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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06176508
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hansoh BioMedical R&D Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hejian Zou, PhD
Principal Investigator Affiliation Huashan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: HS-10374 Dose 1

Experimental: HS-10374 Dose 2

Placebo Comparator: Placebo

Active Comparator: tofacitinib

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Hejian Zou, PhD

hjzou@unirheuma.org

+86-13311881366

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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