Status:
RECRUITING
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Lead Sponsor:
AbbVie
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-63 years
Phase:
PHASE3
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...
Eligibility Criteria
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.
Key Trial Info
Start Date :
July 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05843643
Start Date
July 19 2023
End Date
October 1 2027
Last Update
March 12 2026
Active Locations (369)
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1
AZ Arthritis and Rheumatology /ID# 261848
Chandler, Arizona, United States, 85225-2906
2
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
Flagstaff, Arizona, United States, 86001-6299
3
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
Gilbert, Arizona, United States, 85297-7336
4
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
Glendale, Arizona, United States, 85306-9802