Study on Long-Term Safety of Cendakimab for Adults and Adolescents with Eosinophilic Esophagitis

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment called Cendakimab for individuals with eosinophilic esophagitis. Eosinophilic esophagitis is a condition where a type of white blood cell, called eosinophils, builds up in the esophagus, which can lead to inflammation and difficulty swallowing. The treatment being tested, Cendakimab, is given as a solution for injection under the skin.

The purpose of this study is to evaluate how safe and tolerable Cendakimab is when used over a long period. Participants in the study will receive Cendakimab and will be monitored for any side effects or changes in their health. The study will also look at how the body responds to the treatment, including whether it produces any antibodies against Cendakimab.

Participants in this study include both adults and adolescents who have previously been involved in related studies. The study will continue for several years, allowing researchers to gather comprehensive data on the long-term effects of Cendakimab in treating eosinophilic esophagitis. This information will help determine the safety of using Cendakimab as a treatment option for this condition.

1 joining the study

Participation begins after completing a previous study related to eosinophilic esophagitis. Eligibility is confirmed based on prior study involvement and specific criteria.

A signed informed consent form is required for adults. For adolescents, parental consent and personal assent are necessary.

2 initial assessment

An initial assessment is conducted to ensure no significant adverse events occurred in the previous study that would prevent further participation.

Females of childbearing potential must have a negative pregnancy test before starting the treatment.

3 treatment administration

The treatment involves the administration of cendakimab, a solution for injection, given subcutaneously.

The frequency and dosage are determined by the study protocol, focusing on long-term safety and tolerability.

4 ongoing monitoring

Regular monitoring is conducted to evaluate the safety and tolerability of the treatment. This includes checking for any adverse events, changes in vital signs, and laboratory test results.

The presence of anti-drug antibodies is also assessed to understand the body’s immune response to the treatment.

5 completion of study

The study is expected to continue until August 2026, with regular assessments throughout the duration.

Upon completion, a final evaluation is conducted to summarize the findings related to the long-term safety of the treatment.

Who Can Join the Study?

The patient must have participated in a previous study called Study CC-93538-EE-001 and meet one of the following conditions:
- Had a severe flare-up of eosinophilic esophagitis (EoE) that needed a procedure called an endoscopy or extra treatment during the first part of the study and finished 24 weeks of this phase.
- Finished the first part of the study but did not qualify for the next part for reasons other than a severe EoE flare-up.
- Had a severe EoE flare-up during the second part of the study and finished 48 weeks of this phase.
- Completed 48 weeks of the second part of the study.
Alternatively, the patient must have participated in another study called Study CC-93538-DDI-001 and completed assessments through Week 18 or the end of the treatment visit.
The patient must have followed the required dosing of the study medication in the previous studies and must not have been permanently stopped from taking the study medication.
The patient must not have had any significant negative reactions to the study medication that would prevent further treatment.
Females who can have children must have a negative pregnancy test before starting the study medication and agree to use a highly effective birth control method until 5 months after the last dose of the study medication.
The patient must be 18 years or older and must understand and willingly sign a consent form before any study-related activities. If the patient is under 18, they must agree to participate, and a parent or legal representative must give consent. If a patient under 18 reaches the legal age of consent during the study, they will be asked to sign a consent form themselves to continue in the study. In Austria, Germany, Spain, and Switzerland, patients under 18 will not be enrolled.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or plan to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to medications.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have used certain medications that might affect the study results.
Patients who have a history of drug or alcohol abuse.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Graz	Graz	Austria
Universitaet Leipzig	Leipzig	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Brandenburg an der Havel GmbH	Brandenburg An Der Havel	Germany
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Eb Group Sp. z o.o.	Warsaw	Poland
Azienda Ospedaliera di Padova	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Sint-Lucas General Hospital	Brugge	Belgium
Universita’ Di Pisa	Pisa	Italy
Synexus Polska Sp. z o.o.	Poznan	Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Synexus Clinical Research GmbH	Frankfurt	Germany
Opppcniftgfhwb Lxin Gftz	Linz	Austria
Hahijhls Uceekiefbruro Dw Ly Pabrcuhr	Madrid	Spain
Kjgvxeou Grtggpxtwzixhyuwzgnsjb Gejb	Garmisch-Partenkirchen	Germany
Umowrtsyzy Dissh Sujue Dd Rkxo Ln Soolfcku	Rome	Italy
Wsc Wonfkz Izi Pscej Pqxvwlyy Kwjdkto	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	14.09.2021
Belgium	Not recruiting	14.09.2021
Germany	Not recruiting	14.09.2021
Italy	Not recruiting	14.09.2021
Poland	Not recruiting	14.09.2021
Portugal	Not recruiting	14.09.2021
Spain	Not recruiting	14.09.2021

Trial locations

Investigated drugs:

Cendakimab

CC-93538 is a medication being studied for its long-term safety and tolerability in people with eosinophilic esophagitis, a condition where a type of white blood cell builds up in the esophagus, leading to inflammation and difficulty swallowing. This study aims to understand how safe the medication is for long-term use in both adults and adolescents who have this condition.

Eosinophilic esophagitis – Eosinophilic esophagitis is a chronic immune system disease where a type of white blood cell, called eosinophil, builds up in the lining of the esophagus. This accumulation is often a reaction to foods, allergens, or acid reflux and can lead to inflammation. Over time, the inflammation can cause the esophagus to become narrow, leading to difficulty swallowing and food getting stuck. Symptoms may include heartburn, chest pain, and regurgitation. The condition is more common in males and can occur at any age, but it often begins in childhood. The progression of the disease can vary, with some individuals experiencing periods of remission and others having persistent symptoms.

Trial ID:

2023-506278-10-00

Protocol code:

CC-93538-EE-002

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Term Safety of Cendakimab for Adults and Adolescents with Eosinophilic Esophagitis

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