Cendakimab for Eosinophilic Esophagitis

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the drug cendakimab interacts with certain enzymes in people with eosinophilic esophagitis (EoE), a condition that inflames the esophagus. The goal is to determine if cendakimab affects how the body processes other drugs. Participants will receive cendakimab along with specific enzyme substrates to study these interactions. Eligible participants have active EoE, have tried heartburn medication without full relief, and track their EoE symptoms daily. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

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

Research has shown that cendakimab is safe for treating eosinophilic esophagitis (EoE), a condition where certain white blood cells accumulate in the esophagus, causing swelling. In earlier studies, patients who took cendakimab experienced noticeable symptom improvements without major safety issues. These studies found that the treatment was well-tolerated over 48 weeks, with no serious side effects linked to the drug. While minor side effects can occur, they were not significant enough to outweigh the benefits observed in these studies.

Overall, cendakimab appears to be a safe option for people with EoE, potentially easing symptoms like difficulty swallowing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eosinophilic esophagitis?

Cendakimab is unique because it targets interleukin-13 (IL-13), a key driver in the inflammation process associated with eosinophilic esophagitis (EoE). Unlike standard treatments like proton pump inhibitors and topical steroids, which primarily aim to reduce symptoms, Cendakimab directly addresses the underlying inflammatory pathway, potentially offering a more targeted approach. Researchers are excited about Cendakimab's potential to provide more effective relief with fewer side effects by honing in on this specific immune response trigger.

What evidence suggests that cendakimab might be an effective treatment for eosinophilic esophagitis?

Research has shown that cendakimab offers significant benefits for people with eosinophilic esophagitis (EoE), a condition where certain white blood cells cause inflammation in the esophagus. Studies have demonstrated that cendakimab reduces the number of these white blood cells and improves symptoms and signs of inflammation. Patients experienced easier swallowing and less discomfort. After 48 weeks of treatment, these improvements persisted, suggesting potential long-term relief. Overall, evidence supports cendakimab as an effective treatment for EoE. In this trial, participants will receive cendakimab alongside Cytochrome P450 (CYP) substrates to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40985784/

Cendakimab in Adults and Adolescents with Eosinophilic ... Conclusions: Cendakimab demonstrated statistically significant improvements in symptoms, histologic response, and endoscopic features of EoE ...

2. eosnetwork.org eosnetwork.org/news/cendakimab-for-eosinophilic-esophagitis-study

Phase 3 Study of Cendakimab for Eosinophilic Oesophagitis ... In a phase 2 study, cendakimab significantly reduced mean oesophagal eosinophil counts and improved other inflammatory parameters in patients with EoE.

3. healio.com healio.com/news/gastroenterology/20241029/cendakimab-sustains-promising-results-for-safety-efficacy-in-eoe-at-48-weeks

Cendakimab sustains 'promising results' for safety ... - Healio A once-weekly 360 mg dose of cendakimab sustained improvements in symptoms and endoscopic/histologic features of eosinophilic esophagitis at 48 weeks.

4. evidence.nejm.org evidence.nejm.org/doi/abs/10.1056/EVIDoa2500095

Cendakimab in Adults and Adolescents with Eosinophilic ... Cendakimab demonstrated statistically significant improvements in symptoms, histologic response, and endoscopic features of EoE versus placebo; ...

5. hcplive.com hcplive.com/view/evan-dellon-md-mph-promising-phase-3-cendakimab-data-eosinophilic-esophagitis

Evan Dellon, MD, MPH: “Promising” Phase 3 Cendakimab ... Cendakimab showed significant improvements in symptoms and esophageal eosinophils in EoE patients over 48 weeks compared to placebo. EoE ...

6. touchimmunology.com touchimmunology.com/insight/cendakimab-in-eosinophilic-oesophagitis/

New data support the efficacy and safety of cendakimab in ... Results from a recent phase 3 clinical trial (NCT04753697), presented at UEG Week 2024, has shown promising results for cendakimab (CEN).