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The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

CATEGORIES: General SLE | Skin

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 6151 72 5200 or email at service@emdgroup.com.

ClinicalTrials.gov identifier (NCT number): NCT05162586

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)

First filed November 17, 2022; Updated January 26, 2023; Recruiting

CATEGORIES: General SLE

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 the NCT number and the number of the trial site.

ClinicalTrials.gov identifier (NCT number): NCT05620407

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A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

First posted November 15, 2022; Updated January 26, 2023. Recruiting

CATEGORIES: General SLE

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 number and the number of the trial site.

ClinicalTrials.gov identifier (NCT number): NCT05617677

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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

First posted September 8, 2022, Updated September 19, 2022; Recruiting

CATEGORIES: General SLE

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 participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.

The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

To Learn More Contact

In the US, call US Biogen Clinical Trial Center at 866-633-4636 or by email to clinicaltrials@biogen.com

ClinicalTrials.gov identifier (NCT number): NCT05531565

A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus

CATEGORIES: General SLE

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 More Contact

Study Director at 1-877-CTLILLY or 1-317-615-4559 M-F 9 AM – 5 PM Eastern Time

ClinicalTrials.gov identifier (NCT number): NCT0513586

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

April 1, 2022

CATEGORIES: General SLE

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

ELEVATE – (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation) (ELEVATE)

CATEGORIES: General SLE

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 Gupta at 323, 489-4220 or support@theelevatestudy.com

Carmelita Kiefer at 323-489-4220 or support@theelevatestudy.com

ClinicalTrials.gov identifier (NCT number): NCT05347992

 

 

 

PRV-3279-2a Trial in Systemic Lupus (PREVAIL-2)

CATEGORIES: General SLE

First posted October, 2021, Updated January, 2022; Recruiting
CATEGORIES: Lupus

The purpose of this Phase 2a PREVAIL-2 trial is to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) patients with active disease after amelioration induced by corticosteroid treatment.

To Learn More Contact

Clinical Operations at 857-675-1664 or email info@proventionbio.com

Chief Medical Officer at 908-356-0514 or email info@proventionbio.com

ClinicalTrials.gov identifier (NCT number): NCT05087628

A novel Phase 2 double-blind, randomized, controlled clinical trial to evaluate the efficacy of centrally acting, non-toxic ACE inhibition in cognitive impairment associated with SLE

CATEGORIES: General SLE

First posted July, 2020, Updated November, 2021; Recruiting
CATEGORIES: CNS Lupus

This research study is being done to test the effects of centrally-acting ACE inhibitor, named lisinopril, on resting metabolism in the brain and on cognitive function. The investigators will see if Lisinopril will decrease resting metabolism in the brain and improve cognitive function (memory and concentration) compared to a non-centrally acting ACE inhibitor called benazepril.

To Learn More Contact
Contact: Andrew Shaw at 516-562-2591 or anshaw@northwell.edu
ClinicalTrials.gov identifier: NCT04486118

The study is sponsored by Northwell Health in collaboration with the Lupus Research Alliance.

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

CATEGORIES: General SLE

First filed December 23, 2020, Updated July 2022; Recruiting
CATEGORIES: General SLE

The purpose of this  Phase 2 study is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active SLE.

This study is being offered at 20 LuCIN sites – institutions that are members of the Lupus Clinical Investigators Network managed by Lupus Therapeutics, an affiliate of the Lupus Research Alliance.

To Learn More Contact
Amgen Call Center at 866-572-6436 or email medinfo@amgen.com

ClinicalTrials.gov identifier (NCT number): NCT04680637

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