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Compensation: Varies

Number of Visits: Unknown

Duration: 28 months

259 Participants Needed

CC-93538 for Eosinophilic Esophagitis

Recruiting at 393 trial locations

Overseen ByPaul Feuerstadt, Site 156

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Must not be taking: Immunosuppressives, Immunotherapies, others

Disqualifiers: Helicobacter pylori, Immunosuppression, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial aims to evaluate the ongoing safety and tolerability of CC-93538 in participants who were part of earlier studies involving this treatment.

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

The trial requires that you do not take certain medications, such as systemic immunosuppressive drugs or oral immunotherapy, before and during the study. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the drug CC-93538 for Eosinophilic Esophagitis?

While there is no direct data on CC-93538, similar treatments like omalizumab and dupilumab have shown some effectiveness in reducing inflammation and symptoms in eosinophilic esophagitis and other eosinophilic disorders. Omalizumab reduced inflammation in some patients, and dupilumab helped achieve remission in patients with eosinophilic gastrointestinal disorders.¹ ² ³ ⁴ ⁵

How is the drug CC-93538 different from other treatments for eosinophilic esophagitis?

CC-93538 is unique because it is an anti-interleukin-5 monoclonal antibody, which targets specific immune pathways involved in eosinophilic esophagitis, unlike traditional treatments that focus on dietary changes and corticosteroids.³ ⁴ ⁶ ⁷ ⁸

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults and adolescents who have Eosinophilic Esophagitis (EoE) and were part of previous CC-93538 studies. They must not have other conditions that could affect the study, no severe allergies to ingredients in CC-93538, no recent immunotherapy or live vaccines, and women must test negative for pregnancy and use contraception.

Inclusion Criteria

Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.

Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.

I am not pregnant and agree to use effective birth control during and for 5 months after treatment.

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Exclusion Criteria

I have not taken any immune-weakening drugs recently.

I haven't taken any experimental drugs recently, except for those in specific studies.

I do not have any health conditions that could interfere with the study or increase my risk by participating.

See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-93538 subcutaneously once weekly

28 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive CC-93538 to evaluate long-term safety and tolerability

Long-term

Treatment Details

Interventions

CC-93538

Trial Overview The trial tests the long-term safety of a drug called CC-93538 in patients with EoE who participated in earlier related trials. It's an open-label study, meaning everyone knows they're getting the drug, without a comparison group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Administration of CC-93538Experimental Treatment1 Intervention

Participants are administered CC-93538 dose subcutaneously once weekly

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Findings from Research

In a pilot study of 15 patients with Eosinophilic Esophagitis (EoE), treatment with the anti-IgE drug omalizumab for 12 weeks significantly reduced tissue IgE levels and showed a correlation between decreased eosinophils and clinical improvement, although full remission was achieved in only 33% of patients.

The study suggests that omalizumab may be effective for EoE in patients with low peripheral blood eosinophil counts, highlighting the need for further research to confirm these findings in a larger, controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of omalizumab in eosinophilic esophagitis.Loizou, D., Enav, B., Komlodi-Pasztor, E., et al.[2018]

Dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, showed promising results in achieving clinical and histopathologic remission in three pediatric patients with non-eosinophilic esophagitis gastrointestinal disorders (EGID) who did not respond to standard treatments.

This study suggests that dupilumab may be a potential new treatment option for pediatric patients with eosinophilic gastrointestinal disorders, as it effectively reduced mucosal eosinophilia in multiple segments of the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Series on the Use of Dupilumab for Treatment of Refractory Eosinophilic Gastrointestinal Disorders.Patel, N., Goyal, A., Thaker, A., et al.[2023]

Eosinophilic esophagitis is a chronic disorder that mimics GERD symptoms but does not respond to anti-GERD treatments; effective management includes dietary restrictions and topical corticosteroids.

Current research is exploring anti-interleukin-5 monoclonal antibodies as a potential treatment, aiming to target the underlying causes of esophageal remodeling and fibrosis associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pediatric eosinophilic esophagitis: an update.Khan, S.[2021]