Testing HS-10374 for treating active psoriatic arthritis
A Randomized, Double-blind, Placebo- and Comparator-controlled, Multicenter, Phase 2 Trial to Assess the Efficacy and Safety of HS-10374 in Adults With Active Psoriatic Arthritis
This study is testing a new medication called HS-10374 to see if it can help adults with active psoriatic arthritis feel better by reducing joint swelling and skin issues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06176508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of HS-10374 in adults with active psoriatic arthritis. Participants will receive either HS-10374 or a matched placebo, with the aim of determining the optimal dosing for future clinical development. The study will assess the impact of HS-10374 on joint swelling and tenderness, as well as skin lesions associated with psoriatic arthritis. The trial is designed for individuals who have either not been treated with biologics or have had inadequate responses to TNF-inhibitors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a history of active psoriatic arthritis and specific clinical criteria.
Not a fit: Patients with non-plaque psoriasis or other autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing active psoriatic arthritis.
How similar studies have performed: Other studies have shown promise in treating psoriatic arthritis with similar approaches, but the specific efficacy of HS-10374 is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening. 3. Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline. 4. Active plague psoriatic skin lesion or documented history of plague psoriatic at screening. 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 Criteria: 1. Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed. 2. Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator. 3. Active fibromyalgia syndrome 4. Recent history of active infection, chronic infection history or risk of serious infection.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hejian Zou, PhD — Huashan Hospital
- Study coordinator: Hejian Zou, PhD
- Email: hjzou@unirheuma.org
- Phone: +86-13311881366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.