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

First filed Sept. 2005, updated May 2018

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 September 2018

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

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

First filed May 2016, updated December 2018

CATEGORIES: Lupus Nephritis

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Study sponsor: Boehringer Ingelheim

To Learn More Contact
Boehringer Ingelheim Call Center at1-800-243-0127 or  clintriage.rdg@boehringer-ingelheim.com
ClinicalTrials.gov identifier: NCT02770170

Dynamic Imaging of Variation in Lupus Nephritis (DIVINE)

First filed April 2017, updated December 2018

CATEGORIES: Lupus Nephritis

This multicenter trial is using a variety of kidney imaging tools, including magnetic resonance imaging to evaluate and monitor the kidneys of patients with lupus nephritis (LN) to determine if these non-invasive tools could replace surgical biopsy.

To Learn More Contact
Rebecca Bender at 434-477-2675 or rebeccabender@ampel.org
ClinicalTrials.gov identifier: NCT03180021

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

First filed Sept. 2017, verified December 2018

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

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2)

First filed July 2018, verified August 2018

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
Antonia Coeshall at 441962715493 or acoeshall@auriniapharma.com
Laura Lisk at (0)7790555604 or llisk@auriniapharma.com
ClinicalTrials.gov identifier: NCT03597464

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

First filed June 2016, verified November 2018

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

A Phase 2 Safety and Efficacy Study of Filgotinib and GS-9876 in Cutaneous Lupus Erythematosus

First filed April 2017, updated December 2018

CATEGORIES: Skin

The purpose of this randomized, double blind, placebo-controlled study is to evaluate the safety and efficacy of filgotinib and GS-9876 in participants with active Cutaneous Lupus Erythematosus. The trial is sponsored by Gilead Sciences, Inc.

To Learn More Contact
GS-US-436-4092@gilead.com
ClinicalTrials.gov identifier: NCT03134222

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

First filed January 2015, updated December 2018

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

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

first filed January 2016, updated June 2018

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

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 March 2018

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

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 November 2018

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

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

first filed May 2017, updated December 201

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.

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

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

first filed Dec. 2017, updated February 2018

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 October 2018

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

JBT-101 in Systemic Lupus Erythematosus

first filed March 2017, updated November 2018

CATEGORIES: General SLE

One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate JBT-101, a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body’s normal processes, to resolve innate immune responses without immunosuppression. The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit. Studies are also planned to evaluate tolerability and inflammation.

To Learn More Contact
Andrew Shaw at 516-562-2591
Latchmin Persaud at 516-562-3814.
ClinicalTrials.gov identifier: NCT03093402

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

first filed May 2018, updated November 2018

CATEGORIES: General SLE

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

To Learn More Contact
Study Contact at 844-434-4210 or JNT.CT@sylogent.com
ClinicalTrials.gov identifier: NCT03517722.

A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis

first filed January 2018, verified August 2018

CATEGORIES: General SLE

This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks. The study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).

To Learn More Contact
Nektar Recruitment at 855-482-8676 or StudyInquiry@nektar.com
ClinicalTrials.gov identifier: NCT03556007

A Study of NKTR-358 in Participants With Systemic Lupus Erythematosis (SLE)

first filed June 2018, verified November 2018

CATEGORIES: General SLE

The main purpose of this study is to evaluate the safety and tolerability of a study drug known as NKTR-358 in participants with SLE. NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance.

To Learn More Contact
Nektar Recruitment at 855-482-8676 or StudyInquiry@nektar.com
ClinicalTrials.gov identifier: NCT03556007

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus

first filed Aug. 2017, updated December 2018

CATEGORIES: General SLE

This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).  First in class to be tested in lupus, BMS-9865165 is a potent, highly-selective inhibitor of Tyrosine kinase 2 (Tyk2) that suppresses pathways implicated in lupus. Recruiting sites have contact information.

To Learn More Contact
Please contact the sites directly. If there is no contact information, please email Clinical.Trials@BMS.com
ClinicalTrials.gov identifier: NCT03252587

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

first filed November 2018, updated December 20

CATEGORIES: General SLE

This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

To Learn More Contact
clinical-trials-disclosure@idorsia.co
ClinicalTrials.gov identifier: NCT03742037

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

First filed December 2007, updated October 2018

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 August 2018

CATEGORIES: General SLE

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 December 2018

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 December 2018

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

Blood Component Collection From Patients With Rheumatic Disease and Healthy Volunteers

First filed Feb. 2002, updated August 2018

CATEGORIES: General SLE

This observational study will collect blood components from normal volunteers and patients with rheumatic diseases such as lupus. Patients must be participating in a current protocol of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The study is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

To Learn More Contact
Sarfaraz A Hasni, M.D. at (301) 451-1599 or hasnisa@mail.nih.gov
ClinicalTrials.gov identifier: NCT00031174

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

First filed Nov. 2012, updated July 2018

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 April 2018

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