Clinical trials: Cutaneous Lupus Erythematosus (CLE)
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects.
- Trial name
- NCT07306585
- Testing
- HC022
- Where
- China
- Volunteers
- 32 people
- Sponsor
- HC Biopharma Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
- Trial name
- NCT06980805
- Testing
- IMVT-1402
- Where
- 86 sites in United States, Argentina and 11 more
- Volunteers
- 56 people
- Sponsor
- Immunovant Sciences GmbH
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
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
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE).
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus)
- Trial name
- AERIS (NCT07260877)
- Testing
- VENT-03
- Where
- 34 sites in United States, Bulgaria and 6 more
- Volunteers
- 24 people
- Sponsor
- Ventus Therapeutics U.S., Inc.
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- ELOWEN-1 (NCT07332481)
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Study of M5049 in CLE and SLE Participants
This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).
- Trial name
- NCT04647708
- Testing
- M5049
- Where
- 12 sites in Bulgaria, Germany and 4 more
- Volunteers
- 25 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cutaneous Lupus Erythematosus (CLE)
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
- Trial name
- NCT07440537
- Testing
- ICP-488 Tablets
- Where
- 27 sites in China
- Volunteers
- 105 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cutaneous Lupus Erythematosus
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
- Trial name
- NCT03134222
- Testing
- Lanraplenib, Filgotinib
- Where
- 16 sites in United States, Canada
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Trial name
- NCT06625671
- Testing
- DB-2304, Prednisone
- Where
- 7 sites in United States, Australia
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- DualityBio Inc.
Cutaneous Lupus Erythematosus (CLE)
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE.
- Trial name
- COSMIC (NCT05629208)
- Testing
- Edecesertib
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Cutaneous Lupus Erythematosus
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated.
- Trial name
- NCT01470313
- Testing
- PD-0360324
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Pfizer
Autoimmune Diseases, Rheumatoid Arthritis (RA)
Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease
This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in…
- Conditions
- Autoimmune Diseases, Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Psoriasis (PsO)
- Trial name
- NCT07455578
- Testing
- S-4321
- Where
- 2 sites in Australia
- Volunteers
- 24 people
- Sponsor
- Seismic Therapeutic AU Pty Ltd
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Phase 2/3 Double-Blind, Placebo-Controlled Study of Afimetoran in Cutaneous Lupus Erythematosus
This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or…
- Trial name
- DISCOVERY (NCT07881120)
- Testing
- Afimetoran
- Volunteers
- 390 people
- Sponsor
- Beeline Medicines Corporation
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
- Trial name
- NCT05879718
- Testing
- PF-06823859
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 8 people
- Sponsor
- Pfizer
Healthy Volunteers, Systemic Lupus Erythematosus (SLE)
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- NCT05411016
- Testing
- KK4277
- Where
- 23 sites in Japan, South Korea
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST (NCT05531565)
- Testing
- Litifilimab
- Where
- 315 sites in United States, Argentina and 28 more
- Volunteers
- 450 people
- Sponsor
- Biogen
Cutaneous Lupus Erythematosus(CLE)
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
- Trial name
- NCT07749651
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd