Assessing the effects of Upadacitinib on Systemic Lupus Erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of Upadacitinib in adults with moderate to severe Systemic Lupus Erythematosus (SLE). Participants will be randomly assigned to receive either Upadacitinib or a placebo in a double-blind manner, ensuring that neither the participants nor the researchers know who receives which treatment. The study will monitor adverse events and changes in disease activity over the course of the trial. It consists of four sub-studies to comprehensively assess the drug's impact on SLE.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
* At Screening, must have at least one of the following:

  * antinuclear antibody (ANA) positive (titer \>= 1:80)
  * anti-double stranded deoxyribonucleic acid (dsDNA) positive
  * anti-Smith positive
* Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
* Physician's Global Assessment (PhGA) \>= 1 during screening period.
* On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with

  * antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
  * and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
  * and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).

Exclusion Criteria:

* Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
* Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
* Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
* Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
* History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Pregnancy, breastfeeding, or considering becoming pregnant during the study.
* Clinically relevant or significant ECG abnormalities at Screening.
* Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• AZ Arthritis and Rheumatology /ID# 261848
  Chandler, Arizona, United States Recruiting
• AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
  Flagstaff, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
  Gilbert, Arizona, United States Recruiting
• Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845
  Mesa, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Research /ID# 273555
  Peoria, Arizona, United States Recruiting

+289 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.