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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Page 1 of 93 (369 locations)

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

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus | DecenTrialz