CC-93538 for Eosinophilic Esophagitis

Not currently recruiting at 485 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called CC-93538 to determine its effectiveness for people with eosinophilic esophagitis (EoE), a condition that makes swallowing difficult. Participants will receive either the new drug or a placebo (a substance with no active medicine) to compare the treatment's effectiveness over 48 weeks. It suits those with EoE that hasn't improved with other treatments and who experience difficulty swallowing four or more times in two weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications before joining the trial. If you are taking a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, you must stop at least 4 weeks before the first screening visit. However, if you are on a stable dose of a proton pump inhibitor or certain other medications for different conditions, you can continue them during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CC-93538 has been tested for safety and tolerability. In one study, adults and teenagers received the treatment over an extended period. This study was "open-label," meaning all participants knew the treatment being used. The goal was to assess how participants managed the treatment over time.

Although detailed information on side effects is not available, the progression of CC-93538 to a Phase 3 trial suggests earlier studies found it generally safe. Before reaching this stage, treatments typically need to demonstrate sufficient safety in smaller groups.

The current trials aim to confirm these findings in a larger group and gather more information on any possible side effects. For those considering joining this trial, it is reassuring that no major safety issues have halted its progress so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for eosinophilic esophagitis, which typically include dietary management, proton pump inhibitors, and topical steroids, CC-93538 is a monoclonal antibody that targets the cytokine IL-13. This unique approach aims to reduce inflammation in the esophagus by directly interfering with a pathway that contributes to the disease. Researchers are excited about CC-93538 because it offers a targeted treatment that could provide more effective relief for patients with fewer systemic side effects. Additionally, its subcutaneous administration may offer a more convenient option for patients compared to current treatments.

What evidence suggests that this trial's treatments could be effective for eosinophilic esophagitis?

Research has shown that CC-93538 may help treat eosinophilic esophagitis (EoE). In earlier studies, patients using CC-93538 had fewer eosinophils (a type of white blood cell) in their esophagus, a key sign of EoE. They also reported feeling better, with less trouble swallowing. This suggests that CC-93538 might ease EoE symptoms by reducing inflammation in the esophagus. In this trial, participants will receive CC-93538 as a weekly injection under the skin, a method proven effective in past research. This offers hope that CC-93538 can provide significant relief for people with this condition. ^{2 3 5 6 7}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04753697

A Study to Evaluate the Efficacy and Safety of CC-93538 in ... Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the ...

2. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT04753697

Trial ID CC-93538-EE-001 | NCT04753697 - BMS Clinical Trials Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20520133

A Study to Evaluate the Effectiveness and Safety of CC ... The purposes of this study are to assess the effectiveness of CC-93538 versus placebo in reducing dysphagia symptoms at 24 weeks, and to assess ...

4. bmsstudyconnect.com bmsstudyconnect.com/es/en/clinical-trials/NCT04991935.html

Safety Study of CC-93538 in Adult and Adolescent ... This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1910/phase-3-multi-center-multi-national/

Clinical Research Studies - NYU CC-93538 180 mg and 360 mg subcutaneously (SC) weekly for 16 weeks reduced the mean esophageal eosinophil count (the primary endpoint) and improved other ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04991935

NCT04991935 | Safety Study of CC-93538 in Adult and ... This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.

7. mountsinai.org mountsinai.org/clinical-trials/safety-study-of-cc-93538-in-adult-adolescent-participants-with-eosinophilic-esophagitis

Safety Study of CC-93538 in Adult and Adolescent ... Summary: This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.