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Can a new injection calm psoriatic arthritis?

NCT ID NCT06640257

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether an investigational drug called SHR-1314 can reduce joint pain, swelling, and skin symptoms in adults with active psoriatic arthritis. Participants receive either SHR-1314 or a placebo injection over 24 weeks, with follow-up for safety. The study aims to see if more people achieve a 20% improvement in arthritis symptoms compared to placebo.

What this could mean

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

Active substance
SHR-1314 injection
What this could lead to
If successful, SHR-1314 could offer a new treatment option to reduce joint pain, swelling, and skin plaques in people with psoriatic arthritis.
What could go wrong
This is a phase III trial, but results are not yet known. The drug may not prove more effective than placebo, and like other biologics, it could carry risks such as infections or allergic reactions.

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

208 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Jan 2027

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 years and older

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. The subject voluntarily signs an informed consent form before any procedures related to the research start; 2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR); 3. There is active PsA before randomization; 4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis; 5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease. Exclusion Criteria: 1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc. 2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past. 3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents. 4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Huashan Hospital of the Shanghai FuDan University

    Shanghai, Shanghai Municipality, 200433, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.