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

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis

CATEGORIES: 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 corticosteroids [also called steroids, which are a type of anti-inflammatory drugs]) when compared to combination of placebo and standard treatment.

To Learn More Contact

Call Horizon Therapeutics at 1-866-479-6742 or by email to clinicaltrials@horizontherapeutics.com

ClinicalTrials.gov identifier (NCT number): NCT05540665

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

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (IRIS)

CATEGORIES: Lupus Nephritis

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 without concomitant Class V).

To Learn More

Contact: AstraZeneca Clinical Study Information at 1-877-240-9479 or information.center@astrazeneca.com

ClinicalTrials.gov identifier (NCT number): NCT05138133

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.

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

CATEGORIES: Lupus Nephritis

First posted September, 2020, Updated September, 2021; Recruiting
CATEGORIES: Lupus Nephritis

The objectives of this Phase 2, Double-Blind, Randomized, Placebo-Controlled Study is to evaluate the efficacy and safety of ravulizumab in adult participants With proliferative lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN)

To Learn More Contact
Contact: Alexion Pharmaceuticals, Inc.at 855-752-2356 or clinicaltrials@alexion.com
ClinicalTrials.gov identifier: NCT04564339

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 Phase 2 of VIB7734 for the Treatment of Moderate to Severely Active SLE (RECAST SLE)

First filed June, 2021, Updated June, 2021; Recruiting
CATEGORIES: General SLE

The purpose of this  Phase 2 randomized, double-blind, placebo-controlled study is to study the safety and efficacy of VIB7734 for the treatment of moderate to severely active Systemic Lupus Erythematosus in approximately 195 participants.

This study is being offered at 7 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
Horizon Therapeutics1-866-479-6742 or visit clinicaltrials@horizontherapeutics.com
ClinicalTrials.gov identifier (NCT number): NCT04925934

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COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

CATEGORIES: General SLE

This randomized, multi-site, adaptive, open-label clinical trial will compare the immune response to different COVID-19 vaccine booster doses in participants with autoimmune disease requiring immunosuppressive medications.

To Learn More Contact
Judith A. James, MD, PhD, Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation
Meggan C. Mackay, MD, MS, Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research
ClinicalTrials.gov identifier: NCT05000216

Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

CATEGORIES: Lupus Nephritis

A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care (TOPAZ-1

First filed May 2021; Recruiting

The primary objective of this Phase 3 randomized, double-blind, placebo-controlled study is to test the efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.

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

US Biogen Clinical Trial Center at 866-633-4636 or by email at clinicaltrials@biogen.com
Global Biogen Clinical Trial Center by email at clinicaltrials@biogen.com
ClinicalTrials.gov identifier: NCT04895241

Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis (EQUALISE)

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis.

To Learn More Contact:
Study Contact: Catherine Kim, 858 412 5302 or clinicaltrials@equilliumbio.com
ClinicalTrials.gov Identifer: NCT04128579

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

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

CATEGORIES: Lupus Nephritis

CATEGORIES: Lupus Nephritis

The purpose of this study is to determine if AMG 570 could be a useful therapeutic agent in the current treatment landscape where subjects with systemic lupus erythematosus (SLE) have ongoing disease activity despite treatment with standard of care therapies.

To Learn More Contact
Reference Study ID Number: CA41705 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
global.rochegenentechtrials@roche.com
ClinicalTrials.gov identifier: NCT04221477

JBT-101 in Systemic Lupus Erythematosus (SLE)

The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE).

To Learn More Contact
Visit ClinicalTrials.gov to search for sites near you and reach out to Contact listed.
ClinicalTrials.gov identifier: NCT03093402

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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Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS) (PROMISSE)

First filed Sept. 2005, updated July 2020 - Recruiting

CATEGORIES: Pregnancy

The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The data obtained will be analyzed and used to explore mechanisms and predictors of poor fetal outcome.

To Learn More Contact
Marta M. Guerra, MS 212-774-7361 or guerram@hss.edu
Elianna Kaplowitz, AB at 212-774-7614 or kaplowitze@hss.edu
ClinicalTrials.gov identifier: NCT00198068

Belimumab (BENLYSTA®) Pregnancy Registry (BPR) – Prospective Cohort Study of Pregnancy Outcomes Following Benlysta Exposure Within 4 Months Prior to and/or During Pregnancy

First filed February 2012, updated April 2020 - Recruiting

CATEGORIES: Pregnancy

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies in women with systemic lupus erythematosus (SLE) who have First filed belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

To Learn More Contact
US GSK Clinical Trials Call Center at 877-379-3718 or  GSKClinicalSupportHD@gsk.com
ClinicalTrials.gov identifier: NCT01532310

A Phase 2 Safety and Efficacy Study of Filgotinib and GS-9876 in Participants with Lupus Membranous Nephropathy (LMN)

First filed Sept. 2017, updated May 2020 - Completed

CATEGORIES: Lupus Nephritis

CATEGORIES: Lupus Nephritis

The purpose of thisPhase 3 study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

To Learn More Contact
GS-US-437-4093@gilead.com 
ClinicalTrials.gov identifier: NCT03285711

Study to Evaluate BIIB059 in CLE With or Without SLE (LILAC)

First filed June 2016, verified Sept. 2020 - Completed

CATEGORIES: Skin

This multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study intends 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).

Study sponsor: Biogen

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

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

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

Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

first filed Dec. 2017, updated Aug. 2020 - Active, Not Recruiting

CATEGORIES: General SLE

This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose.

To Learn More Contact
Tara Temple at 513-444-4694  or Tara.Temple@INCResearch.com
ClinicalTrials.gov identifier: NCT03371251

Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus

first filed March 2018, updated Sept. 2020 - Recruiting

CATEGORIES: General SLE

The phase 1b part of the study is a double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety, tolerability, PK, and PD of AMG 592 in subjects with SLE. Subjects will be treated for a total of 12 weeks after which they will be followed for an additional 6 weeks for safety and additional PK/PD data collection. Three dosing cohorts are planned for the phase 1b part of the study.

The phase 2a part of the study is a 52-week multicenter, double-blind, placebo-controlled study in subjects with moderate to severe SLE or cutaneous lupus with inadequate response to standard of care therapy. The phase 2a part of the study will commence after a RP2D is identified. Subjects will be randomly assigned in a 2:1 ratio to either AMG 592 or placebo.

To Learn More Contact
Amgen Call Center at 866-572-6436 or medinfo@amgen.com
ClinicalTrials.gov identifier: NCT03451422

Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus

First filed December 2007, updated June 2020 - Recruiting

CATEGORIES: General SLE

CATEGORIES: General SLE

Co-sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), this observational study aims to characterize immune system abnormalities, genetic components, and disease progression in people with systemic lupus erythematosus and mixed connective tissue disease.

To Learn More Contact
Judith Pignac-Kobinger, MS at 305-243-8567 or jpignac@med.miami.edu
Eric L. Greidinger, MD at 305-243-8913 or egreidinger@med.miami.edu
ClinicalTrials.gov identifier: NCT00582881

Genotype-Phenotype Study of Patients With Plaquenil-Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene

First filed July 2010, updated Sept. 2020 - Recruiting

CATEGORIES: General SLE

CATEGORIES: General SLE
First posted June, 2010; Last updated August, 2022

Sponsored by the National Eye Institute, this observational study is looking at whether differences in a person’s genes explain why some people develop toxicity to the retina as a result of treatment with plaquenil while others do not.

To Learn More Contact
Patient Recruitment and Public Liaison Office at 1-800-411-1222 or prpl@mail.cc.nih.gov.
ClinicalTrials.gov identifier: NCT01145196

Study of Systemic Lupus Erythematosus

First filed Nov. 1999, updated Oct. 2020 - Recruiting

CATEGORIES: General SLE

The U.S. National Institutes of Health (NIH) is conducting a research study for patients with lupus. Doctors want to learn more about the disease and are looking for what causes it, how it progresses over time, and the genetic factors that might make a person more likely to develop it. The study is being conducted at the NIH Clinical Center in Bethesda, Maryland.

To Learn More Contact
Elizabeth Joyal, R.N. at (301) 435-4489 or ejoyal@mail.cc.nih.gov.
ClinicalTrials.gov identifier: NCT00001372

Study of Families with Twins or Siblings Discordant for Rheumatic Disorders

First filed Feb. 2003, updated Oct. 2020 - Recruiting

CATEGORIES: General SLE

Sponsored by the National Institute of Environmental Health Sciences (NIEHS), this observational study will examine families in which one sibling has developed a systemic rheumatic disease such as lupus and one has not, to see if and how the two differ in the following: Blood cell metabolism; Types of cells in the blood; Environmental or genetic factors that might explain why one developed disease and the other did not.

To Learn More Contact
Frederick W Miller, M.D. at (301) 451-6273 or millerf@mail.nih.gov.
ClinicalTrials.gov identifier: NCT00055055

Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry (SABLE)

First filed Nov. 2012, updated Aug. 2020 - Active, Not Recruiting

CATEGORIES: General SLE

This study will collect blood and other optionally donated tissue samples from people with all different types of health conditions including lupus, as well as healthy control samples, in order to provide biomedical researchers with quality biospecimens that are necessary in translating basic science research into clinically relevant information and technology. Participants can donate from home, track their sample, and help advance medical research.

To Learn More Contact
US GSK Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com
ClinicalTrials.gov identifier: NCT01729455

A Multi-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives

First filed Aug. 2013, updated Oct. 2019

CATEGORIES: General SLE

This study will collect blood and other optionally donated tissue samples from people with all different types of health conditions including lupus, as well as healthy control samples, in order to provide biomedical researchers with quality biospecimens that are necessary in translating basic science research into clinically relevant information and technology. Participants can donate from home, track their sample, and help advance medical research.

To Learn More Contact
Desiree Roma at 877-864-3053 or study@sanguinebio.com
ClinicalTrials.gov identifier: NCT01931644