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New drug 608 aims to ease back pain in ankylosing spondylitis

NCT ID NCT07261644

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests an experimental drug called 608 in 500 adults with active ankylosing spondylitis (AS), a type of arthritis that causes back pain and stiffness. Participants receive either 608 injections or a placebo. The main goal is to see if 608 improves symptoms like pain and mobility better than placebo.

What this could mean

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

Active substance
608 (an experimental drug given as a subcutaneous injection)
What this could lead to
If successful, this could provide a new treatment option to reduce pain and stiffness in people with active ankylosing spondylitis.
What could go wrong
This is an early Phase 3 trial, so results may not confirm benefit. The drug could have side effects or fail to outperform placebo.

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

About 500 people

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

Started

Nov 2025

Expected to finish

Nov 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. Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily; 2. At least 18 years of age at the time of signing the ICF, with no gender restrictions; 3. Meet the 1984 modified New York criteria for ankylosing spondylitis (AS); 4. Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment; 5. Willing to practice contraception and have no plans for pregnancy, sperm donation, or egg donation from the screening period until at least 6 months after the last dose. Exclusion Criteria: 1. Patients with other uncontrolled active inflammatory diseases. 2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance 3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 4. History of cancer. 5. Known or suspected history of immunosuppression.

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis

As listed by the trial registrant

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

Ankylosing spondylitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site 01

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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