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New antibody injection could stop gout flares while lowering uric acid

NCT ID NCT07708181

Disease control Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests an experimental drug called SSGJ-613, a lab-made antibody, to prevent sudden gout attacks in people who are starting medication to lower uric acid. About 200 adults with frequent gout flares will receive either SSGJ-613 injections or standard colchicine pills for up to 24 weeks. The goal is to see if SSGJ-613 reduces the number of flares better than the current treatment.

What this could mean

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

Active substance
an experimental anti-interleukin-1β antibody called SSGJ-613
What this could lead to
If successful, SSGJ-613 could offer a new way to prevent painful gout flares when starting urate-lowering therapy, potentially with fewer doses than daily pills.
What could go wrong
This is an early phase 2 trial with only 200 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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: * Must be 18 Years to 75 Years, both male and female. * BMI ≤40 kg/m2. * Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis. * ≥4 acute gout flares within 1 year prior to screening Exclusion Criteria: * Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc. * Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. * Presence of severe renal function impairment. * Intolerance of subcutaneous injection. * Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment. * Live vaccinations within 8 weeks prior to the start of the study. * Use of forbidden therapy.

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Conditions

The condition(s) this trial relates to.

Arthritis, Gouty gout

As listed by the trial registrant

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

Gout arthritis

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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