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

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

CATEGORIES: General SLE

First filed August, 2019, updated January, 2021
CATEGORIES: General SLE

This phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study is investigating AMG 570 in subjects with active SLE who have had inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators.

This study is being offered at 24 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
Click Here to Visit AmgenTrials
Clinicaltrials.gov Identifier: NCT04058028

24 LuCIN sites (U.S. and Canada)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

CATEGORIES: General SLE

First filed March 2020, Updated January 2021; Recruiting
CATEGORIES: General SLE

The purpose of this Phase 3 study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

This study is being offered at 34 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
Call UCB Cares +1844599 ext 2273 or UCBCares&ucb.com.
ClinicalTrials.gov identifier (NCT number):NCT04294667 

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A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)

First filed August 2018, Updated Oct. 2020 - Active, Not Recruiting

CATEGORIES: General SLE

The reason for this randomized, double-blind, placebo-controlled, parallel-group, phase 3 study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

To Learn More Contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST)Eli Lilly and Company
ClinicalTrials.gov identifier: NCT03616912

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Role of PPAR-y Anonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)

First filed January 2015, updated Oct. 2020 - Completed

CATEGORIES: General SLE

This Phase 1/2 randomized study sponsored by the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is looking at how well pioglitazone improves blood vessel function and decreases blood vessel inflammation for patients with lupus. The study is being conducted at the NIH Clinical Center in Bethesda, Maryland.

To Learn More Contact
Call 800-411-1222 ext or prpl@mail.cc.nih.gov
ClinicalTrials.gov identifier: NCT02338999

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A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

first filed January 2016, updated Oct. 2020 - Completed

CATEGORIES: General SLE

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus. The trial is sponsored by Resolve Therapeutics.

To Learn More Contact
James Posada, Ph.D. at 208 727 7010 or jp@resolvebio.com
ClinicalTrials.gov identifier: NCT02660944

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A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Active Systemic Lupus Erythematosus (SLE)

First filed November 2016, updated Aug. 2020 - Completed

CATEGORIES: General SLE

The goal of this multicenter, randomized, double blind, placebo controlled study is to assess the efficacy and safety of H.P. Acthar® Gel in people with persistently active Systemic Lupus Erythematosus despite moderate dose corticosteroids.

To Learn More Contact
George Omburo, PhD at 908-238-6786 or george.omburo@mallinckrodt.com
ClinicalTrials.gov identifier: NCT02953821

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Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) (LILAC)

First filed June 2016, updated November 2018

CATEGORIES: General SLE

The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing skin disease activity in participants with systemic lupus erythematosus (SLE) (Part A), and in participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations (Part B), and to investigate the dose response relationship in participants with active SLE and skin manifestations (Part A only). Secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE disease activity. Study sponsor: Biogen

To Learn More Contact
Biogen at clinicaltrials@biogen.com
ClinicalTrials.gov identifier: NCT02847598

A Phase II Study of M2951 in Systemic Lupus Erythematosus

first filed November 2016, updated Aug. 2020 - Terminated

CATEGORIES: General SLE

The purpose of the study is to assess the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE). M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders.

To Learn More Contact
US Medical Information at 888-275-7376
ClinicalTrials.gov identifier: NCT02975336

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A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

first filed May 2017, updated March 2020 - Active, Not Recruiting

CATEGORIES: General SLE

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus.

First Posted May, 2017. Last Updated August, 2021

Study Status: Active, Not Recruiting

To Learn More Contact
Associate Director Clinical Trial Disclosure at 1-888-260-1599 or clinicaltrialdisclosure@celgene.com
ClinicalTrials.gov identifier: NCT03161483

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