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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
Date last updated
5/11/2024

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
Scientific title
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Secondary ID [1] 0 0
2023-503655-10-00
Secondary ID [2] 0 0
M23-699
Universal Trial Number (UTN)
Trial acronym
SELECT-SLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
Timepoint [1] 0 0
At Week 52
Secondary outcome [1] 0 0
Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
Timepoint [2] 0 0
At Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
Timepoint [3] 0 0
At Week 52
Secondary outcome [4] 0 0
Time to First Flare per SELENA SLEDAI Flare Index (SFI)
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
Timepoint [5] 0 0
From Week 44 to Week 52
Secondary outcome [6] 0 0
Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
Timepoint [10] 0 0
Baseline to Week 52

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).
Minimum age
18 Years
Maximum age
63 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,SA,VIC,WA
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 256249 - Botany
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital /ID# 257945 - Concord
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice /ID# 253542 - Darlinghurst
Recruitment hospital [4] 0 0
Royal Darwin Hospital /ID# 263160 - Tiwi
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital /ID# 253826 - Woodville
Recruitment hospital [6] 0 0
Emeritus Research /ID# 256800 - Camberwell
Recruitment hospital [7] 0 0
Monash Medical Centre /ID# 255678 - Clayton
Recruitment hospital [8] 0 0
Colin Bayliss Research and Teaching Unit /ID# 261077 - Victoria Park
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
0811 - Tiwi
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
6100 - Victoria Park
Recruitment outside Australia
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Baranya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05843643
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05843643