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Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
NCT05843643 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Study Locations (20)
Arizona
- AZ Arthritis and Rheumatology /ID# 261848 — Chandler
- AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767 — Flagstaff
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820 — Gilbert
- Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824 — Glendale
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845 — Mesa
- Arizona Arthritis & Rheumatology Research /ID# 273555 — Peoria
- Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831 — Phoenix
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825 — Phoenix
- HonorHealth Rheumatology /ID# 261953 — Scottsdale
- Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828 — Tucson
California
- Kaiser Permanente Lakeview Medical Offices /ID# 253906 — Anaheim
- David S. Hallegua MD, A Professional Corporation /ID# 253902 — Beverly Hills
- Wallace and Lee Center /ID# 275129 — Beverly Hills
- Wallace Rheumatic Studies Center, LLC /ID# 252806 — Beverly Hills
- Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870 — Chula Vista
- Providence - St. Jude Medical Center /ID# 252822 — Fullerton
- Private Practice - Dr. Chandrakant V. Mehta /ID# 275100 — Hemet
- Newport Huntington Medical Group /ID# 252827 — Huntington Beach
- Moores Cancer Center at UC San Diego /ID# 253903 — La Jolla
Arkansas
- Arthritis and Rheumatism Associates /ID# 253033 — Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-07-19 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05843643
The ClinicalTrials.gov registry entry for NCT05843643 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05843643 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Arizona, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05843643 about?
NCT05843643 is a clinical study titled "Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus". 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 activ...
What is the current status of trial NCT05843643?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2023-07-19. Estimated completion is 2027-10.
What conditions does trial NCT05843643 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05843643?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05843643?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05843643 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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