Cendakimab for Eosinophilic Esophagitis

Recruiting at 27 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celgene

Must not be taking: Anticoagulants, Immunosuppressants, Corticosteroids

Disqualifiers: Immunosuppression, others

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

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing how a medication called cendakimab interacts with other drugs in people who have a condition affecting the esophagus. The goal is to see if cendakimab changes how these other medications work in the body.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on blood thinners, immunosuppressive drugs, or high potency topical steroids for skin conditions.

How is the drug Cendakimab different from other treatments for eosinophilic esophagitis?

Cendakimab is unique because it targets the interleukin-13 (IL-13) pathway, which is a key driver of eosinophilic esophagitis, unlike other treatments that may focus on dietary changes or general anti-inflammatory approaches. This specific targeting could potentially offer more effective relief for patients by directly addressing the underlying allergic inflammation. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with active Eosinophilic Esophagitis (EoE) who didn't fully respond to proton-pump inhibitors. Participants should have documented symptoms and a certain number of eosinophils in the esophagus. Those using high potency steroids, immunosuppressive drugs, or on anticoagulation therapy cannot join.

Inclusion Criteria

I have active Eosinophilic esophagitis with a high eosinophil count in my esophagus.

EoE symptoms documented in daily diary during the screening period

I tried acid reflux medication for my EoE, but it didn't fully work.

Exclusion Criteria

I am using a strong prescription cream for my skin condition.

I am currently on blood thinners for treatment.

I am on drugs that affect my immune system or have evidence of being immunosuppressed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cendakimab and selected Cytochrome P450 substrates to evaluate potential disease-mediated drug-drug interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cendakimab
• CYP substrates

Trial Overview The study is testing how Cendakimab interacts with other drugs metabolized by the body's enzymes in people with EoE. It aims to understand if having EoE changes the way Cendakimab affects these other medications.

Participant Groups

Group I: Administration of Cendakimab and Cytochrome P450 (CYP) substrates Experimental Treatment 2 Interventions

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

Findings from Research

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 (EoE) is now recognized as a distinct disease driven by allergic inflammation, particularly linked to IL-13 signaling, rather than being solely caused by acid reflux, as shown by various studies including transcriptomic profiling.

Dupilumab, an anti-IL-13 and IL-4 receptor monoclonal antibody, has been approved by the FDA for EoE, demonstrating significant improvements in clinical and molecular features of the disease, marking a significant advancement in treatment options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific journey to the first FDA-approved drug for eosinophilic esophagitis. Rothenberg, ME.[2023]

In a study of 12 patients with eosinophilic gastritis (EoG) and/or eosinophilic duodenitis (EoD), dupilumab treatment led to symptom improvement in all patients, with 40% of EoG patients and 33.3% of EoD patients becoming completely asymptomatic.

Histologically, dupilumab significantly reduced eosinophil counts in the stomach and duodenum, achieving histologic remission in 100% of EoG patients and 66.6% of EoD patients, suggesting it may be an effective treatment for non-EoE-EGIDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. Sia, T., Bacchus, L., Tanaka, R., 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Case Series on the Use of Dupilumab for Treatment of Refractory Eosinophilic Gastrointestinal Disorders. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Scientific journey to the first FDA-approved drug for eosinophilic esophagitis. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

First Therapeutic Approval for Eosinophilic Esophagitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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