Clinical trials: Cutaneous Lupus
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 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, 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.
Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE).
- Trial name
- NCT04857034
- Testing
- Deucravacitinib
- Where
- 41 sites in United States, Argentina and 6 more
- Volunteers
- 74 people
- Sponsor
- Bristol-Myers Squibb
Cutaneous Lupus Erythematosus
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Primary Objective: Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)…
- Trial name
- CLEan (NCT04781816)
- Testing
- SAR443122
- Where
- 50 sites in United States, Argentina and 13 more
- Volunteers
- 78 people
- Sponsor
- Sanofi
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
Cutaneous Lupus Erythematosus
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).
- Trial name
- LYNX (NCT04809623)
- Testing
- Edecesertib, Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- Gilead Sciences
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
Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement…
- Trial name
- LILAC (NCT02847598)
- Testing
- BIIB059 (litifilimab)
- Where
- 128 sites in United States, Argentina and 10 more
- Volunteers
- 264 people
- Sponsor
- Biogen
Lupus Erythematosus, Cutaneous
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
- Trial name
- NCT04493541
- Testing
- BMS-986256
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
Phase Ib Study of SC Milatuzumab in SLE
Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System
- Trial name
- NCT01845740
- Testing
- milatuzumab
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Gilead Sciences
Lupus Erythematosus, Cutaneous
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects
This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and…
- Trial name
- NCT02927457
- Testing
- GSK2646264 1%
- Where
- 5 sites in Germany
- Volunteers
- 11 people
- Sponsor
- GlaxoSmithKline
Cutaneous Lupus Erythematosus
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
- Trial name
- NCT01300208
- Testing
- CC-11050
- Where
- 19 sites in United States
- Volunteers
- 48 people
- Sponsor
- Amgen
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