This randomized, double-blind, parallel-group, noninferiority clinical trial will evaluate the efficacy and safety of ivarmacitinib compared with oral prednisone in participants with mild-to-moderate active systemic lupus erythematosus (SLE) without active major organ involvement. Approximately 294 participants will be randomized in a 1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at 30 mg/day with a prespecified tapering schedule, together with the corresponding matching placebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oral prednisone in achieving the primary efficacy outcome. The primary outcome is the proportion of participants achieving remission of arthritis and/or rash, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), at Week 12. Safety and secondary efficacy outcomes will be evaluated throughout the 24-week treatment period.
Aged ≥18 years.
Fulfill the 2012 SLICC classification criteria or the 2019 EULAR/ACR classification criteria for SLE.
Have a clinical SLEDAI-2K score ≥4 and a total SLEDAI-2K score ≤12.
Have active musculoskeletal and/or mucocutaneous manifestations at screening, as assessed by the SLEDAI-2K.
Active lupus nephritis at screening, defined as 24-hour urinary protein >1 g. The 24-hour urinary protein test may be repeated once within 2 weeks; participants may be enrolled if the repeat result meets the eligibility criterion.
Active neuropsychiatric SLE (NPSLE) at screening, defined as new-onset seizure, psychosis, organic brain syndrome, visual disturbance, cranial neuropathy, lupus headache, or new-onset cerebrovascular accident.
Active hematologic involvement at screening, defined as any of the following: white blood cell count <3 × 10^9/L, platelet count <100 × 10^9/L, or hemolytic anemia.
Active gastrointestinal involvement at screening, defined as SLE-related acute pancreatitis or intestinal pseudo-obstruction.
Parallel
Ivarmacitinib Sulfate Tablets
DrugIvarmacitinib sulfate tablets, 8 mg orally once daily, plus matching prednisone acetate placebo tablets for 24 weeks. Stable background standard-of-care therapy is permitted.
Prednisone Acetate Tablets
DrugPrednisone acetate tablets administered orally once daily, starting at 30 mg/day and tapered according to the protocol-specified schedule. Participants will also receive matching placebo tablets for ivarmacitinib once daily. Stable background standard-of-care therapy is permitted.
Proportion of Participants Achieving Arthritis and/or Rash Remission as Defined by SLEDAI-2K
The SLEDAI-2K is a weighted index comprising 24 clinical and laboratory descriptors. The higher total score indicates greater disease activity. For this outcome, arthritis contributes 4 points and rash contributes 2 points when present; the corresponding item contributes 0 points when absent. For participants with arthritis only at baseline, response is defined as the absence of arthritis at Week 12. For participants with rash only at baseline, response is defined as the absence of rash at Week 12. For participants with both arthritis and rash at baseline, response is defined as the absence of arthritis, rash, or both at Week 12.
Proportion of Participants Achieving a BICLA Response
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline).
Proportion of Participants Achieving SRI-4 Response
The SRI-4 (SLE Responder Index-4) response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (\<0.3 points worsening from the baseline level).
Change From Baseline in SLEDAI-2K Total Score
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and \>12 representing severe disease activity.
Change From Baseline in Physician Global Assessment Score
Physician Global Assessment Score is used to assess the activity of systemic lupus erythematosus on a scale ranging from 0 to 3, where 0 indicates no disease activity and 3 indicates the most severe disease activity.
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