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

Karen Franklin

303-724-0581

Karen.Franklin@CUAnchutz.edu

 

Chong Pedrick

303-724-0581

Chong.Pedrick@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

Karen Franklin​

303-724-0581

Karen.Franklin@CUAnschutz.edu

SMILE (Study of Anti-Malarials in Incomplete Lupus Erythematosus)
20-0141
Susan Boackle, MD
​Use of an approved medication (hydroxychloroquine) to prevent development of additional clinical and immunologic features of SLE. This study includes a placebo group.

Analysis on-going, but closed to recruitment

 

 

 


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.