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​

AstraZeneca Tulip SC

IRB# 21-3344

Christopher Striebich, MD, PhD

The purpose of this multinational, randomized, placebo-controlled, and double-blind study is to evaluate the efficacy and safety of SC anifrolumab in adult patients with moderate-to-severe SLE despite receiving standard therapy

1. Males or females age 18 to 70 years of age inclusive at the time of signing the ICF

2. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF

3. Autoantibody-positive at Screening, as determined by the central laboratory, for at least one of the following:

(a) Antinuclear antibody (ANA) immunofluorescent assay test (titer ≥ 1:80)

(b) Anti-dsDNA

(c) Anti-Smith (anti-Sm)

  • If a patient’s clinical disease activity is predominantly due to arthritis, the patient must have at least 3 tender and 3 swollen joints
  • If a patient’s clinical disease activity is predominantly due to mucocutaneous activity, rash must be present with or without alopecia, mucosal ulcers
BILAG2004 level A disease in ≥ 1 organ system or BILAG2004 level B disease in ≥ 2 organ systems

Chong Pedrick 

303-724-7518

Chong.Pedrick@cuanschutz.edu

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

ALLEGORY

21-3268

Christopher Striebich, MD, PhD

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of OBINUTUZUMAB versus placebo among participants with active, autoantibody-positive SLE treated with standard therapy

1. Adult women or men (ages 18-75) with confirmed, active SLE

2. An SLEDAI score of 8 or greater

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

303-724-7518

Chong.Pedrick@cuanschutz.edu

 

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

 

TOPAZ

IRB# 22-0670

Christopher Striebich, MD, PhD
A multicenter, randomized, placebo-controlled, phase 3 study to evaluate the efficacy and safety of BIIB059 in adult participants with active SLE receiving background non-biologic standard of care treatment. 

Participants must be at least 18 years old and diagnosed with SLE at least 24 weeks prior, meeting 2019 EULAR/ACR classification criteria for SLE.

Disease activity will be determined by modified SLEDAI-2K and BILAG scores at screening.

-Must have a modified clinical SLEDAI 2K score of at least 4 (excluding anti-dsDNA, low complement, alopecia, fever, headache and organic brain syndrome)

 

And

-Must have a BILAG2004 level A disease in ≥ 1 organ system or BILAG2004 level B disease in ≥ 2 organ systems

Chong Pedrick

303-724-7518

Chong.Pedrick@cuanschutz.edu

 

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

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

303-724-7518

Chong.Pedrick@cuanschutz.edu

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

 

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.

Rheumatology (SOM)

CU Anschutz

Barbara Davis Center for Diabetes

1775 North Aurora Court

3102

Aurora, CO 80045


303-724-7605

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