Current Studies Seeking Volunteers

The following list of current clinical trials is largely of national studies conducted at more than two locations; some are conducted at the National Institutes of Health (NIH) Clinical Health Center in Bethesda, Maryland. The list is divided into observational and interventional studies and further categorized as general lupus, cutaneous (discoid lupus), pregnancy, lupus nephritis or pediatric.

Observational Study
The NIH defines an observational study as one in which “investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.”

Clinical Trial (Interventional Study)
NIH defines a clinical trial (also called an interventional study) as one in which “participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet.”


Observational Studies

General Systemic Lupus Erythematosus

A Multi-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives (First filed Aug. 2013, updated April 2018)
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 Roman at study@sanguinebio.com or call 877-864-3053. Please refer to this study by its ClinicalTrials.gov identifier: NCT01931644.

Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry (SABLE) (First filed Nov. 2012, updated July 2018)
The purpose of the SABLE registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. Information on the effectiveness of BENLYSTA will also be collected. To learn more, contact US GSK Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT01729455.

Blood Component Collection From Patients With Rheumatic Disease and Healthy Volunteers (First filed Feb. 2002, updated August 2018)
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, hasnisa@mail.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT00031174.

Study of Families with Twins or Siblings Discordant for Rheumatic Disorders (First filed Feb. 2003, updated October 2018)
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, millerf@mail.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT00055055.

Study of Systemic Lupus Erythematosus (First filed Nov. 1999, updated November 2018)
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, please contact: Elizabeth Joyal, R.N. at (301) 435-4489, ejoyal@mail.cc.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT00001372.

Genotype-Phenotype Study of Patients With Plaquenil-Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene (First filed July 2010, updated August 2018)
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, prpl@mail.cc.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT01145196.

Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus (First filed December 2007, updated October 2018)
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, jpignac@med.miami.edu or Eric L. Greidinger, MD at 305-243-8913, egreidinger@med.miami.edu. Please refer to this study by its ClinicalTrials.gov identifier: NCT00582881.


Pregnancy

Belimumab (BENLYSTA®) Pregnancy Registry (BPR) - Prospective Cohort Study of Pregnancy Outcomes Following Benlysta Exposure Within 4 Months Prior to and/or During Pregnancy NCT01532310(First filed Jan. 2012, updated Aug. 2016)
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 E-mail GSKClinicalSupportHD@gsk.com

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS) (PROMISSE) (First filed Sept. 2005, updated May 2018)
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, guerram@hss.edu or Elianna Kaplowitz, AB at 212-774-7614, kaplowitze@hss.edu. Please refer to this study by its ClinicalTrials.gov identifier: NCT00198068


Cutaneous/Discoid

Use the search tool to see if there are studies in your area.


Lupus Nephritis

Use the search tool to see if there are studies in your area.


Pediatric Lupus

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Clinical Trial (Interventional Studies)

General Systemic Lupus Erythematosus

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosusn (first filed Aug. 2017, updated December 2018)
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. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@BMS.com.  Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252587.

A Study of NKTR-358 in Participants With Systemic Lupus Erythematosis (SLE) (first filed June 2018, verified November 2018)
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 email StudyInquiry@nektar.com.  Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556007.

A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis (first filed January 2018, verified August 2018)
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 Director of Clinical Operations at 650 822-5617 or dbomba@kezarbio.com.  Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393013.

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus (first filed May 2018, updated November 2018)
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, call Study Contact at 844-434-4210 or JNT.CT@sylogent.com.  Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517722.

JBT-101 in Systemic Lupus Erythematosus (SLE) (first filed March 2017, updated November 2018)
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 or Latchmin Persaud at 516-562-3814. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093402.

Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus (first filed March 2018, updated October 2018)
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, medinfo@amgen.com.  Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451422.

Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care (first filed Dec. 2017, updated February 2018)
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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371251.

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus (first filed May 2017, updated December 2018)
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. Please refer to this study by its ClinicalTrials.gov identifier: NCT03161483. 

A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) (first filed November 2016, updated November 2018)
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.  Please refer to this study by its ClinicalTrials.gov identifier: NCT02975336.

Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) (LILAC) (First filed June 2016, updated November 2018)
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, visit this website www.lupusresearchstudies.com  or contact: Biogen at clinicaltrials@biogen.com.  Please refer to this study by its ClinicalTrials.gov identifier: NCT02847598. 

A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Active Systemic Lupus Erythematosus (SLE) (First filed Nov., 2016, updated March, 2018)
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. Please refer to this study by its ClinicalTrials.gov identifier: NCT02953821.

A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) (first filed January 2016, updated June, 2018)
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, James Posada, Ph.D. at 208 727 7010 or email at jp@resolvebio.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02660944.

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus (first filed January 2016, updated November, 2018)
This current Phase 2 study will evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE. The trial is sponsored by Janssen Research & Development, LLC. To learn more, visit the dedicated trial website. Please refer to this study by its ClinicalTrials.gov identifier: NCT02349061.

Role of PPAR-y Anonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE) (First filed Jan. 2015, updated November, 2018)
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 call 800-411-1222 ext. TTY8664111010 or email prpl@mail.cc.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT02338999.

 


Pregnancy

See Observational Studies

Use the search tool to see if there are studies in your area.


Cutaneous/Discoid

A Phase 2 Safety and Efficacy Study of Filgotinib and GS-9876 in Cutaneous Lupus Erythematosus  (First filed April 2017, updated December, 2018)
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 email GS-US-436-4092@gilead.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT03134222.

Study to Evaluate BIIB059 in CLE With or Without SLE (LILAC) (First filed June 2016, verified November, 2018)
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). To learn more, email clinicaltrials@Biogen.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02847598. Study sponsor: Biogen.

Use the search tool to see if there are studies in your area.


Lupus Nephritis

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2) (First filed July, 2018, verified August 2018)
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). For more information, contact eitherAntonia Coeshall at 441962715493 or acoeshall@auriniapharma.com or Laura Lisk44 at (0)7790555604 or llisk@auriniapharma.comPlease refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597464. 

A Phase 2 Safety and Efficacy Study of Filgotinib and GS-9876 in Participants with Lupus Membranous Nephropathy (LMN) (First filed Sept. 2017, verified November 2018)
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 LMN who continue to have protein in their urine despite being treated with available therapies. The trial is sponsored by Gilead Sciences, Inc. To learn more email GS-US-437-4093@gilead.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT03285711.

Dynamic Imaging of Variation in Lupus Nephritis (DIVINE) (First filed April 2017, updated December 2018)
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 about this study, you or your doctor may contact Rebecca Bender at 434-477-2675 or rebeccabender@ampel.org.  Please refer to this study by its ClinicalTrials.gov identifier: NCT03180021.

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (First filed May 2016, updated November 2018)
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. To learn more, contact Boehringer Ingelheim Call Center at1-800-243-0127 or email: clintriage.rdg@boehringer-ingelheim.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02770170. Study sponsor: Boehringer Ingelheim.

 

Pediatric Lupus

Use the search tool to see if there are studies in your area.

Lupus Associated Complications

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST (First filed Jan. 2016, updated September 2018)
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.  To learn more about this study, contact catalyst@reatapharma.com or visit www.CATALYSTtrial.com.  Please refer to this study by its ClinicalTrials.gov identifier: NCT02657356. 
 


Note: This is not a complete list. Use this search tool to find studies in your area.

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