Ivarmacitinib Versus Glucocorticoids in Mild-to-Moderate Systemic Lupus Erythematosus

NCT07814664 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ACACIA-SLE
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erthematosus

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (4)

• Proportion of Participants Achieving a BICLA Response

  Week 12

• Proportion of Participants Achieving SRI-4 Response

  Week 12

• Change From Baseline in SLEDAI-2K Total Score

  Week 12

• Change From Baseline in Physician Global Assessment Score

  Week 12

Study Arms (2)

Ivarmacitinib Group

EXPERIMENTAL

Drug: Ivarmacitinib Sulfate Tablets

Prednisone Group

ACTIVE COMPARATOR

Drug: Prednisone Acetate Tablets

Interventions

Ivarmacitinib Sulfate Tablets DRUG

Ivarmacitinib sulfate tablets, 8 mg orally once daily, plus matching prednisone acetate placebo tablets for 24 weeks. Stable background standard-of-care therapy is permitted.

Ivarmacitinib Group

Prednisone Acetate Tablets DRUG

Prednisone 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.

Prednisone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Be receiving a stable dose for at least 4 weeks before screening of oral glucocorticoids (prednisone ≤10 mg/day or equivalent), and/or an antimalarial agent, and/or one immunosuppressive agent.

You may not qualify if:

• 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.
• Active cardiovascular or respiratory involvement at screening, defined as active diffuse alveolar hemorrhage, interstitial pulmonary fibrosis, pulmonary arterial hypertension, myocardial involvement, or valvular heart disease.
• Active fibromyalgia at screening that, in the investigator's judgment, may interfere with assessment of SLE disease activity.
• Treatment for or presence of an active systemic inflammatory disease other than SLE within 12 weeks before screening, including rheumatoid arthritis, juvenile chronic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, or psoriatic arthritis. Participants with secondary Sjögren's syndrome are not excluded.
• Major surgery within 8 weeks before screening or anticipated need for major surgery during the study.
• Any of the following within 12 weeks before screening: venous thromboembolism (deep vein thrombosis or pulmonary embolism), myocardial infarction, unstable ischemic heart disease, or stroke; or current New York Heart Association (NYHA) class III or IV heart failure.
• History of recurrent venous thromboembolism, defined as ≥2 episodes of deep vein thrombosis and/or pulmonary embolism.
• History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disease, or any other serious and/or unstable medical condition that, in the investigator's judgment, may pose an unacceptable risk associated with administration of the investigational product or interfere with interpretation of study data.
• History of a lymphoproliferative disorder; active primary or recurrent malignancy; or malignancy in remission for \<5 years before randomization. The following exceptions are permitted:
• Cervical carcinoma in situ that has been surgically resected, with no evidence of recurrence or metastatic disease for at least 3 years.
• Basal cell or squamous cell carcinoma of the skin that has been completely excised, with no evidence of recurrence for at least 3 years.
• Clinically significant viral, bacterial, fungal, or parasitic infection within 4 weeks before randomization.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

ivarmacitinib; Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Mengtao Li

CONTACT

86-010-69159958; mengtao.li@cstar.org.cn

Leyao Ma

CONTACT

maleyaomail@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

CN (1)