Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (NCT05843643)
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
🩺 Plain-English Summary (8th-Grade Level)
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: AZ Arthritis and Rheumatology /ID# 261848 — Chandler, Arizona
Age range: 18 Years to 63 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (369 Sites)
Showing the first 25 of 369 sites.
- AZ Arthritis and Rheumatology /ID# 261848 — Chandler, Arizona
- AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767 — Flagstaff, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820 — Gilbert, Arizona
- Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824 — Glendale, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845 — Mesa, Arizona
- Arizona Arthritis & Rheumatology Research /ID# 273555 — Peoria, Arizona
- Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831 — Phoenix, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825 — Phoenix, Arizona
- HonorHealth Rheumatology /ID# 261953 — Scottsdale, Arizona
- Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828 — Tucson, Arizona
- Arthritis and Rheumatism Associates /ID# 253033 — Jonesboro, Arkansas
- Kaiser Permanente Lakeview Medical Offices /ID# 253906 — Anaheim, California
- David S. Hallegua MD, A Professional Corporation /ID# 253902 — Beverly Hills, California
- Wallace and Lee Center /ID# 275129 — Beverly Hills, California
- Wallace Rheumatic Studies Center, LLC /ID# 252806 — Beverly Hills, California
- Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870 — Chula Vista, California
- Providence - St. Jude Medical Center /ID# 252822 — Fullerton, California
- Private Practice - Dr. Chandrakant V. Mehta /ID# 275100 — Hemet, California
- Newport Huntington Medical Group /ID# 252827 — Huntington Beach, California
- Moores Cancer Center at UC San Diego /ID# 253903 — La Jolla, California
- Arthritis & Osteo Medical Ctr /ID# 252812 — La Palma, California
- Wagdy Kades, M.D., Inc /ID# 272065 — Los Angeles, California
- Providence St. Johns Health Center /ID# 253905 — Santa Monica, California
- Millennium Clinical Trials /ID# 252817 — Thousand Oaks, California
- Cohen Medical Centers /ID# 268524 — Thousand Oaks, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
- A Study of Obexelimab in Patients With Systemic Lupus Erythematosus — Peoria, Arizona
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.