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

NCT04957550 | Unknown Phase 3

• 1 other identifier: SHR0302-303
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR20 response rate at week 24

  Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24

  Week 24

Secondary Outcomes (3)

• ACR20 response rate at week 48

  Week 48

• ACR50/70 response rate at week 24 and week 48

  Week 24 and week48

• Change from baseline in DAS28-CRP week 24 and week 48

  Week 24 and week 48

Study Arms (3)

Treatment group A

EXPERIMENTAL

SHR0302 tablets dose 1+ Placebo dose 2

Drug: SHR0302 tablets、Placebo

Treatment group B

EXPERIMENTAL

SHR0302 tablets dose 2+ Placebo dose 1

Drug: SHR0302 tablets、Placebo

Treatment group C

PLACEBO COMPARATOR

Placebo dose1 + placebo dose 2

Drug: Placebo

Interventions

SHR0302 tablets、Placebo DRUG

SHR0302 tablets dose 1 for 48 weeks

Treatment group A

Placebo DRUG

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

Treatment group C

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Hospital

Beijing, Beijing Municipality, 200433, China

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR0302 tablets compared with placebo

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 12, 2021
• Study Start: August 30, 2021
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

CN (1)