> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/program-to-assess-adverse-events-and-change-in-disease-b73a5178-2de0-4b93-8284-bd1bd93120dd > Record changed: 2026-10-13 # Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus NCT05843643 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Participants 1,014 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Start date 2023-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) Number of sites 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Acronym** SELECT-SLE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Short title** Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Official title** SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Dates **Completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **First posted** 2023-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Registry last updated** 2026-04-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Primary completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Start date** 2023-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Size and sites **Actual participants** 1,014 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Participants** 1,014 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Number of sites** 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Identifiers **Registry ID** NCT05843643 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **ClinicalTrials.gov ID** NCT05843643 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Outcomes ### Primary outcomes 1. Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response Timeframe: At Week 52 BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity. ### Secondary outcomes 1. Percentage of Flares Participants Experiencing Over Time. Timeframe: Week 52 Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year. 2. Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4 Timeframe: At Week 52 SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), \\< 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group \\\[BILAG\\\] A or \\> 1 new BILAG B). 3. Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) Timeframe: At Week 52 LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score \\<= 4 excluding hSLEDAI activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA \\<= 1), and concomitant medication usage. 4. Time to First Flare per SELENA SLEDAI Flare Index (SFI) Timeframe: Week 52 SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. 5. Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent Timeframe: From Week 44 to Week 52 Achievement of oral glucocorticoid dose \\<=7.5 mg/day prednisone-equivalent among participants taking \\>= 10 mg/day prednisone-equivalent at baseline. 6. Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints Timeframe: Week 52 Achievement of \\>= 50% improvement in tender or swollen joints among participants with \\>= 3 swollen joints and \\>= 6 total affected joints at Baseline. 7. Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score Timeframe: Week 52 CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of \\>= 50% reduction in CLASI activity score among participants with baseline score \\>=10. 8. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4 Timeframe: Baseline to Week 52 The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. 9. Change from Baseline in Lupus Pain Numerical Rating Scale (NRS) Timeframe: At Week 52 The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain. 10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS) Timeframe: Baseline to Week 52 The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 63 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Sites - AZ Arthritis and Rheumatology /ID# 261848Chandler, United States - AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767Flagstaff, United States - Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820Gilbert, United States - Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824Glendale, United States - Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845Mesa, United States - Arizona Arthritis & Rheumatology Research /ID# 273555Peoria, United States - Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831Phoenix, United States - Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825Phoenix, United States - HonorHealth Rheumatology /ID# 261953Scottsdale, United States - Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828Tucson, United States - Arthritis and Rheumatism Associates /ID# 253033Jonesboro, United States - Kaiser Permanente Lakeview Medical Offices /ID# 253906Anaheim, United States - David S. Hallegua MD, A Professional Corporation /ID# 253902Beverly Hills, United States - Wallace and Lee Center /ID# 275129Beverly Hills, United States - Wallace Rheumatic Studies Center, LLC /ID# 252806Beverly Hills, United States - Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870Chula Vista, United States - Providence - St. Jude Medical Center /ID# 252822Fullerton, United States - Hemet, United States - Newport Huntington Medical Group /ID# 252827Huntington Beach, United States - Moores Cancer Center at UC San Diego /ID# 253903La Jolla, United States - Arthritis & Osteo Medical Ctr /ID# 252812La Palma, United States - Wagdy Kades, M.D., Inc /ID# 272065Los Angeles, United States - Providence St. Johns Health Center /ID# 253905Santa Monica, United States - Millennium Clinical Trials /ID# 252817Thousand Oaks, United States - Cohen Medical Centers /ID# 268524Thousand Oaks, United States And 344 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## References ### Other registry identifiers (2) - 2023 - 2023-503655-10-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05843643) ## Related records ### Drugs (1) - [Upadacitinib tartrate](https://trialight.com/data/asset/upadacitinib-tartrate-d4be96e3-53b4-4c52-b14a-5df155bd386e.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (1) - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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