Psoriatic ArthritisPhase 3NCT04957550
To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis
A Phase 3 study of Psoriatic Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2021to 13 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Psoriatic Arthritis Subjects
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
- Being tested
- SHR0302 tablets、Placebo, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302 tablets、PlaceboDrug
SHR0302 tablets dose 1 for 48 weeks
SHR0302 tablets、PlaceboDrug
SHR0302 tablets dose 2 for 48 weeks
PlaceboDrug
SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR0302 tablets dose 1+ Placebo dose 2 Receives: Drug: SHR0302 tablets、Placebo |
| Treatment group B | Experimental | SHR0302 tablets dose 2+ Placebo dose 1 Receives: Drug: SHR0302 tablets、Placebo |
| Treatment group C | Placebo comparator | Placebo dose1 + placebo dose 2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24
Secondary outcomes (3)
ACR20 response rate at week 48
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48
Measured: Week 48
ACR50/70 response rate at week 24 and week 48
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 50%/70% (ACR50/70) at week 24 and week 48
Measured: Week 24 and week48
Change from baseline in DAS28-CRP week 24 and week 48
Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48
Measured: Week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start30 Aug 2021
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR0302 tablets compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957550
- Sponsor's protocol ID
- SHR0302-303
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided