Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Last updated: July 17, 2024
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Joint Injuries

Psoriasis And Psoriatic Disorders

Treatment

Tofacitinib 5Mg Tab,Oral

HS-10374-matched placebo tablets

HS-10374

Clinical Study ID

NCT06176508
HS-10374-202
  • Ages 18-75
  • All Genders

Study Summary

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects between the ages of 18-75 years.

  2. Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets theClassification Criteria for Psoriatic Arthritis (CASPAR) at screening.

  3. Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68joints) at both screening and baseline.

  4. Active plague psoriatic skin lesion or documented history of plague psoriatic atscreening.

  5. hs-CRP ≥ 3mg/L at screening.

  6. Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii)have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced).

Exclusion

Exclusion Criteria:

  1. Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-inducedpsoriasis), with the exception of nail psoriasis, which is allowed.

  2. Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemiclupus erythematous, gout), with the exception of inflammatory bowel disease and/orautoimmune uveitis being inactive at least 12 months before the screening, asassessed by the investigator.

  3. Active fibromyalgia syndrome

  4. Recent history of active infection, chronic infection history or risk of seriousinfection.

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: Tofacitinib 5Mg Tab,Oral
Phase: 2
Study Start date:
February 26, 2024
Estimated Completion Date:
August 28, 2026

Connect with a study center

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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