Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This clinical trial is being done in children and teenagers ages 6 months to under 18 years who have Atopic Dermatitis, also called eczema, that is moderate to severe. The study uses lebrikizumab, a medicine given as an injection under the skin, and a placebo to match LY3650150. The purpose of the study is to learn more about the long-term safety of lebrikizumab in this age group.

Participants receive study treatment over a long period of time and are followed during the study to see how they do. Some participants may receive lebrikizumab, while others may receive the placebo to match LY3650150. The study is designed to gather information over time about how safe the treatment is and how well it works for this skin condition.

1 study treatment begins

after joining the study, you begin receiving lebrikizumab, which is given as a solution for injection in a pre-filled syringe.

the study is a long-term extension study, so your treatment and follow-up continue over a long period while your safety and response are checked.

2 study treatment during the trial

you continue to receive lebrikizumab during the trial. the source data does not give a dose amount, how often it is given, or the exact length of treatment, so these details are not specified.

the study is designed for participants with moderate-to-severe atopic dermatitis, also called eczema. the main purpose is to check the long-term safety of lebrikizumab.

3 monitoring during the trial

during the study, your treatment is monitored for adverse events, which means unwanted medical problems or side effects that happen during treatment.

one main outcome of the study is whether participants stop study treatment because of adverse events.

4 end of the trial period

the trial continues until the planned study period ends. the estimated study period runs from 2023-12-01 to 2029-04-09.

at the end of the study period, the course of treatment and safety assessment for the trial is completed.

Who Can Join the Study?

Must have received treatment in study J2T-MC-KGBI before joining this study.
Must have completed the study treatment in study J2T-MC-KGBI, meaning the treatment plan from that study was finished as required.

Who Cannot Join the Study?

Any participant who has had a serious adverse event from taking part in study J2T-MC-KGBI cannot join. A serious adverse event means a harmful medical problem that is severe, dangerous, or requires urgent medical care.
Any participant who has had an adverse event from taking part in study J2T-MC-KGBI cannot join. An adverse event means any unwanted medical problem or side effect that happened during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Evimed Sp. z o.o.	Warsaw	Poland
ICMR (International Center for Medical Research)	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hopitaux Drome Nord	Romans-Sur-Isere	France
Hospital Infantil Universitario Nino Jesus	Madrid	Spain
Hospital De Manises	Manises	Spain
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Fakultni Nemocnice Brno	Brno	Czechia
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Fakultni Nemocnice Bulovka	Prague	Czechia
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Rosenpark Research GmbH	Darmstadt	Germany
Uzzeuacqzqifnqdvyrjbu Mzhewljk Asi	Munster	Germany
Gqozpi Udggfxmwyi Fpgtzoozv	Frankfurt	Germany
Favmgzati Pnfv Lb Iglqdxtdcbnzz Bainfxrat Dws Hczqxlnx Urctxmstilwdm Lx Phb	Madrid	Spain
Cqzjqqm Bonlg Kgzcjebkcnd Pwjcmnai Spp z onkm	Gdansk	Poland
Tztwwsyibtv ulu Sdzawbypciq Bcvdevkx Giis	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.12.2023
France	Not yet recruiting	01.12.2023
Germany	Recruiting	01.12.2023
Poland	Recruiting	01.12.2023
Spain	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Lebrikizumab

Lebrikizumab is the study medicine being tested in this trial. It is given as an injection under the skin and is used to help treat moderate to severe atopic dermatitis, also called eczema. The trial is looking at how safe it is to use over a long time in children and teenagers, and how well it helps control their skin symptoms.

Investigated diseases:

Atopic Dermatitis – Atopic dermatitis, also called eczema, is a long-lasting inflammatory skin disease that causes dry, itchy, and irritated skin. It often begins in childhood and can come and go in flare-ups. The skin may become red, rough, and thickened over time because of repeated scratching and inflammation. In some people, symptoms improve with age, while in others the condition continues for many years.

Trial ID:

2022-501478-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?