BridgeMD
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).
EU CTIS ID: 2023-503655-10-00
What this study is testing
Study 1 and Study 2 (Replicate Phase 3 Studies): The objective is to evaluate the safety and efficacy of upadacitinib compared with placebo for the treatment of signs and symptoms of SLE for 52 weeks in adults with moderately to severely active SLE. The primary efficacy objective is to demonstrate superiority of upadacitinib compared to placebo with respect to the primary endpoint in adult subjects with moderately to severely active SLE despite background therapy. Study 3 (Long-term extension): The primary objective is to evaluate the long-term safety of upadacitinib in adults with moderately to severely active SLE. Study 4 (Continued Long-term extension) The primary objective is to evaluate the long-term safety of upadacitinib in adults with moderately to severely active SLE.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult individuals, 18 years (or acceptable age according to local regulations, whichever is older) to 63 years of age, inclusive, at Screening.
- Clinical diagnosis of SLE at least 24 weeks prior to Screening as defined by the 2019 EULAR/ACR classification criteria for SLE.
- At Screening, must have at least one of the following: ANA+ (titer ≥1:80); anti-dsDNA+; anti-Smith+
- hSLEDAI ≥6, of which ≥4 points are clinical (not based on laboratory criteria), independently reviewed by 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.
- 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: o antimalarial(s) [hydroxychloroquine ≤400 mg daily, chloroquine ≤500 mg daily, quinacrine ≤100 mg daily]; o and/or prednisone (or prednisone-equivalent) (≤20 mg daily); o 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)
You likely can't join if
- Laboratory values meeting the following criteria within the screening period prior to Baseline: Serum AST > 2.0 × upper limit of normal ULN; Serum ALT > 2.0 × ULN; Serum albumin < 2.0 g/dL (< 20 g/L); WBC < 1,200/μL; ALC < 300/μL;ANC < 1,000/μL; Platelet count < 50,000/μL; Hemoglobin < 9 g/dL; Estimated GFR by simplified 4-variable MDRD formula < 30 mL/min/1.73 m2 ; Urine protein/creatinine ratio ≥2.5 mg protein/mg creatinine (282.5 mg protein/mmol creatinine).
- 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)
- Active neuropsychiatric SLE (excluding lupus headache), as defined by the CNS portion of hSLEDAI or BILAG meeting criteria to score A or B, at Screening, or signs or symptoms of neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
- A known persistent high-risk antiphospholipid antibody profile (defined as lupus anticoagulant, double positivity, or triple positivity) who are not on anticoagulation or on low-dose aspirin, unless a reason to not take low dose aspirin is documented by the investigator (for anti-cardiolipin and anti--β2 glycoprotein-1, the threshold for positivity is > 40 GPL or MPL. Double positivity means 2 of the following, and triple positivity means three, of the following, are positive: lupus anticoagulant, anticardiolipin IgG or IgM, anti-β2 glycoprotein-1 IgG or IgM); For subjects with a known high risk antiphospholipid antibody profile for whom participation in this clinical trial is considered the most suitable treatment option among treatment alternatives and the risks and benefits have been discussed with the subject, the investigator must document a favorable benefit-risk assessment to justify the subject's inclusion in the study.
- 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.
See the full eligibility criteria
Who can join
- Adult individuals, 18 years (or acceptable age according to local regulations, whichever is older) to 63 years of age, inclusive, at Screening.
- Clinical diagnosis of SLE at least 24 weeks prior to Screening as defined by the 2019 EULAR/ACR classification criteria for SLE.
- At Screening, must have at least one of the following: ANA+ (titer ≥1:80); anti-dsDNA+; anti-Smith+
- hSLEDAI ≥6, of which ≥4 points are clinical (not based on laboratory criteria), independently reviewed by 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.
- 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: o antimalarial(s) [hydroxychloroquine ≤400 mg daily, chloroquine ≤500 mg daily, quinacrine ≤100 mg daily]; o and/or prednisone (or prednisone-equivalent) (≤20 mg daily); o 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)
What rules you out
- Laboratory values meeting the following criteria within the screening period prior to Baseline: Serum AST > 2.0 × upper limit of normal ULN; Serum ALT > 2.0 × ULN; Serum albumin < 2.0 g/dL (< 20 g/L); WBC < 1,200/μL; ALC < 300/μL;ANC < 1,000/μL; Platelet count < 50,000/μL; Hemoglobin < 9 g/dL; Estimated GFR by simplified 4-variable MDRD formula < 30 mL/min/1.73 m2 ; Urine protein/creatinine ratio ≥2.5 mg protein/mg creatinine (282.5 mg protein/mmol creatinine).
- 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)
- Active neuropsychiatric SLE (excluding lupus headache), as defined by the CNS portion of hSLEDAI or BILAG meeting criteria to score A or B, at Screening, or signs or symptoms of neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
- A known persistent high-risk antiphospholipid antibody profile (defined as lupus anticoagulant, double positivity, or triple positivity) who are not on anticoagulation or on low-dose aspirin, unless a reason to not take low dose aspirin is documented by the investigator (for anti-cardiolipin and anti--β2 glycoprotein-1, the threshold for positivity is > 40 GPL or MPL. Double positivity means 2 of the following, and triple positivity means three, of the following, are positive: lupus anticoagulant, anticardiolipin IgG or IgM, anti-β2 glycoprotein-1 IgG or IgM); For subjects with a known high risk antiphospholipid antibody profile for whom participation in this clinical trial is considered the most suitable treatment option among treatment alternatives and the risks and benefits have been discussed with the subject, the investigator must document a favorable benefit-risk assessment to justify the subject's inclusion in the study.
- 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.
- 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®).
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Japan
- Puerto Rico
- United Kingdom
- South Africa
- Turkey
- Korea, Republic of
- Mexico
- Australia
- Serbia
- Canada
- New Zealand
- United States
- Chile
- Switzerland
- Bosnia and Herzegovina
- Israel
- Argentina
- Guatemala
- China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Japan; Puerto Rico; United Kingdom; South Africa; Turkey and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.