Clinical trial NCT06176508: Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2023-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16
timeFrame: At week 16
Secondary outcomes:
measure: Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12
timeFrame: At week 12
measure: Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16
timeFrame: At week 16
measure: Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16
timeFrame: At week 16
measure: Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16
timeFrame: At week 16
measure: Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16
timeFrame: At week 16
measure: Proportion of participants meeting Static physician's global assessment (sPGA) 0/1 score at week 16
timeFrame: At week 16
measure: Change from baseline in Psoriasis body surface area (BSA) at week 16
timeFrame: At week 16
measure: Change from baseline in the dermatology life quality index (DLQI) scores at week 16
timeFrame: At week 16
measure: Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score at week 16
timeFrame: At week 16
measure: Change from baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) at week 16
timeFrame: At week 16
measure: Proportion of participants meeting Minimal Disease Activity (MDA) response at week 16
timeFrame: At week 16
measure: Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at week 16
timeFrame: At week 16
measure: Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) at week 16
timeFrame: At week 16
measure: Change from baseline in the Short Form-36 Survey (SF-36) score at week 16
timeFrame: At week 16
measure: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis as one of their presentations of PsA at week 16
timeFrame: At week 16
measure: Change from baseline in dactylitis by Leed's dactylitis index (LDI) at week 16
timeFrame: At week 16
measure: Change from baseline in enthesitis by Leed's enthesitis index (LEI) at week 16
timeFrame: At week 16
measure: Incidence of adverse events (AEs), serious adverse events (SAEs)
timeFrame: Baseline to Week 20
measure: Ctrough of HS-10374
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Hejian Zou, PhD
role: PRINCIPAL_INVESTIGATOR
References: