Division of Rheumatology

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
UCB IRB#25-0664	A Phase 3 Placebo controlled study evaluating the safety and effectiveness of Dapirolizumab Pegol for the treatment of active Systemic Lupus Erythematosus (SLE)	Adult women or men (age 18 and older) with confirmed, active SLE fulfilling the 2019 ACR/EULAR classification of SLE Presence of anti-dsDNA, ANA, C3, or C4 antibodies at screening. On stable medication dose (8 weeks for antimalarials, 2 weeks for corticosteroids)	Chong Pedrick 303-727-8948 [email protected]
GSK IRB# 25-1357 Christopher Striebich, MD/PhD	A phase 1 study investigating the safety, efficacy, and tolerability of GSK4527363 versus approved medication belimumab for the treatment of active SLE.	Adult women or men (age 18 to 65) with confirmed, active SLE fulfilling the 2019 ACR/EULAR classification of SLE Testing positive for ANA and/or dsDNA antibodies. Body weight >= 45 kg, with BMI of 18-32 kg/m2. On stable dose of SLE medication started at least 8 weeks prior to screening.	Chong Pedrick 303-724-8948 [email protected]
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 Ages: 18 Years to 75 Diagnosis of (SLE) made at least 6 months prior to screening	Chong Pedrick 303-724-8948 [email protected] Najeeb Arishi 303-724-8948 [email protected]
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	Adult women or men (age 18 and above) with confirmed, active SLE, IIM, SSc Fulfilling the 2019 (EULAR/ACR) classification criteria of SLE. presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening. Active disease at screening, with recent ≥ 1 major organ system with (BILAG A) score or class III or IV Lupus nephritis Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin SLE only, not drug-induced, not overlapping autoimmune diseases like (MS, Psoriasis, IBD)	Chong Pedrick 303-724-8948 [email protected] Najeeb Arishi 303-724-8948 [email protected] Mario Farag 303-724-8948 Mario[email protected]
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)	Adult women or men (age 18 and older) with confirmed, active SLE fulfilling the 2019 ACR/EULAR classification of SLE Inadequate response to GC and two or more immunosuppressant therapies Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening. Renal biopsy within 24 months	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.

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