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LuCIN Clinical Studies

The Lupus Clinical Investigators Network (LuCIN) is a North American-based lupus clinical trials network composed of fifty-seven (57) of the most reputable academic research medical centers in the world. LuCIN brings together the biopharmaceutical industry and lupus experts to evaluate the safety and effectiveness of new therapies for lupus. The investigators and other specialized personnel within LuCIN are experts at planning and conducting lupus clinical research on new investigational drugs or repurposed drugs, since these repurposed drugs have already been extensively tested for other diseases and found to be safe and less risky.

To learn more about the current portfolio of ongoing clinical trials being conducted within LuCIN as of September 1, 2020, please continue reading below.

Primary Objective: The study aims to evaluate the efficacy of dapirolizumab pegol (DZP) in study participants who have persistent active or frequently relapsing-remitting SLE with moderate to severe disease activity despite being on stable non-biological standard of care (SOC) medication and thereby have an unmet medical need for a treatment intervention with new therapies.

  • Product: Dapirolizumab pegol
  • Study Sponsor: UCB
  • 34 LuCIN sites (U.S. and Canada)
  • Study Status: Study start-up/Actively recruiting
  • Learn more

Primary Objective: 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.

  • Product: AMG 570
  • Study Sponsor: Amgen, Inc.
  • 24 LuCIN sites (U.S. and Canada)
  • Study Status: Actively recruiting

A study to demonstrate the effectiveness of a novel modality (Dynamic Contrast Enhanced MRI) to assess lupus nephritis

 

Primary Objective: To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI) blood oxygen level-dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), to evaluate the intra-renal blood flow, perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus nephritis (LN). Then compare these parameters to renal biopsy findings to determine whether DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal function and pathology in LN.

  • Study Sponsor: RILITE Foundation
  • 7 LuCIN sites (U.S. only)
  • Study Status: Enrollment Complete

A phase II, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the safety and efficacy of M2951 in subjects with Systemic Lupus Erythematosus (SLE)

 

Primary Objective: To evaluate the efficacy and dose response of evobrutinib (also referred to as M2951) compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive SLE who are receiving standard-of-care therapy.

  • Partnership with Merck/EMD Serono, Inc and IQVIA, LLC.
  • Product: M2951
  • Study Sponsor: EMD Serono
  • 8 LuCIN sites (U.S. and Canada)
  • Study Status: Complete

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CC-220 in subjects with active Systemic Lupus Erythematosus (SLE)

 

Primary Objective: To evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active SLE using the SLE Responder Index at week 24.

  • Partnership with Celgene, Inc and PPD International, LLC.
  • Product – CC-220
  • Study Sponsor: Celgene
  • 23 LuCIN sites (U.S. and Canada)
  • Study Status: Enrollment Complete

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus

Primary Objective: Evaluate the efficacy and safety of LY3471851 in adult patients with SLE. Results of this study will be used to guide the dose selection for future studies and to further characterize the benefit/risk profile of LY3471851.

  • Product: LY3471851
  • Study Sponsor: Lilly
  • 20 LuCIN sites (U.S. and Canada)
  • Study Status: Study Start-up/Not actively recruiting

A phase III study of ustekinumab in participants with active Systemic Lupus Erythematosus

Primary Objective: This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double-blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

  • Partnership with Janssen and PAREXEL, LLC
  • Product: Ustekinumab (Stelara)
  • Study Sponsor: Janssen
  • 20 LuCIN sites (U.S. and Canada)
  • Study Status: Enrollment Complete

A double-blind, placebo-controlled randomized, multicenter study to assess changes in omega-3 index in Erythrocytes and clinical benefit after 24 weeks of daily consumption of AKBM-3031 (omega-3 phospholipids from krill), followed by a 24-week open-label extension, in patients with Systemic Lupus Erythematosus (SLE)

Primary Objective: To assess the ability of AKBM-3031 to replenish the omega-3 dietary deficiency suspected in patients with generalized lupus.

  • Partnership with Aker BioMarine, LLC
  • Product: Krill Oil
  • Study Sponsor: Aker BioMarine
  • 20 LuCIN sites (U.S. and Canada)
  • Study Status: Actively Recruiting

An investigational study to evaluate the safety and effectiveness of BMS-986165 with background treatment in participants with lupus nephritis

Primary Objective: To evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

  • Collaboration with Bristol-Myers Squibb
  • Study Sponsor: Bristol-Myers Squibb
  • Product: BMS-986165
  • 18 LuCIN Sites (US and Canada)
  • Study Status: Actively recruiting

A phase 2 randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of BMS-986165 in subjects with Systemic Lupus Erythematosus

Primary Objective: This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

  • Partnership with Bristol-Myers Squibb and PRA Health Sciences, LLC
  • Product: BMS-986165
  • Study Sponsor: Bristol-Myers Squibb
  • 22 LuCIN sites (U.S. and Canada)
  • Study Status: Actively Recruiting

A randomized, double-blind, active comparator-controlled, cross-over study to assess the capacity of delayed-release Prednisone (RAYOS®) compared to immediate-release prednisone to improve fatigue and control morning symptoms in subjects with Generalized Systemic Lupus Erythematosus

Primary Objective: To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) as assessed by the Investigator.

  • Collaboration with Horizon Pharma, Inc.
  • Study Sponsor: AMPEL BioSolutions
  • Product: RAYOS (delayed release prednisone)
  • 21 LuCIN sites (U.S. only)
  • Study Status: Enrollment Complete

A study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TAK-079 in combination with standard background therapy in participants with moderate to severe Systemic Lupus Erythematosus (SLE)

Primary Objective: The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE. The Phase 1 study will enroll patients with moderate to severe lupus and aims to evaluate the safety of TAK-079 as well as its pharmacokinetics (how it is absorbed, distributed, metabolized and excreted from the body) and its pharmacodynamics (how it works and affects the body). To join the trial, patients must have moderate to severe disease activity that has not responded well enough to standard lupus treatment.  Participants will receive up to four doses of either TAK-079 or placebo, in combination with their ongoing standard lupus treatment.

  • Partnership with Takeda and PPD
  • Product: Tak-079
  • Study sponsor: Takeda
  • 9 LuCIN sites (U.S.)
  • Study Status: Actively recruiting

Validation of a mobile phone-based ePRO tool in subjects with Systemic Lupus Erythematosus (SLE)

Primary Objective: To validate that patient-centered outcomes collected using the SF-36 health survey, a health-related quality-of-life questionnaire, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, and the Patient Global Assessment using a Mobile ePRO tool.

  • Collaboration with Pfizer, Inc.
  • Study Sponsor: Lupus Research Alliance
  • 10 LuCIN sites (U.S. and Canada)
  • Study Status: Completed

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