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Can a new pill calm psoriatic arthritis joint pain?

NCT ID NCT04957550

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase 3 trial tests whether an experimental drug called SHR0302 can reduce joint pain and swelling in people with active psoriatic arthritis, a condition that combines joint inflammation with psoriasis. About 418 adults with at least six months of symptoms and active joint disease will receive either SHR0302 or a placebo for up to 48 weeks. Researchers will measure how many participants achieve a 20% improvement in arthritis symptoms (ACR20) at week 24, with longer-term effects tracked at week 48. The study also monitors safety, including potential risks like infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR0302, an experimental JAK1 inhibitor taken as a tablet
What this could lead to
If it works, SHR0302 could offer a new daily pill to reduce joint pain and swelling in people with psoriatic arthritis, helping them manage the disease more effectively.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. The drug may not outperform placebo, and JAK inhibitors carry risks like infections and blood clots that the study will monitor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

418 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriatic arthritis

Contacts and locations

Locations

  • Peking University Hospital

    Beijing, Beijing Municipality, 200433, China

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