CC-93538 for Eosinophilic Esophagitis

Recruiting at 468 trial locations

Overseen By Julien Fahed, Site 121

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Must not be taking: Systemic corticosteroids, Immunosuppressives

Disqualifiers: Gastrointestinal disorders, Immunosuppression, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

399 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: Placebo for Induction and Maintenance CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance CC-93538 360 mg SC once weekly for Induction and Maintenance

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Adults and adolescents aged 12-75 with a body weight over 40 kg, diagnosed with eosinophilic esophagitis (EoE), showing specific levels of eosinophils in the esophagus. They must have had symptoms like difficulty swallowing and not fully responded to acid reflux medication. Stable doses of certain other medications are required, and females capable of childbearing need negative pregnancy tests and must use contraception.

Inclusion Criteria

I have had 2 negative pregnancy tests and will use effective birth control until 5 months after my last treatment dose.

I have been on a stable dose of certain asthma or skin medications for at least 4 weeks.

I have been on a stable dose of proton pump inhibitor for 4 weeks without complete relief.

Exclusion Criteria

I have taken medication for EoE by swallowing it in the last 4 weeks.

I have other health conditions that could affect this study's tests.

I haven't used strong skin creams or oral steroids in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive CC-93538 or placebo subcutaneously once weekly for 24 weeks

24 weeks

Maintenance

Participants continue with CC-93538 or placebo, with dosing frequency adjusted to once every other week for some arms

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CC-93538
• Placebo

Trial Overview The trial is testing CC-93538's effectiveness for EoE treatment against a placebo. Participants will be randomly assigned to receive either CC-93538 or a placebo during a 24-week Induction Phase followed by a Maintenance Phase. The drug is administered subcutaneously once weekly or every other week depending on the phase.

How Is the Trial Designed?

Group I: Administration of CC-93538 and Placebo Experimental Treatment 2 Interventions

CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks. During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.

Group II: Administration of CC-93538 Experimental Treatment 1 Intervention

CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks

Group III: Administration of Placebo Placebo Group 1 Intervention

Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania