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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A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO)

CATEGORIES: General SLE

CATEGORIES: General SLE

The purpose of this 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.

To Learn More Contact:
Contact: UCB Cares  +1844599 ext 2273  UCBCares@ucb.com
ClinicalTrials.gov Identifer: NCT04294667

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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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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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