Upadacitinib for Lupus
(SELECT-SLE Trial)
Recruiting in Palo Alto (17 mi)
+405 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must be taking: Antimalarials, Corticosteroids, Immunosuppressants
Disqualifiers: Lupus nephritis, Neuropsychiatric SLE, Overlap syndromes, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial does not require you to stop your current medications. You must be on a stable dose of your existing lupus treatments for at least 60 days before starting the trial, except for oral corticosteroids, which need to be stable for at least 14 days.
What makes the drug Upadacitinib unique for treating lupus?
Upadacitinib is unique for treating lupus because it is a Janus kinase (JAK) inhibitor, which works by blocking specific pathways involved in the immune response, potentially offering a new mechanism of action compared to traditional treatments like corticosteroids and immunosuppressants.
12345Eligibility Criteria
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) can join this trial. They must have been diagnosed at least 24 weeks ago, meet specific disease criteria including positive ANA and anti-dsDNA tests, and have a certain level of disease activity. Participants should be on stable SLE medication for some time before the study starts.Inclusion Criteria
I was diagnosed with lupus more than 24 weeks ago.
My lupus is active with a score of 6 or more, mainly from symptoms, not lab tests.
Physician's Global Assessment (PhGA) >= 1 during screening period.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2
52 weeks
Regular visits at a hospital or clinic
Extension
Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Upadacitinib's safety and effectiveness in treating SLE compared to a placebo. It's double-blinded, meaning no one knows who gets the real drug or placebo. The study has three parts: two main studies where participants are randomly assigned treatment or placebo for 52 weeks, followed by a third study based on their initial results.
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 3- Upadacitininb Dose AExperimental Treatment1 Intervention
Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Group II: Study 3- Open Label Upadacitinib Dose BExperimental Treatment1 Intervention
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.
Group III: Study 3- Open Label Upadacitinib Dose AExperimental Treatment1 Intervention
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.
Group IV: Study 3- No LDA Upadacitinib Dose AExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Group V: Study 3- Low Disease Activity Upadacitinib Dose BExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Group VI: Study 3- Low Disease Activity Upadacitinib (LDA) Dose AExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Group VII: Study 2- Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib dose A once daily for 52 weeks.
Group VIII: Study 1- Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib dose A once daily for 52 weeks.
Group IX: Study 1- PlaceboPlacebo Group1 Intervention
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Group X: Study 2- PlaceboPlacebo Group1 Intervention
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone Ambulatory Care Brooklyn Heights /ID# 253592Brooklyn, NY
PMG Research of Salisbury /ID# 253608Salisbury, NC
Biopharma Informatic - McAllen /ID# 253022McAllen, TX
Deerbrook Medical Associates /ID# 253029Vernon Hills, IL
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. [2019]Label="OBJECTIVES">In a post-hoc analysis, we aimed to validate the Lupus Low Disease Activity State (LLDAS) definition as an endpoint in an systemic lupus erythematosus (SLE) Phase IIb randomised controlled trial (RCT) (MUSE [NCT01438489]) and then utilize LLDAS to discriminate between anifrolumab and placebo.
Lupus community panel proposals for optimising clinical trials: 2018. [2022]Formidable impediments stand in the way of treatment development for lupus. These include the unwieldy size of current trials, international competition for scarce patients, complex outcome measures and a poor understanding of these outcomes in the world at large. The heterogeneity of the disease itself coupled to superimposition of variegated background polypharmacy has created enough immunological noise to virtually ensure the failure of lupus treatment trials, leaving an understandable suspicion that at least some of the results in testing failed drugs over the years may not have been negative, but merely uninterpretable. The authors have consulted with many clinical trial investigators, biopharmaceutical developers and stakeholders from government and voluntary sectors. This paper examines the available evidence that supports workable trial designs and proposes approaches to improve the odds of completing interpretable treatment development programs for lupus.
Algorithm for calculating high disease activity in SLE. [2021]The ability to identify lupus patients in high disease activity status (HDAS) without knowledge of the SLEDAI could have application in selection of patients for treatment escalation or enrolment in trials. We sought to generate an algorithm that could calculate via model fitting the presence of HDAS using simple demographic and laboratory values.
Clinical Pharmacokinetics and Pharmacodynamics of Biologic Therapeutics for Treatment of Systemic Lupus Erythematosus. [2018]Systemic lupus erythematosus (SLE) is a multifactorial autoimmune disease with potentially severe clinical manifestation that mainly affects women of child-bearing age. Patients who do not respond to standard-of-care therapies, such as corticosteroids and immunosuppressants, require biologic therapeutics that specifically target a single or multiple SLE pathogenesis pathways. This review summarizes the clinical pharmacokinetic and pharmacodynamic characteristics of biologic agents that are approved, used off-label, or in the active pipeline of drug development for SLE patients. Depending on the type of target, the interacting biologics may exhibit linear (non-specific) or non-linear (target-mediated) disposition profiles, with terminal half-lives varying from approximately 1 week to 1 month. Biologics given by subcutaneous administration, which offers dosing flexibility over intravenous administration, demonstrated a relatively slow absorption with a time to maximum concentration of approximately 1 day to 2 weeks and a variable bioavailability of 30-82 %. The population pharmacokinetics of monoclonal antibodies were best described by a two-compartment model with central clearance and steady-state volume of distribution ranging from 0.176 to 0.215 L/day and 3.60-5.29 L, respectively. The between-subject variability in pharmacokinetic parameters were moderate (20-79 %) and could be partially explained by body size. The development of linked pharmacokinetic-pharmacodynamic models incorporating SLE disease biomarkers are an attractive strategy for use in dosing regimen simulation and optimization. The relationship between efficacy/adverse events and biologic concentration should be evaluated to improve clinical trial outcomes, especially for biologics in the advanced phase of drug development. New strategies, such as model-based precision dosing dashboards, could be utilized to incorporate information collected from therapeutic drug monitoring into pharmacokinetic/pharmacodynamic models to enable individualized dosing in real time.
A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. [2022]To assess the efficacy/safety of the B lymphocyte stimulator inhibitor belimumab plus standard therapy compared with placebo plus standard therapy in active systemic lupus erythematosus (SLE).