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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05843643
Registration number
NCT05843643
Ethics application status
Date submitted
25/04/2023
Date registered
6/05/2023
Titles & IDs
Public title
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
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Scientific title
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
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Secondary ID [1]
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2023-503655-10-00
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Secondary ID [2]
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M23-699
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Universal Trial Number (UTN)
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Trial acronym
SELECT-SLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo
Experimental: Study 1- Upadacitinib Dose A - Participants will receive upadacitinib dose A once daily for 52 weeks.
Placebo comparator: Study 1- Placebo - Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Experimental: Study 2- Upadacitinib Dose A - Participants will receive upadacitinib dose A once daily for 52 weeks.
Placebo comparator: Study 2- Placebo - Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Experimental: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A - Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Experimental: Study 3- Low Disease Activity Upadacitinib Dose B - Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Experimental: Study 3- No LDA Upadacitinib Dose A - Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Experimental: Study 3- Upadacitininb Dose A - Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Experimental: Study 3- Open Label Upadacitinib Dose A - Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Experimental: Study 3- Open Label Upadacitinib Dose B - Participants who reach \>= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Treatment: Drugs: Upadacitinib
Oral Tablets
Treatment: Drugs: Placebo
Oral Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
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Assessment method [1]
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BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
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Timepoint [1]
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At Week 52
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Secondary outcome [1]
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Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
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Assessment method [2]
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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).
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Timepoint [2]
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At Week 52
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Secondary outcome [3]
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Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
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Assessment method [3]
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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.
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Timepoint [3]
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At Week 52
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Secondary outcome [4]
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Time to First Flare per SELENA SLEDAI Flare Index (SFI)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
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Assessment method [5]
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Achievement of oral glucocorticoid dose \<=7.5 mg/day prednisone-equivalent among participants taking \>= 10 mg/day prednisone-equivalent at baseline.
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Timepoint [5]
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From Week 44 to Week 52
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Secondary outcome [6]
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Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
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Assessment method [6]
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Achievement of \>= 50% improvement in tender or swollen joints among participants with \>= 3 swollen joints and \>= 6 total affected joints at Baseline.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
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Assessment method [7]
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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.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to Week 52
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Secondary outcome [9]
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Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to Week 52
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Secondary outcome [10]
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Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline to Week 52
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Eligibility
Key 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).
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Minimum age
18
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Maximum age
63
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2027
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 256249 - Botany
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Recruitment hospital [2]
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Concord Repatriation General Hospital /ID# 257945 - Concord
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Recruitment hospital [3]
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Holdsworth House Medical Practice /ID# 253542 - Darlinghurst
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Emeritus Research /ID# 256800 - Camberwell
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Recruitment hospital [5]
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Monash Medical Centre /ID# 255678 - Clayton
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Recruitment hospital [6]
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Colin Bayliss Research and Teaching Unit /ID# 261077 - Victoria Park
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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6100 - Victoria Park
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Recruitment outside Australia
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Republika Srpska
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Araucania
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Region Metropolitana De Santiago
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Grad Zagreb
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Attiki
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Nograd
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Veszprem
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Israel
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Israel
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Israel
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Yerushalayim
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Italy
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Ancona
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Italy
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Roma
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Italy
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Pisa
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Miyagi
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Japan
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Miyazaki
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Japan
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Okinawa
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Yamanashi
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Japan
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Okayama
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Korea, Republic of
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Chungcheongnamdo
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Korea, Republic of
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Gwangju Gwang Yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Latvia
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Bauska
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Latvia
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Riga
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Latvia
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Adazi
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Lithuania
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Kazlu Rudos
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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New Zealand
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Auckland
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Poland
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Wielkopolskie
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Portugal
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Porto
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Portugal
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State/province [114]
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Regiao Autonoma Da Madeira
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Portugal
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State/province [115]
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Setubal
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Portugal
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State/province [116]
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Viana Do Castelo
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Puerto Rico
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Bayamon
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Puerto Rico
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San Juan
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Romania
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Cluj
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Romania
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Olt
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Serbia
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Beograd
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Serbia
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Vojvodina
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Serbia
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Novi Sad
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Slovakia
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Bratislavsky Kraj
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Slovakia
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Košice II
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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A Coruna
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Spain
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Pontevedra
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Spain
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Sevilla
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Switzerland
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Basel-Stadt
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Switzerland
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Sankt Gallen
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Switzerland
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Bern
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Taiwan
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Taipei
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Taiwan
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Keelung
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Taiwan
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Taichung
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Meram Konya
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United Kingdom
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Bolton
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United Kingdom
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Cambridgeshire
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United Kingdom
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Northamptonshire
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 3 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 based on their disease activity and their original treatment assignment in Study 1 or 2. 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.
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Trial website
https://clinicaltrials.gov/study/NCT05843643
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05843643