Eosinophilic Esophagitis Research Study

  • STATUS
    Recruiting
  • sponsor
    Celgene International
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Updated on 14 January 2022
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Summary

The purpose of this study is to see if CC-93538 is safe and effective as a possible treatment for EoE. To do this, a comparison will be made between subjects who receive CC-93538 and subjects who receive a placebo (a ‘dummy treatment’ that looks like CC-93538 but contains no active ingredient). The purpose of this Phase 3 study is to help confirm the earlier results from a completed Phase 2 study, which suggests that CC-93538 may be safe and effective in treating patients with EoE. 

Description

This study will consist of a 24-week Induction Phase followed by a 24-week Maintenance Phase.
The study is divided into 4 periods of time:
  • A 4-8 week Screening Period
  • A 24-week Induction Phase
  • A 24-week Maintenance Phase
  • And a 16-week Safety Follow-Up Period
Clinical laboratory tests, vital signs, physical examinations (including height and weight),pregnancy tests, esophagogastroduodenoscopy (EGD), clinical symptom assessments, subject reported outcomes, serum CC-93538 concentrations, serum antibodies to CC-93538 (to assess immunogenicity), concomitant medications, and AE assessments will be performed during the study.

Details
Condition Gastrointestinal Diseases and Disorders
Clinical Study IdentifierTX290682
SponsorCelgene International
Last Modified on14 January 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

\. Subject must be ≥ 12 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb)
\. Subject has clinically confirmed histologic evidence of EoE
\. Subject has symptoms of dysphagia over the last 2 consecutive weeks (14 days) prior to Day 1
\. Subject must have previously had an inadequate response to proton-pump inhibitor (PPI) medication
\. Subject must either (1) be naïve or have had an adequate response to corticosteroid therapy (ie, classified as Steroid Responders/Naïve) or (2) have had an inadequate response to corticosteroid therapy and is not considered to be a candidate for continued corticosteroid therapy, or is intolerant to corticosteroid therapy
\. Subjects must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or EoE) from the first Screening Visit and throughout the duration of the study, and subjects must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit. Subjects must agree not to introduce any changes in their diet while participating in the study
\. Female subjects of childbearing potential must agree to practice a highly effective method of contraception
\. Subject is willing to receive weekly SC injections throughout the study

Exclusion Criteria

Subject has clinical or endoscopic evidence of the presence of any other disease that may interfere with or affect the histologic, endoscopic, and clinical symptom endpoints for this study (eg, erosive esophagitis Los Angeles [LA] classification Grade B or above, Barrett's esophagus, esophageal lichen planus, upper gastrointestinal bleed, achalasia, inflammatory bowel disease, diagnosed eosinophilic gastroenteritis [clinical symptoms and/or EGD findings and confirmatory eosinophilia in gastric and/or duodenal mucosa], or significant hiatal hernia [> 3 cm], etc.)
Subject demonstrates presence of esophageal varices
Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition
Subject has evidence of a severe endoscopic structural abnormality in the esophagus (eg, high-grade stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of the screening EGD)
Subject had esophageal dilation for symptom relief during the Screening Period or within 8 weeks prior to the first Screening Visit, or esophageal dilation is anticipated to be performed within 48 weeks of dosing during the study
Subject demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
Subject is currently successfully treated for EoE with dietary modifications (eg, food elimination diet) and is able to fully adhere to the diet resulting in a complete response to EoE
Subject has any other disease that would make conduct of the protocol or interpretation of the study results difficult or that would put the prospective subject at risk by participating in the study (eg, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, gastritis, colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE)
Subject has an ongoing infection (eg, hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines
Subject is pregnant or lactating
Subject has a history of cancer or lymphoproliferative disease, other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or adequately treated cervical carcinoma in situ, within 5 years of screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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