SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Systemic Lupus Erythematosus
-
Age: Between 18 Year(s) - 63 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Adult individuals, 18 to 63 years of age
- Clinical diagnosis of SLE at least 24 weeks prior to Screening
- The subject must be on stable background treatment for = 30 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), 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)
You may not be eligible for this study if the following are true:
-
- Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
- Currently receiving hemodialysis (or other forms of renal replacement therapy).
- Antiphospholipid syndrome (APS) and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
- Current or past history of infection as defined below:
- Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
- One or more episodes of disseminated herpes simplex.
- Human immunodeficiency virus (HIV) infection
- Active TB
- Active infection(s) requiring treatment with intravenous antiinfectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit.
- Any of the following medical diseases or disorders:
- SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, aorto-coronary bypass surgery, and venous thromboembolism.
- History of an organ transplant which requires continued immunosuppression.
- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.
- History of malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ (CIS) of the cervix.
- Any planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
- Pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
- Received IV or IM corticosteroid greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days prior to Baseline; or treated with intra-articular, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 30 days prior to Baseline.
- Received any of the following treatments prior to Baseline within the
timeframes noted below:
- < 6 months for plasmapheresis.
- < 3 months for cyclophosphamide.
- < 1 month for IVIG or GCSF.
- < 1 month for lenalidomide, thalidomide, or Acthar gel.
- < 1 week for high potency opiates.
- < 5 half-lives for any investigational drug or those drugs not specified above.
- Prior exposure to a systemic or topical JAK inhibitor (including Tyk2 inhibitors), including but not limited to commercial upadacitinib (Rinvoq®), tofacitinib (Xeljanz®), ruxolitinib (Jakafi® or Opzelura®), delgocitinib (Corectim®), baricitinib (Olumiant®), peficitinib (Smyraf®), abrocitinib (Cibinqo®), filgotinib (Jyseleca®), fedratinib (Inrebic), and deucravacitinib (Sotyktu®).
- Received any live vaccine with replicating potential within 28 days (or longer if required locally) prior to Baseline. Live vaccines that are incapable of replicating are permitted.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.