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)CompletedNCT05162586Phase 222 countries
- A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)Active, not recruitingNCT04857034Phase 28 countries
- Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus ErythematosusCompletedNCT04781816Phase 215 countries
- A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisCompletedNCT03817424Phase 13 countries
- Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus ScarsWithdrawnNCT04707924Not applicable1 country
- Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)TerminatedNCT04809623Phase 11 country
- Study of M5049 in CLE and SLE ParticipantsCompletedNCT04647708Phase 16 countries
- Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)CompletedNCT02847598Phase 212 countries
- Low-dose UVA1 Radiation in Cutaneous Lupus PatientsCompletedNCT01776190Not applicable1 country
- A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus ErythematosusCompletedNCT04493541Phase 11 country
- Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)CompletedNCT00633945Not applicable1 country
- Phase Ib Study of SC Milatuzumab in SLECompletedNCT01845740Phase 11 country
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus SubjectsCompletedNCT02927457Phase 11 country
- Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus ErythematosusStatus unknownNCT03260166Phase 21 country
- To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus ErythematosusCompletedNCT01300208Phase 21 country
- Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)CompletedNCT03134222Phase 22 countries
- Autologous Polyclonal Tregs for LupusTerminatedNCT02428309Phase 11 country
- Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus ErythematosusCompletedNCT02656082Phase 21 country
- Cutaneous Lupus Erythematosus and ElidelWithdrawnNCT00222183Not applicable1 country
- Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous PemphigoidTerminatedNCT015591551 country
- Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus ErythematosusCompletedNCT01294774Phase 23 countries