To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

Hengrui Medicine

Status and phase: Invitation-only; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: SHR0302 tablets、Placebo; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04957550

SHR0302-303

Details and patient eligibility

About

This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.

Enrollment: 444 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide signed informed consent；
2. Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；
3. Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints；
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion criteria

1. History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；
2. Non-plaque forms of psoriasis (with exception of nail psoriasis)；
3. Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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444 participants in 3 patient groups, including a placebo group

Treatment group A

Experimental group

Description:

SHR0302 tablets dose 1+ Placebo dose 2

Treatment:

Drug: SHR0302 tablets、Placebo

Drug: SHR0302 tablets、Placebo

Treatment group B

Experimental group

Description:

SHR0302 tablets dose 2+ Placebo dose 1

Treatment:

Drug: SHR0302 tablets、Placebo

Drug: SHR0302 tablets、Placebo

Treatment group C

Placebo Comparator group

Description:

Placebo dose1 + placebo dose 2

Treatment:

Drug: Placebo