Celgene - Do you have Eosinophilic Esophagitis and difficulty swallowing?

Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE) is a chronic, allergic, inflammatory disorder of the oesophagus. EoE is usually caused by something in the diet, or something that has been inhaled, which triggers an allergic reaction resulting in swelling of the oesophagus. This inflammation usually results in difficulty swallowing. Other symptoms of EoE may include a feeling that food is stuck between the throat and stomach, chest pain, or upper abdominal pain. Additionally, a laboratory test will show a type of white blood cell, called an ‘eosinophil’, to be present in the oesophagus in large numbers, which is not normal.

The study treatment is called CC-93538 (also known as cendakimab). CC-93538 is an antibody, which is made in a laboratory and designed to stop the body’s immune system from triggering the allergic reaction.

The study evaluates the safety and effectiveness of CC-93538 for treatment of EoE and relief of swallowing difficulties.

Category
Inflammatory Bowel Disease
Trial status
Active, not recruiting
Trial phase
Phase 3 Drug Trial
Late stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
Registry listing
ClinicalTrials.gov: NCT04753697

Trial contact details

Contact person
IBD Clinical Trials Unit
Email
ibdtrials.coordinator@mater.uq.edu.au
Phone
07 3163 8195

What you need to know

Who can take part?

Participants aged 12 -75
Body weight of ≥ 40 kg
Biopsy evidence of Eosinic Esophagitis
Difficulty swallowing
Must have had inadequate response to previous treatments
Willing to maintain stable diet
Willing to receive weekly injections

Exclusion

Participants with certain other diseases may be excluded from participating
Pregnant or breastfeeding women may not participate
Current infection
Immunosupression
Some medications may make you ineligible to participate

What is involved for you?

Participants will be randomly assigned to receive the investigational treatment or placebo in addition to standard medical care. They will also undergo the following tests and procedures: