CC-93538 for Eosinophilic Esophagitis

Not currently recruiting at 409 trial locations

Overseen By Paul 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 Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the long-term safety and tolerability of the treatment CC-93538 for individuals with eosinophilic esophagitis (EoE), a condition that inflames the esophagus and makes swallowing difficult. The treatment is administered weekly as an injection. Participants must have been involved in certain earlier studies with CC-93538 and experienced no major issues. It suits those who have previously tried this treatment in past studies and adhered to their dosing schedule. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to the potential availability of a new 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.

Is there any evidence suggesting that CC-93538 is likely to be safe for humans?

Research has shown that CC-93538 has been studied for its safety in treating eosinophilic esophagitis, a condition affecting the esophagus. People generally tolerate this treatment well. A large study tested it against a placebo, a harmless substance with no medical effect, to help researchers assess its safety.

This is a Phase 3 study, indicating that the treatment has already passed earlier safety tests. Phase 3 studies are larger and focus on ensuring the treatment's safety for long-term use. So far, these studies have reported no major safety issues, suggesting that CC-93538 is likely safe for most people. However, like any treatment, some side effects may occur.

Prospective trial participants should discuss any concerns with a doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for eosinophilic esophagitis, such as proton pump inhibitors and corticosteroids, CC-93538 is administered subcutaneously and works by targeting specific pathways involved in the inflammatory process. Researchers are excited about CC-93538 because it blocks the activity of IL-13, a key cytokine involved in the inflammation and tissue damage associated with eosinophilic esophagitis. This targeted approach could potentially offer more effective and longer-lasting relief for patients, with fewer side effects compared to systemic treatments.

What evidence suggests that CC-93538 might be an effective treatment for Eosinophilic Esophagitis?

Research has shown that CC-93538 may help treat eosinophilic esophagitis, a condition where certain white blood cells accumulate in the esophagus. In an earlier study, patients who took CC-93538 weekly for 16 weeks had fewer of these white blood cells in their esophagus, an important measure of the condition's severity. Patients also reported easier swallowing, a common issue with this condition. These findings suggest that CC-93538 can effectively reduce symptoms and inflammation associated with eosinophilic esophagitis. ^{2 3 6 7 8}

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 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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Participants are administered CC-93538 dose subcutaneously once weekly

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

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

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]

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]

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.

8. trials.foodallergy.org trials.foodallergy.org/trials/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 ...