A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE

JRCT ID: jRCT2061230060

Registered date:14/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 24/10/2023
• Target sample size: 1000
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

(Study1: 52 weeks)
- upadacittinib doseA (oral)
- placebo (oral)
(Study2: 52 weeks)
- upadacittinib doseA
- placebo
(Study3: 52 weeks)
- Low Disease Activity (LDA) Upadacitinib Dose A
--Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
- LDA Upadacitinib Dose B
--Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
- No LDA Upadacitinib Dose A
--Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
- Upadacitininb Dose A
--Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
- Open Label Upadacitinib Dose A
--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.
- Open Label Upadacitinib Dose B
--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.

Outcome(s)

• Primary Outcome: Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response at week52

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 63age old
• Gender: Both

Include 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 adjudicated 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 >= 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)

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05843643