NCT06176508 Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
| NCT ID | NCT06176508 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2026-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2024-02-26 with a primary completion date of 2026-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hejian Zou, PhD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06176508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06176508 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06176508 currently recruiting?
Yes, NCT06176508 is actively recruiting participants. Contact the research team at hjzou@unirheuma.org for enrollment information.
Where is the NCT06176508 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06176508 clinical trial?
NCT06176508 is sponsored by Hansoh BioMedical R&D Company. The principal investigator is Hejian Zou, PhD at Huashan Hospital. The trial plans to enroll 160 participants.