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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2024-11-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR0302 tablets compared with placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A

SHR0302 tablets dose 1+ Placebo dose 2

Group Type EXPERIMENTAL

SHR0302 tablets、Placebo

Intervention Type DRUG

SHR0302 tablets dose 1 for 48 weeks

Treatment group B

SHR0302 tablets dose 2+ Placebo dose 1

Group Type EXPERIMENTAL

SHR0302 tablets、Placebo

Intervention Type DRUG

SHR0302 tablets dose 2 for 48 weeks

Treatment group C

Placebo dose1 + placebo dose 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks

Interventions

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SHR0302 tablets、Placebo

SHR0302 tablets dose 1 for 48 weeks

Intervention Type DRUG

SHR0302 tablets、Placebo

SHR0302 tablets dose 2 for 48 weeks

Intervention Type DRUG

Placebo

SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No