A study to evaluate the long-term safety and effectiveness of afimkibart in patients with atopic dermatitis who took part in previous afimkibart studies

2 1

What is this study about?

This study is looking at Atopic Dermatitis, which is a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called Afimkibart, also known by its code name RO7790121, which is given as an injection under the skin. Some participants will receive RO7790121 while others will receive placebo. This study is designed for people who have already taken part in earlier studies testing this same medication.

The purpose of this study is to evaluate the long-term safety and how well the treatment works over an extended period of time. The study will track any unwanted effects that might occur and will measure how the condition responds to the treatment. Participants will continue receiving the medication they were assigned in the previous study and will attend regular visits where doctors will examine their skin and ask questions about their symptoms and quality of life.

During the study, doctors will check for any side effects and measure how much the skin condition improves. They will look at the area of skin affected and how severe the symptoms are, as well as how much the condition impacts daily life activities. Blood samples will be taken to measure the amount of medication in the body and to check if the body develops any reaction to the treatment. The study will also track changes in general health measures to ensure the treatment remains safe over time.

1 Entry into extension study

Upon completing the treatment period of the previous study, you will transition into this extension study.

This study will evaluate the long-term safety and effectiveness of afimkibart (also known as RO7790121) for treating atopic dermatitis.

The study is expected to run until December 2033.

2 Treatment administration

You will receive afimkibart or placebo (an inactive substance that looks like the medication but contains no active ingredient).

The medication will be administered as a subcutaneous injection, which means it will be injected under the skin.

The medication is provided as a solution for injection.

3 Regular study visits and assessments

You will attend regular study visits throughout the duration of the study.

At each visit, your skin condition will be assessed using the Eczema Area and Severity Index (a measurement that evaluates the extent and severity of your eczema).

Your doctor will also use the Validated Investigator Global Assessment Scale for Atopic Dermatitis to rate the overall severity of your skin condition on a scale where 0 means clear skin and 1 means almost clear skin.

4 Questionnaire completion

You will be asked to complete questionnaires about how your skin condition affects your daily life.

The Dermatology Life Quality Index measures how much your skin problem has affected your life over the past week.

The Patient-Oriented Eczema Measure asks about your experience with eczema symptoms over the past week.

These questionnaires will be completed at each study visit.

5 Safety monitoring

Throughout the study, you will be monitored for any side effects or health changes.

Your vital signs (such as blood pressure, heart rate, and temperature) will be measured regularly.

Blood samples will be collected at specified times to check your general health through laboratory tests.

Any adverse events, including serious health problems or side effects that lead to stopping the treatment, will be recorded and assessed.

6 Blood sample collection for medication levels

Blood samples will be collected at specific timepoints to measure the amount of afimkibart in your bloodstream.

These samples will also check for the presence of anti-drug antibodies, which are proteins your body might produce in response to the medication.

The presence and levels of neutralizing antibodies (antibodies that might reduce the effectiveness of the medication) will also be measured.

7 Contraception requirements

You will need to follow specific contraception requirements during the study.

This is a safety measure that applies throughout your participation in the study.

8 Ongoing participation

You are expected to comply with all aspects of the study protocol throughout the entire duration.

This includes attending all scheduled visits, completing all assessments and questionnaires, and providing blood samples as required.

The study will continue for several years to evaluate the long-term safety and effectiveness of the treatment.

Who Can Join the Study?

You must be willing and able to follow all parts of the study plan, including completing EASI (a scoring system that measures the extent and severity of skin redness, thickness, scratching, and affected body area) and IGA (a doctor’s assessment of the overall severity of your skin condition) assessments, questionnaires about quality of life called DLQI and POEM (which measure how your skin condition affects your daily activities), and providing blood samples for safety checks and to measure drug levels throughout the entire study
You must agree to follow the required birth control methods during the study
You must have finished the full treatment period in the previous study (called the parent study) before joining this study

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are conditions or factors that would prevent someone from joining this clinical trial
Without detailed exclusion criteria listed, it is not possible to specify which patients cannot participate in this study
Typically, exclusion criteria may include things like other medical conditions, certain medications being taken, pregnancy status, or previous treatments, but none are specified in the available information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland
Hospital Universitario De Navarra	Pamplona	Spain
Royalderm Agnieszka Nawrocka	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Dermatologikum Hamburg GmbH	Hamburg	Germany
Harzklinikum Dorothea Christiane Erxleben GmbH	Quedlinburg	Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen	Chemnitz	Germany
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Pratia S.A.	Skorzewo	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hopital Beaujon	Clichy	France
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki	Szczecin	Poland
Mesriudzv Ijukoifdeo Chdovsgo Snivhbrs Sfg z ogsy	Warsaw	Poland
Tczhgpvakpn uvd Ssdtbdiqzld Bmnlgatz Gjyo	Bad Bentheim	Germany
Hkaxodag Dr Lp Sbpxe Cznf I Sjnl Psg	Barcelona	Spain
Fuchvtqay Pmzb Lv Iqtivtafktdkz Bjestcrwx Dbe Hpmwponc Uzhbldsnbxtje Lt Pzz	Madrid	Spain
Wfu Wechrp Iiz Panfi Pyhegvwg Kifyuzs	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	03.03.2026
Germany	Recruiting	03.03.2026
Italy	Not yet recruiting	03.03.2026
Poland	Recruiting	03.03.2026
Spain	Not yet recruiting	03.03.2026

Trial locations

Investigated drugs:

Ro7790121

Afimkibart is a medication being tested to treat atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin. This medicine is designed to help control the symptoms of this condition over a long period of time. In this study, researchers want to see if the medication is safe to use for an extended time and if it continues to work well for people who have already tried it in earlier studies.

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes the skin to become red, itchy, and dry. It often appears in childhood but can occur at any age, affecting various parts of the body including the face, hands, feet, and skin folds. The condition tends to flare up periodically, with symptoms worsening during certain times and improving during others. During flare-ups, the affected skin may develop small, raised bumps that can leak fluid and crust over when scratched. The intense itching often leads to scratching, which can further damage the skin and increase the risk of skin infections. The condition follows a pattern of remission and relapse throughout a person’s life, with varying degrees of severity.

Trial ID:

2025-520771-59-00

Protocol code:

CS45943

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study to evaluate the long-term safety and effectiveness of afimkibart in patients with atopic dermatitis who took part in previous afimkibart studies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?