Clinical trials: Cutaneous Lupus
Cutaneous Lupus Erythematosus
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
- Trial name
- LAVENDER (NCT06015737)
- Testing
- Anifrolumab
- Where
- 188 sites in United States, Argentina and 30 more
- Volunteers
- 339 people
- Sponsor
- AstraZeneca
Atopic Dermatitis, Psoriasis
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable.
- Conditions
- Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa, Lichen Planus
- Trial name
- ImmuneSkinBank (NCT06599411)
- Testing
- Sampling
- Where
- France
- Volunteers
- 830 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
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 (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.
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
Lupus
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection…
- Trial name
- NCT06013995
- Testing
- BMS-986326
- Where
- 20 sites in United States, Argentina and 6 more
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
Discoid Lupus Erythematosus
Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to…
- Trial name
- NCT05591222
- Testing
- Daxdilimab
- Where
- 68 sites in United States, Argentina and 9 more
- Volunteers
- 72 people
- Sponsor
- Amgen
Cutaneous Lupus
Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient…
- Trial name
- ADlupus (NCT06506214)
- Testing
- Questionnaires
- Where
- 4 sites in France
- Volunteers
- 202 people
- Sponsor
- University Hospital, Toulouse
Cutaneous Lupus Erythematosus
Tapinarof for Cutaneous Lupus Erythematosus
The investigators hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to…
- Trial name
- NCT06661213
- Testing
- Tapinarof
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Northwestern University
Cutaneous Lupus Erythematosus (CLE)
Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).
- Trial name
- NCT01510067
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- University of Pennsylvania
Cutaneous Lupus, Systemic Lupus Erythematosus
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-45…
- Trial name
- NCT03288324
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in…
- Trial name
- NCT07408908
- Testing
- ACT100 Injection
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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 (SLE), Lupus Nephritis (LN)
Research Accelerated by You Lupus Registry
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- RAY (NCT06927219)
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Lupus Foundation of America
Systemic Lupus Erythematosus, Cutaneous Lupus
Duke Lupus Registry
Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.
- Trial name
- NCT00512694
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Duke University
Autoimmune Diseases, Pregnancy Related
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases. The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and…
- Conditions
- Autoimmune Diseases, Pregnancy Related, Systemic Lupus Erythematosus, Cutaneous Lupus
- Trial name
- MADRA (NCT03276923)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, 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.