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Can a biologic combo match steroids for uveitis?

NCT ID NCT06310837

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether adalimumab biosimilars combined with immunosuppressive drugs work as well as corticosteroids combined with immunosuppressants for adults with noninfectious intermediate, posterior, or panuveitis. The trial enrolls about 128 people aged 18 to 70 who have active uveitis despite taking prednisone. Participants are randomly assigned to receive either adalimumab biosimilar injections plus mycophenolate mofetil or oral corticosteroids plus mycophenolate mofetil, and researchers track changes in vision over 24 weeks.

What this could mean

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

Active substance
adalimumab biosimilars combined with immunosuppressive agents
What this could lead to
If the combination works as well as steroids, it could offer a way to control uveitis while avoiding long-term corticosteroid side effects like weight gain and high blood sugar.
What could go wrong
The trial is relatively small and only tests whether the biologic is not worse than steroids, not whether it is better. Biologics can cause infections and allergic reactions, and some participants may still need steroids.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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. Age 18 to 70 years old ( including boundary value ), male or female. 2. At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis. 3. Subject is on prednisone ≥ 10 mg/day (or corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from screening to baseline visit. 4. At least one eye is diagnosed as active uveitis at baseline; 5. Subject is voluntary to participate in the study and sign the informed consent form. Exclusion Criteria: 1. Subject with isolated anterior uveitis. 2. Subject with prior inadequate response to or intolerance to high-dose corticosteroids (equivalent of prednisone 1 mg/kg/day or 60 to 80 mg/day). 3. Subject is suspected or diagnosed as infectious uveitis. 4. Uncontrolled glaucoma or high intraocular pressure, defined as intraocular pressure\>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence of glaucomatous optic nerve injury. 5. Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR \> 1.34 or \<20 letters) in the better eye. 6. Subject with other fundus diseases. 7. Subject with demyelinating diseases. 8. Subject has a contraindication to pupil dilation with mydriatic eyedrops. 9. Subject with corneal or lens opacity that precludes visualization of the anterior segment and fundus. 10. Topical corticosteroids and/or topical NSAID\>3 drops per day in the 14 days prior to baseline; Dexamethasone/betamethasone or equivalent subconjunctival steroid within 30 days prior to baseline; Parafbulbar, intravitreal (IVT), suprasoroidal, or periocular corticosteroid injections were administered within 60 days prior to baseline; Received IVT anti-VEGF therapies less than 60 days prior to baseline; Dexamethasone (Ozurdex) IVT implant within 6 months prior to baseline; Fluocinolone acetonide IVT implant within 3 years prior to baseline. 11. Subject with history of prior intraocular surgery within 90 days prior to baseline or any planned (elective) eye surgery within the next 1 year from baseline. 12. Subject is diagnosised or suspected tuberculosis, hepatitis B virus, hepatitis C virus, HIV, syphilis infection or with other uncontrolled active infections or other infections that would put the subject at uncontrolled risk. 13. Subject with severe, progressive, or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral diseases or with malignant tumors or with moderate to severe heart failure and subjects who are considered by the investigator to be at unacceptable risk by participating in the study. 14. Prior biologic and immunosuppressant therapy other than corticosteroids at any time. 15. Subject with a systemic inflammatory disease that requires continued therapy with oral corticosteroids or a prohibited immunosuppressive agent at Screening or Baseline visits. 16. Fertile woman who has a positive serum pregnancy test at the screening visit or plans for pregnancy and sperm donation during the trial and within 6 months after the end of the study. 17. Other subjects who are considered by the investigator to be inappropriated for enrollment.

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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

  • Shenzhen Eye Hospital

    Shenzhen, Guangdong, 518040, China

More trials for these conditions

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