Efficacy and Safety of Ivarmacitinib Monotherapy in the Treatment of csDMARDs-IR Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Ivarmacitinib — DRUG
  4-week screening period 12-week core treatment period: Emmacitinib 4mg group, oral administration, once daily. 12-week extended treatment period: Emmacitinib 4mg group or 8mg group, oral administration, once daily. 4-week follow-up period period

Study Details

Rheumatoid arthritis (RA) is a chronic autoimmune disease affecting small joints, with a global prevalence of 0.5%-1.0% and 0.42% in China (around 5 million patients, mostly female and over 55). By 2050, RA patients worldwide are estimated to reach 31.7 million, an 80.2% increase from 2020. RA causes high disability rates, economic burdens, and can affect internal organs, leading to complications. Current treatments include csDMARDs (e.g., methotrexate, first-line but ineffective in half to two-thirds of patients), bDMARDs, tsDMARDs, NSAIDs, glucocorticoids, and traditional Chinese medicine. Studies have explored bDMARDs' efficacy in csDMARDs-IR patients. Switching to or adding upadacitinib improves ACR20 response rates, with monotherapy showing higher safety. Filgotinib also showed superior efficacy over placebo in methotrexate-IR patients. Ivarmacitinib, a novel JAK1 inhibitor, blocks cytokine signaling to reduce inflammation. A Phase II study (SHR0302-201) in moderate-to-severe RA patients showed ivarmacitinib 8 mg group had the highest ACR20 response rate (77.8%) after 12 weeks, with a dose-response relationship observed for ACR50/70 and DAS28-CRP improvements. TEAEs occurred in 73.9% of ivarmacitinib-treated patients, mostly infections, with upper respiratory tract infection being the most common. A Phase III study (SHR0302-301) also in moderate-to-severe RA patients showed similar results after 24 weeks, with the ivarmacitinib 8 mg group again having the highest ACR20 response rate (75.1%). AEs were comparable between placebo and ivarmacitinib 4 mg groups but higher in the 8 mg group, with upper respiratory tract infection, anemia, and hyperlipidemia being common. This project aims to investigate ivarmacitinib's therapeutic efficacy and safety in csDMARDs-IR RA patients, providing evidence for its use as a second-line treatment and exploring its effects at the single-cell sequencing and RNA-seq levels, offering new treatment options.

Key Dates

First listed

Mar 5, 2026

Start date

Mar 1, 2026

Status verified

Mar 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ivarmacitinib Monotherapy
  4-week screening period 12-week core treatment period: Emmacitinib 4mg group, oral administration, once daily. 12-week extended treatment period: Emmacitinib 4mg group or 8mg group, oral administration, once daily. 4-week follow-up period period

Primary Outcome Measure

Proportion of patients achieving a 20% improvement in the American College of Rheumatology criteria (ACR 20) at Week 12. [ Time Frame: Week 12 ]

Central Contacts

• Lingli Prof. Dong, Ph.D.
  +86-83663435
  [email protected]

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