Lupus Trials

​The Division of Rheumatology strives to understand more about lupus through research.  Please see the list below, which summarizes the st​udies available to individuals interested in advancing our understanding and treatment of rheumatic disease. 

 

Study Name/IRB​#/PIBrief Description​Basic Eligibility​ CriteriaContact​

LOTUS

18-0907

Susan Boackle, MD

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
  • Male or female 16–75 years of age 
  • Diagnosed with SLE for at least 3 months
  • Are not responding to the current treatment regimen for SLE

There are other eligibility criteria which the study staff can discuss in more detail with interested participants

303-724-0581,
303-724-7518
or email
Karen Franklin​

IDORSIA

18-2346

Christopher Striebich, MD, PhD

A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, adaptive-design study to evaluate the efficacy, safety and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) on standard-of-care therapy
  • Men or women 18–75 years of age.
  • Diagnosis of Systemic Lupus Erythematosus made at least 6 months
  • Presence of positive autoantibodies
  • Presenting a disease activity
303-724-0581,
303-724-7518
or email
Karen Franklin​
RSLV-132
16-0603
Susan Boackle, MD
Use of new (unapproved) protein-based medication.  This study includes a placebo group.Moderately severe active skin lupus.303-724-0581,
303-724-7518
or email
Karen Franklin​

Takeda - TAK-079

19-0027

Christopher Striebich, MD, PhD

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus
  • The patient is aged 18 to 75 years.
  • The patient been diagnosed with SLE as defined by either the 2012 Systemic Lupus
    International Collaborating Clinics or the American College of Rheumatology diagnostic criteria.
  • The patient is positive for anti-dsDNA antibodies and/or anti-ENA antibodies
303-724-0581,
303-724-7518
or email
Karen Franklin​
Lupus - CC-220
18-0489
Susan Boackle, MD
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 qualify for study participation, you must:
  • be a male or female 18 years or older
  • have an SLE diagnosis of at least 6 months
  • have an SLEDAI 2K ≥ 6 points, with 4 from non-lab components
  • have an ANA with a titer of ≥ 1:80, or anti-dsDNA or anti-Sm antibodies
  • have no more than 20mg /d of Prednisone or equivalent
303-724-0581,
303-724-7518
or email
Karen Franklin​​
Lupus - DIVINE
17-2137
Susan Boackle, MD
The purpose of this study is 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) and 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.To qualify for study participation, you must:
  • Able to provide written informed consent agreeing to all study procedures, before any study- specific procedures are done.
  • be a male or female between 18 to 65 years old
  • undergoing evaluation for new or recurrent LN with a SOC kidney biopsy planned OR being evaluated for IgA nephropathy and with a SOC kidney biopsy planned
  • have a life expectancy >6 months
​​303-724-0581,
303-724-7518
or email
Karen Franklin​​

Please note that study status changes frequently and therefore, a listed study may not be actively enrolling. Also, the complete list of inclusion and exclusion criteria for a given study is often not listed due to its length.  A visit to determine an individuals eligibility may be required.  A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.