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

Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus (First filed May 2017, verified May 2017)
This study will assess by measurement equivalence testing whether data collected via a smartphone are comparable to that collected in standard fashion and whether PROs obtained in the subject's environment may be more informative than that collected in the physician's office on paper. To learn more, Rebecca Bender at 434-977-2675 or rebecca.bender@ampelbiosolutions.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT03142711.

Web-based Genetic Research on Lupus (First filed Aug. 2015, verified Oct. 2016)
The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator 23andMe, Inc. partners at Pfizer. To learn more, contact Laura Russell at 650-938-6300 or lupus-help@23andme.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02530944.

A Multi-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives (First filed Aug. 2013, verified March 2016)
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, verified Jan. 2017)
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 Jan. 2017)
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 Jan. 2017)
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 Feb. 2017)
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.

Agricultural Health Study Follow-up (First filed July 2011, updated Jan. 2017)
The observational Agricultural Health Study (AHS) is looking at the long-term health effects of farming exposures including pesticides, crops, and animals among farmers and their spouses. Lupus is among the diseases noted of interest. AHS is sponsored by the National Institute of Environmental Health Sciences (NIEHS). To learn more, contact: Elizabeth L O'Connell at (919) 287-4335, oconnelle@niehs.nih.gov or Dale Sandler, Ph.D. at (919) 541-4668, sandler@niehs.nih.gov. Please refer to this study by its ClinicalTrials.gov identifier: NCT01399411.

Genotype-Phenotype Study of Patients With Plaquenil-Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene (First filed July 2010, updated Jan. 2017)
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 Feb. 2017)
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 Sept. 2016)
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

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


Clinical Trial (Interventional Studies)

General Systemic Lupus Erythematosus

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus (First filed Sept. 2016, verified Nov. 2016)
This multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study aims to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE). To learn more, contact call 888-662-6728 (U.S. and Canada) or email global.rochegenentechtrials@roche.com. Study sponsor: Genentech, Inc. Please refer to this study by its ClinicalTrials.gov identifier: NCT02908100.

Study to Evaluate BIIB059 in CLE With or Without SLE (LILAC) (First filed June 2016, verified Feb. 2017)
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.

A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (First filed June 2016, verified Feb. 2017)
The purpose of this multicenter, randomized, double blind, placebo controlled trial is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active Systemic Lupus Erythematosus receiving stable standard-of-care medications. Study sponsor UCB Pharmaceuticals. To learn more, contact: UCB Cares at+1 887 8229493. Please refer to this study by its ClinicalTrials.gov identifier: NCT02804763.

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, verified Nov. 2016)
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 Sept. 2016)
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.

CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis (first filed June 2016, updated Sept. 2016)
The purpose of this Phase 3 study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in patients who, despite corticosteroid use, continue to have active SLE according to objective measurements. The trial is sponsored by Anthera Pharmaceuticals. To learn more, contact Monica Gangalat 510-856-5600 ext 5574 or via email at mgangal@anthera.com Please refer to this study by its ClinicalTrials.gov identifier: NCT02514967.

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus (first filed January 2016, updated February 2017)
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.

A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus (first filed April 2015; updated Sept. 2016)
The purpose of this Phase II multicenter, randomized, double-blind,placebo-controlled trial is to assess the efficacy and safety of different dose regimens of the investigational drug ALX-0061 to treat patients with moderate to severe active, seropositive SLE. The trial is sponsored by Ablynx NV Belgium. To learn more, email clinicaltrials@ablynx.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02437890.

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus (First filed May 2015, updated Nov. 2016)
The purpose of this Phase 3 study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult subjects with moderate to severe active, autoantibody-positive systemic lupus erythematosus (SLE). The trial is sponsored by AstraZeneca and PRA Health Sciences. To learn more, contact AstraZeneca Clinical Study Information Center at 1-877-240-9479 or information.center@astrazeneca.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02446899.

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus (First filed May 2015, updated Nov. 2016)
The purpose of this Phase 3 study is to evaluate the efficacy and safety of the investigational drug anifrolumab given intravenously at two different doses versus placebo in adults with moderate to severe, autoantibody-positive systemic lupus erythematosus (SLE). The trial is sponsored by AstraZeneca and PRA Health Sciences. To learn more, contact AstraZeneca Clinical Study Information Center at 1-877-240-9479 or information.center@astrazeneca.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02446912.

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (First filed Oct. 2014, updated Jan. 2017)
The purpose of this placebo-controlled study sponsored by Bristol-MyersSquibb is to evaluate the safety, tolerability and effectiveness (how you feel, any side effects, or changes to your laboratory tests, benefits on the disease) of a new investigational drug (BMS-931699) that is being studied in male and female patients with Active Systemic Lupus Erythematosus (SLE). To learn more, visit: EnrollinLupusresearch.com or call 855-56-Lupus.

Role of PPAR-y Anonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE) (First filed Jan. 2015, updated Jan. 2017)
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.

Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) (ALE06) (First filed Sept. 2013, updated Feb. 2017)
This randomized Phase 2 trial sponsored by the National Institute of Allergy and Infectious Diseases is looking at whether stopping mycophenolate mofetil (MMF) reactivates disease activity in patients whose disease has been controlled with long-term MMF therapy. Click here to learn more about the study and trial locations. Please refer to this study by its ClinicalTrials.gov identifier: NCT01946880.

Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial (NILES) (First filed Feb. 2014, updated Jan. 2017)
Sponsored by the National Institute of Health, the Phase 2 multicenter NISLE study will investigate whether the drug nelfinavir will be useful for the treatment of lupus. Nelfinavir is already approved by the Food and Drug Administration for the treatment of HIV disease and has been found to be a safe medication that is well-tolerated. To learn more, contact: Andrew Shaw at 516-562-2591 or anshaw@nshs.edu. Please refer to this study by its ClinicalTrials.gov identifier: NCT02066311.

Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants with Systemic Lupus Erythematosus (First filed April 2014, updated Aug.2016)
The primary goal of this randomized, double-blind, placebo-controlled Phase 1 study is to evaluate the safety and tolerability of the investigational compound BIIB059 at varying doses as a treatment for SLE. To learn more, contact: Biogen Idec Investigatorat clinicaltrials@biogenidec.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02106897

Belimumab Assessment of Safety in SLE (BASE) (First filed Oct. 2012, updated Aug. 2016)
The BASE study, sponsored by GlaxoSmithKline, aims to further enhance the existing knowledge regarding the side effects of belimumab when given with other medicines to adults with active systemic erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. This study will also see if patients receiving belimumab with other medicines can reduce their use of steroids, such as prednisone, over 1 year. 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: NCT01705977.

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Erythematosus (SLE) (EMBRACE) (First filed June 2012, updated Feb. 2017)
The multicenter, randomized, controlled EMBRACE study aims to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus). Study participants will receive stable standard therapy for lupus in addition to receiving either placebo (no active medicine) or belimumab. 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: NCT01632241.

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus (First filed July 2014, updated Jan. 2017)
The pilot, Phase 2, randomized, placebo-controlled, double-blind, study aims to evaluate the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics and pharmacogenetics of an experimental compound CC-220 to treat adults with systemic lupus erythematosus. To learn more contact Michelle Kilcoyne at 732 652 6549, or mkilcoyne@celgene.com or call Michael Weiswasser at 732 652 6462, mweiswasser@celgene.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02185040.


Pregnancy

See Observational Studies

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


Cutaneous/Discoid

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


Lupus Nephritis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV LupusNephritis (First filed Sept. 2015, updated March, 2017)
This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN. To learn more about this study, you or your doctor may call 888-662-6728 (U.S. and Canada) or email global.rochegenentechtrials@roche.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02550652. Study sponsor: Hoffman-La Roche.

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (First filed May 2016, updated Feb. 2017)
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.

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (First filed June 2014, updated Feb. 2017)
This Phase 1b, randomized, double-blind, placebo-controlled trial aims to find a safe and well tolerated dose of investigational compound ixazomib in patients with lupus nephritis. This study will look at side effects and lab results in patients who take ixazomib, along with the determination of the pharmacokinetics. To learn more, email: medicalinformation@tpna.com. Please refer to this study by its ClinicalTrials.gov identifier: NCT02176486

Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) (First filed July 2012, updated Feb. 2017)
This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis. 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: NCT01639339.

Rituximab and Belimumab for Lupus Nephritis (First filed Oct. 2014, updated Nov. 2016)
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and the Immune Tolerance Network (ITN), the CALIBRATE study will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks. For information about the study and trial locations in the U.S. call Sanita Kandasami at the Feinstein Institute, (516) 562-2401.


Pediatric Lupus

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO) (First filed July 2012, updated Jan. 2017)
The multi-center, randomized, placebo-controlled PLUTO study aims to evaluate the safety, efficacy and pharmacokinetics of intravenous (IV) belimumab for pediatric patients 5 to 17 years of age with active systemic lupus erythematosus. 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: NCT01649765.


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

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CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis (first filed June 2016)
The purpose of this Phase 3 study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in patients who, despite corticosteroid use, continue to have active SLE according to objective measurements. The trial is sponsored by Anthera Pharmaceuticals. To learn more, contact Monica Gangalat 510-856-5600 ext 5574 or via email at mgangal@anthera.com Please refer to this study by its ClinicalTrials.gov identifier: NCT02514967.

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus (first filed January 2016, updated February 2016)
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.

global.rochegenentechtrials@roche.com

rebecca.bender@ampelbiosolutions.com