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

Hansoh Pharma

Status and phase: Enrolling; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: HS-10374-matched placebo tablets; Drug: Tofacitinib 5Mg Tab,Oral; Drug: HS-10374

Study type: Interventional

Funder types: Industry

Identifiers

NCT06176508

HS-10374-202

Details and patient eligibility

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 4 patient groups, including a placebo group

HS-10374 Dose 1

Experimental group

Treatment:

Drug: HS-10374

HS-10374 Dose 2

Experimental group

Treatment:

Drug: HS-10374

Placebo

Placebo Comparator group

Treatment:

Drug: HS-10374-matched placebo tablets

tofacitinib

Active Comparator group

Treatment:

Drug: Tofacitinib 5Mg Tab,Oral