Lupus Trials
The Division of Rheumatology strives to understand more about lupus through research. Please see the list below, which summarizes the studies available to individuals interested in advancing our understanding and treatment of rheumatic disease.
| Study Name/IRB#/PI | Brief Description | Basic Eligibility Criteria | Contact |
Lavender IRB# 24-1932 Kristen Demoruelle, MD, PhD | Evaluate the Efficacy and Safety of Anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus who are refractory adn/or intolerant to antimalarial therapy. Each study stage will have a randomized, double-blind, placebo-controlled design, followed by an open label treatment period. | 1. Adult women or men (ages 18-70) and a body weight of >=40.0 kg. 2. Confirmed diagnosis of chronic CLE (including discoid CLE adn other subtypes) and/or subacute CLE with or without systemic manifestation. 3. Either a BILAG A in one organ or a BILAG B in two organs 4. Must have current autoantibody positivity (ANA or dsDNA or anti-Smith) and low complement (C3 OR C4 OR CH50) at screening | Chong Pedrick 303-724-8948
Najeeb Arishi 303-724-8948
|
COSMIC IRB# 23-1287 Christopher Striebich, MD, PhD | Proof of concept study to evaluate the efficacy, safety, and tolerability of GS-5718 in participants with Cutaneous Lupus Erythematosus (CLE) To review the clinical trials.gov info click here | -Active cutaneous lupus (either SLE or CLE) affecting more than one area -Willingness to undergo skin punch biopsy at 2 timepoints | Chong Pedrick 303-724-8948 Najeeb Arishi 303-724-8948 |
SIRIUS IRB #23-1961 Christopher Striebich, MD, PhD | The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous injection on top of standard-of-care treatment in participants with active systemic lupus erythematosus (SLE) To review the clinical trials.gov info click here | Eligibility:
| Chong Pedrick 303-724-8948 Najeeb Arishi 303-724-8948 |
Cenerimod-IDORSIA IRB #22-1370 Christopher Striebich, MD, PhD | The goal of this clinical trial is to see how well cenerimod is in reducing symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. To review the clinical trials.gov info click here | Eligibility
| Chong Pedrick 303-724-8948 Najeeb Arishi 303-724-8948 |
BreakFree - CAR-T study in SLE, IIM and SSc 24-0289 Melissa Griffith, MD | A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, idiopathic Inflammatory Myopathy or Systemic Sclerosis |
| Chong Pedrick 303-724-8948
Najeeb Arishi 303-724-8948
Mario Farag 303-724-8948 Mario[email protected] |
GLEAM IRB #24-2239 Elena Weinstein, MD | To evaluate the efficacy of IMVT-1402 compared to placebo in participants with CLE as assessed by changes in cutaneous lupus erythematosus disease area and severity index activity (CLASI-A) score. | Eligibility
| Chong Pedrick 303-724-8948 Najeeb Arishi 303-724-8948 |
SELECT-SLE IRB# 24-1581 Christopher Striebich, MD/PhD | Study to evaluate the safety and efficacy of JAK inhibitor Upadacitinib (Rinvoq) in individuals with moderat to severe active SLE. |
| Chong Pedrick 303-724-8948 Najeeb Arishi 303-724-8948 |
Break-Free - SLE IRB# 25-0407 Melissa Griffith, MD | A Phase 2, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE) |
| Mario Farag 303-724-8948 Mario[email protected] |
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.