Published by TheClinResearcher | Educational Content Only
Introduction
Systemic lupus erythematosus (SLE)—commonly known as lupus—is a complex autoimmune disease that can attack almost any organ in the body. From the skin and joints to the heart, lungs, and kidneys, lupus is unpredictable, often debilitating, and currently has no cure.
Right now, AbbVie is leading a major Phase 3 lupus clinical trial called SELECT-SLE (ClinicalTrials.gov ID: NCT05843643). This research study is testing upadacitinib—already approved for other autoimmune diseases—to see if it can reduce lupus flares, lower disease activity, and improve quality of life.
Here’s everything you need to know about this study, how the drug works, and what participation might involve.
What Is the SELECT-SLE Trial?
The SELECT-SLE trial is a randomized, double-blind, placebo-controlled Phase 3 study enrolling adults with moderately to severely active systemic lupus erythematosus.
Here’s what that means:
- Randomized: Participants are assigned by chance to receive either upadacitinib or a placebo.
- Double-blind: Neither participants nor study doctors know who is receiving which treatment until the trial ends.
- Placebo-controlled: A comparison group receives an inactive pill to measure the true effect of the study drug.
All participants continue taking their standard lupus treatments—such as hydroxychloroquine, corticosteroids, or immunosuppressants—while in the study.
How Does Upadacitinib Work?
Upadacitinib—brand name RINVOQ®—is a Janus kinase (JAK) inhibitor.
In lupus, the immune system mistakenly attacks healthy tissues by releasing cytokines, chemical messengers that trigger inflammation. These signals travel through JAK pathways.
By blocking certain JAK enzymes, upadacitinib interrupts this overactive signaling, potentially reducing inflammation and preventing tissue damage—without shutting down the immune system entirely.
This targeted approach is part of a growing trend in precision immunology for autoimmune diseases.
Who Can Join the Trial?
While specific eligibility criteria vary by study site, participants generally must:
The below list is only a portion of the inclusion and exclusion criteria
- Be 18 years or older
- Have a confirmed SLE diagnosis for at least 24 weeks
- Show active disease despite standard treatments
The study plans to enroll hundreds of participants worldwide and will measure:
- SRI-4 response rate (a standard lupus disease activity measure)
- Reduction in steroid use
- Safety and tolerability of long-term use
The trial also features a long-term extension phase, allowing eligible participants to continue receiving the study drug if beneficial.
Why Consider Participating in a Clinical Trial?
Joining a lupus research study like SELECT-SLE can have several potential benefits:
- Access to Investigational Treatments – You may receive a therapy that isn’t yet available to the public, with close medical monitoring.
- Specialized Medical Care – Participants are often followed more closely than in standard care, with frequent evaluations and lab testing.
- Advancing Lupus Research – Your participation contributes to medical knowledge that may improve future treatment options for people with SLE.
- Possible Reimbursement for Time and Travel – Many lupus clinical trials offer compensation or cover costs for your time, transportation, and study-related visits. This varies by site and location—always confirm details with the trial team.
💡 Important: Clinical trial participation is voluntary. You can withdraw at any time. While reimbursement may be available, decisions to join should be based primarily on your health goals and the potential contribution to lupus research.
Why This Trial Matters
Current lupus treatments often involve broad immune suppression, which can bring side effects and leave patients vulnerable to infections. A targeted treatment like upadacitinib could:
- Reduce flares and disease activity
- Potentially improve quality of life
- Represent a new era in SLE therapy focused on precision immune modulation
How to Learn More or Participate
If you’re interested in the AbbVie SELECT-SLE trial (NCT05843643) or other clinical trials for lupus, you can explore active studies and connect with trial sites.
Disclaimer
This article is for educational purposes only and does not offer medical advice. Always consult your healthcare provider before starting, stopping, or changing any treatment, and confirm all trial details—including potential compensation—directly with the study site. Although we strive to correct accurate and up to date information, please verify for accuracy at the time of reading.