Study on Izokibep for Patients with Non-infectious Uveitis

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What is this study about?

This clinical trial is focused on studying a condition called non-infectious uveitis, which affects the middle, back, or entire eye. Uveitis is an inflammation of the eye that can cause redness, pain, and vision problems. The study is testing a new treatment called Izokibep, which is given as an injection under the skin. Izokibep is being compared to a placebo to see how well it works in treating this eye condition.

The purpose of the study is to evaluate the effectiveness and safety of Izokibep in people with non-infectious uveitis. Participants in the study will receive either Izokibep or a placebo and will be monitored over a period of time to see how their condition responds to the treatment. The study will last for up to 52 weeks, with regular check-ups to assess the health of the participants’ eyes and overall well-being.

Throughout the study, participants will be closely observed to track any changes in their condition and to ensure their safety. The main goal is to determine if Izokibep can help reduce the symptoms of uveitis and improve the quality of life for those affected by this condition. This research could lead to new treatment options for people living with non-infectious uveitis.

1 joining the study

Upon joining the study, the patient is required to provide signed informed consent. This includes agreeing to comply with the study’s requirements and restrictions.

The patient must be between 18 and 75 years old and have a diagnosis of non-infectious intermediate-, posterior-, or pan-uveitis.

2 initial assessment

The patient undergoes an initial assessment to confirm active disease. This involves checking for inflammatory lesions in the eye using various imaging techniques.

The patient must have been on a stable dose of oral corticosteroids for at least two weeks prior to the first day of the study.

3 screening for tuberculosis

A tuberculosis (TB) test is conducted to ensure the patient does not have active TB. This can be a QuantiFERON test or a purified protein derivative (PPD) test.

If the patient has a positive PPD test but a history of Bacillus Calmette Guerin vaccination, a negative QuantiFERON test is required.

4 medication administration

The patient receives izokibep or a placebo through subcutaneous injection. The solution is prepared with a specific formulation buffer.

The main objective is to evaluate the efficacy of izokibep compared to the placebo, focusing on the time to treatment failure from week 10 to week 52.

5 monitoring and follow-up

The patient is monitored for treatment failure, quiescence, and changes in vision and retinal thickness.

Regular assessments of laboratory values, vital signs, and any adverse events are conducted throughout the study.

6 completion of the study

The study is expected to conclude by June 19, 2025. The patient will have completed all required assessments and follow-ups by this date.

Who Can Join the Study?

The person must have signed a form agreeing to participate and follow the study’s rules.
The person must be between 18 and 75 years old.
The person must have a diagnosis of non-infectious intermediate-, posterior-, or pan-uveitis. Uveitis is an inflammation inside the eye.
The person must have active eye disease, even after taking stable doses of corticosteroids (a type of medication) for at least 2 weeks before starting the study.
The person must currently be taking oral corticosteroids at a stable dose for at least 2 weeks before starting the study.
The person must not have a known history of active tuberculosis (TB), which is a serious lung infection.
The person must have a negative TB test at the start of the study. This can be shown by a negative QuantiFERON test or a negative PPD test, which are tests for TB.
Men and women must use birth control methods as required by local regulations during the study and for at least 8 weeks after the last dose of the study drug.
Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
The person must have shown an inadequate response to adalimumab (a medication) or cannot take adalimumab for medical reasons.

Who Cannot Join the Study?

Patients with an active infection cannot participate. This means if you currently have an infection, you are not eligible.
Patients who have had a recent surgery or are planning to have surgery soon are not eligible. Surgery refers to any medical procedure that involves cutting into the body.
Patients who are pregnant or breastfeeding cannot take part in the study. This is to ensure the safety of both the mother and the baby.
Patients with a history of severe allergic reactions to medications are not eligible. An allergic reaction is when your body reacts badly to something, like a rash or difficulty breathing.
Patients who are currently participating in another clinical trial are not eligible. This is to avoid any interference between different studies.
Patients with certain eye conditions that are not related to the study’s focus are not eligible. This means if you have an eye problem that is not being studied, you cannot participate.
Patients who have used certain medications recently that might affect the study results are not eligible. This includes medications that could interfere with the study drug.
Patients with a history of drug or alcohol abuse are not eligible. Abuse means using these substances in a way that is harmful to your health.
Patients with certain medical conditions that could affect the study results are not eligible. This includes conditions that might make it unsafe for you to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Oftex s.r.o.	Pardubice	Czechia
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Fondation A De Rothschild	Paris	France
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hopital Beaujon	Clichy	France
Fakultni Thomayerova nemocnice	Prague	Czechia
Uniklinikum Salzburg	Salzburg	Austria
Uuzbxblrxf Mpqxcbt Cghtyo Hdmovtcnqbxjlfvfg	Hamburg	Germany
Uubaxuahgryarrlcxfzvh Mgxzrltm Aiv	Munster	Germany
Cbn Cqmnt Rzdddrydpvu	Lyon	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	29.06.2022
Czechia	Not recruiting	29.06.2022
France	Not recruiting	29.06.2022
Germany	Not recruiting	29.06.2022
Italy	Not recruiting	29.06.2022
Spain	Not recruiting	29.06.2022

Trial locations

Investigated drugs:

Izokibep

Izokibep is a medication being studied for its effectiveness and safety in treating non-infectious uveitis, which is an inflammation of the middle layer of the eye. The trial aims to determine if this medication can help reduce the symptoms of uveitis and prevent treatment failure over a period of time.

Non-infectious Intermediate-, Posterior-, or Pan-uveitis – This is an inflammatory condition affecting the uvea, the middle layer of the eye, which can lead to vision problems. Intermediate uveitis primarily affects the vitreous, the gel-like substance in the eye, while posterior uveitis affects the retina and choroid at the back of the eye. Pan-uveitis involves inflammation of all parts of the uvea. The disease can cause symptoms such as blurred vision, floaters, and eye pain. Over time, it may lead to complications like cataracts or glaucoma if not managed properly. The inflammation can be chronic, with periods of flare-ups and remissions.

Trial ID:

2024-514975-16-00

Protocol code:

21103

NCT ID:

NCT05384249

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Izokibep for Patients with Non-infectious Uveitis

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