EOSINOPHILIC ESOPHAGITIS

About the Study

Study Title:

Eosinophilic Esophagitis Research Study

Phase: 3

Study Purpose/Objective:

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.

Study Duration:

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

Study Procedures: 

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 Adverse Event assessments will be performed during the study.

Stipend:  A stipend will be provided to qualified study participants to help defray time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form.

Note: There is no stipend for a Pre-study visit, if such a visit is scheduled.

Eligibility Criteria:

Subjects may be eligible to participate if they meet the below Inclusion Criteria:

1. Subject must be ≥ 12 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb)
2. Subject has clinically confirmed histologic evidence of EoE.
3. Subject has symptoms of dysphagia over the last 2 consecutive weeks (14 days) prior to Day 1.
4. Subject must have previously had an inadequate response to proton-pump inhibitor (PPI) medication.
5. 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.
6. 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.
7. Female subjects of childbearing potential must agree to practice a highly effective method of contraception.
8. Subject is willing to receive weekly SC injections throughout the study.

Subjects would not be eligible to participate if they meet any of the below Exclusions Criteria which includes but is not limited to:

1. 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.).
2. Subject demonstrates presence of esophageal varices.
3. Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition.
4. 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).
5. 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.
6. Subject demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs.
7. 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.
8. 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).
9. Subject has an ongoing infection (eg, hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines.
10. Subject is pregnant or lactating.
21. 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.