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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 (SELECT-SLE)

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ClinicalTrials.gov Identifier: NCT05843643
Recruitment Status : Recruiting
First Posted : May 6, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 25, 2023
First Posted Date  ICMJE May 6, 2023
Last Update Posted Date April 12, 2024
Actual Study Start Date  ICMJE July 19, 2023
Estimated Primary Completion Date October 2, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2023)
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2024)
  • Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year) [ Time Frame: 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.
  • Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4 [ Time Frame: 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).
  • Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) [ Time Frame: 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.
  • Time to First Flare per SELENA SLEDAI Flare Index (SFI) [ Time Frame: 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.
  • Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent [ Time Frame: 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.
  • Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints [ Time Frame: Week 52 ]
    Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.
  • Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score [ Time Frame: 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.
  • Change from Baseline in Lupus Pain Numerical Rating Scale (NRS) [ Time Frame: Baseline to 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.
  • Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4 [ Time Frame: 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.
  • Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2023)
  • Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year) [ Time Frame: 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.
  • Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4 [ Time Frame: 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).
  • Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) [ Time Frame: 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.
  • Time to First Flare per SELENA SLEDAI Flare Index (SFI) [ Time Frame: 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.
  • Percentage of Participants Achieving Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent [ Time Frame: From Week 44 to Week 52 ]
    Achievement of glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.
  • Change from Baseline in Lupus Pain Numerical Rating Scale (NRS) [ Time Frame: Baseline to Week 28 ]
    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.
  • Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints [ Time Frame: Week 52 ]
    Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.
  • Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4 [ Time Frame: Baseline to Week 28 ]
    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.
  • Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS) [ Time Frame: Baseline to Week 28 ]
    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.
  • Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Official Title  ICMJE SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Upadacitinib
    Oral Tablets
    Other Name: RINVOQ
  • Drug: Placebo
    Oral Tablet
Study Arms  ICMJE
  • Experimental: Study 1- Upadacitinib Dose A
    Participants will receive upadacitinib dose A once daily for 52 weeks.
    Intervention: Drug: Upadacitinib
  • Placebo Comparator: Study 1- Placebo
    Participants will receive upadacitinib matching placebo once daily for 52 weeks.
    Intervention: Drug: Placebo
  • Experimental: Study 2- Upadacitinib Dose A
    Participants will receive upadacitinib dose A once daily for 52 weeks.
    Intervention: Drug: Upadacitinib
  • Placebo Comparator: Study 2- Placebo
    Participants will receive upadacitinib matching placebo once daily for 52 weeks.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Upadacitinib
  • 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.
    Intervention: Drug: Upadacitinib
  • 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.
    Intervention: Drug: Upadacitinib
  • 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.
    Intervention: Drug: Upadacitinib
  • 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.
    Intervention: Drug: Upadacitinib
  • 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.
    Intervention: Drug: Upadacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2023)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2027
Estimated Primary Completion Date October 2, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 63 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   China,   Colombia,   Croatia,   Estonia,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina,   Belgium,   Chile,   Mexico,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT05843643
Other Study ID Numbers  ICMJE M23-699
2023-503655-10-00 ( Other Identifier: EU CT )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP