LupusTrials.org This Phase II, randomized, double-blind, placebo-controlled dose-ranging, parallel and adaptive study aims to evaluate the efficacy and safety of enpatoran in SLE and in CLE (SCLE and/or DLE) participants receiving standard of care (WILLOW). To Learn More Contact: EMD Serono US Medical Information at 888-275-7376 or email at eMediUSA@emdserono.com Communications Center by phone at +49 …
Archives: Trials
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
The Phase 3 study will assess atacicept vs. placebo on the impact of renal (kidney) function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period. To Learn More …
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2) (POETYK SLE-2)
The purpose of this Phase 3 study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. To Learn More Contact: The BMS Study Connect Contact Center at www.BMSStudyConnect.com or call 855-907-3286 or email Clinical.Trials@bms.com. First line of the email must contain …
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
The purpose of this Phase 3 study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. To Learn More Contact BMS Study Connect Contact Center www.BMSStudyConnect.com or call 855-907-3286 or email Clinical.Trials@bms.com. First line of the email must contain the NCT …
A Study to Assess the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
The primary objectives of the study are to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in …
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
CATEGORIES: General SLE First posted November 17, 2021, Updated September 9, 2022; Recruiting The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits. To Learn …
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis
September 16, 2022 CATEGORIES: Lupus Nephritis First posted September 15, 2022, Updated September 15, 2022 This trial aims to learn about the safety and tolerability of daxdilimab (trial drug), and to learn about the effect it has on lupus nephritis when combined with standard treatment (that is, mycophenolate mofetil [MMF] or mycophenolic acid [MPA] and …
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus
CATEGORIES: General SLE First posted April 1, 2022, Updated July 11, 2022; Recruiting The purpose of this Phase 3 study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE. To Learn More Contact Call RemeGen at 301-284-1015 or by email to RC18_SLEstudy@remegenbio.com ClinicalTrials.gov identifier (NCT number): NCT05306574 …
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (IRIS)
CATEGORIES: Lupus Nephritis First posted November 30, 2021, Updated August 10, 2022; Recruiting This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or …
ELEVATE – (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation) (ELEVATE)
First posted April 27, 2022, Updated May 5, 2022; Recruiting CATEGORIES: General SLE The purpose of this large observational trial is to explore the potential for use of DxTerity’s AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information To Learn More Contact Deepti Sood …