Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06176508

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

Led by Hansoh BioMedical R&D Company · Updated on 2024-07-18

160

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects between the ages of 18-75 years.
  • History of psoriatic arthritis for at least 6 months and meets Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
  • Active arthritis with at least 3 swollen joints (66 joint count) and 3 tender joints (68 joint count) at screening and baseline.
  • Active plaque psoriatic skin lesion or documented history of plaque psoriasis at screening.
  • High-sensitivity C-reactive protein (hs-CRP) level of 3 mg/L or higher at screening.
  • Either no prior exposure to biologics or failed/intolerant to one TNF-inhibitor.
Not Eligible

You will not qualify if you...

  • Non-plaque psoriasis types such as guttate, inverse, pustular, erythrodermic or drug-induced psoriasis, except nail psoriasis which is allowed.
  • Other autoimmune or autoinflammatory conditions like rheumatoid arthritis, systemic lupus erythematosus, or gout, except inactive inflammatory bowel disease or autoimmune uveitis for at least 12 months.
  • Active fibromyalgia syndrome.
  • Recent or chronic active infection, or risk of serious infection.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

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Research Team

H

Hejian Zou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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