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

NCT06176508 | Recruiting Phase 2

• 1 other identifier: HS-10374-202
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16

  The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).

  At week 16

Secondary Outcomes (19)

• Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12

  At week 12

• Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16

  At week 16

• Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16

  At week 16

• Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16

  At week 16

• Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16

  At week 16

Study Arms (4)

HS-10374 Dose 1

EXPERIMENTAL

Drug: HS-10374

HS-10374 Dose 2

EXPERIMENTAL

Drug: HS-10374

Placebo

PLACEBO COMPARATOR

Drug: HS-10374-matched placebo tablets

tofacitinib

ACTIVE COMPARATOR

Drug: Tofacitinib 5Mg Tab,Oral

Interventions

HS-10374 DRUG

Administered orally QD for 16 weeks

HS-10374 Dose 1; HS-10374 Dose 2

HS-10374-matched placebo tablets DRUG

Administered orally QD for 16 weeks

Placebo

Tofacitinib 5Mg Tab,Oral DRUG

Administered orally BID for 16 weeks

tofacitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hejian Zou, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hejian Zou, PhD

CONTACT

+86-13311881366; hjzou@unirheuma.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 19, 2023
• Study Start: February 26, 2024
• Primary Completion: April 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)