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Assessing the effects of Upadacitinib on Systemic Lupus Erythematosus

SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

Phase 3 Interventional AbbVie · NCT05843643

This study is testing if Upadacitinib can safely help adults with moderate to severe Systemic Lupus Erythematosus feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 63 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsmethotrexate, prednisone, upadacitinib
Locations339 sites (Chandler, Arizona and 338 other locations)
Trial IDNCT05843643 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderate to severe Systemic Lupus Erythematosus who meet specific clinical criteria.

Not a fit: Patients with mild SLE or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Systemic Lupus Erythematosus, leading to better patient outcomes.

How similar studies have performed: Previous studies have shown promise with similar treatments for autoimmune diseases, but this specific application of Upadacitinib for SLE is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 338 other locations

+289 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSLEUpadacitinibLupus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.