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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HS-10374 Dose 1

Group Type EXPERIMENTAL

HS-10374

Intervention Type DRUG

Administered orally QD for 16 weeks

HS-10374 Dose 2

Group Type EXPERIMENTAL

HS-10374

Intervention Type DRUG

Administered orally QD for 16 weeks

Placebo

Group Type PLACEBO_COMPARATOR

HS-10374-matched placebo tablets

Intervention Type DRUG

Administered orally QD for 16 weeks

tofacitinib

Group Type ACTIVE_COMPARATOR

Tofacitinib 5Mg Tab,Oral

Intervention Type DRUG

Administered orally BID for 16 weeks

Interventions

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HS-10374

Administered orally QD for 16 weeks

Intervention Type DRUG

HS-10374-matched placebo tablets

Administered orally QD for 16 weeks

Intervention Type DRUG

Tofacitinib 5Mg Tab,Oral

Administered orally BID for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No