Recruiting NCT06176508
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-10374, HS-10374-matched placebo tablets, Tofacitinib 5Mg Tab,Oral.
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug HS-10374
Administered orally QD for 16 weeks - Drug HS-10374-matched placebo tablets
Administered orally QD for 16 weeks - Drug Tofacitinib 5Mg Tab,Oral
Administered orally BID for 16 weeks
Primary outcome measures
- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16 [Time frame: At week 16]
Secondary outcome measures (12)
- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12 [Time frame: At week 12]
- Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16 [Time frame: At week 16]
- Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16 [Time frame: At week 16]
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16 [Time frame: At week 16]
- Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16 [Time frame: At week 16]
- Proportion of participants meeting Static physician's global assessment (sPGA) 0/1 score at week 16 [Time frame: At week 16]
- Change from baseline in Psoriasis body surface area (BSA) at week 16 [Time frame: At week 16]
- Change from baseline in the dermatology life quality index (DLQI) scores at week 16 [Time frame: At week 16]
- Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score at week 16 [Time frame: At week 16]
- Change from baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) at week 16 [Time frame: At week 16]
- Proportion of participants meeting Minimal Disease Activity (MDA) response at week 16 [Time frame: At week 16]
- Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at week 16 [Time frame: At week 16]
Eligibility criteria
Inclusion criteria
- Male or female subjects between the ages of 18-75 years.
- Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
- Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline.
- Active plague psoriatic skin lesion or documented history of plague psoriatic at screening.
- hs-CRP ≥ 3mg/L at screening.
- 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
- Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed.
- 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.
- Active fibromyalgia syndrome
- Recent history of active infection, chronic infection history or risk of serious infection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT06176508 · HS-10374-202