"A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis"

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celgene International II S.a.r.l.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trial duration

22 Apr 2022 → 14 Aug 2025

Decision date (initial)

2024-04-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Celgene Corporation

External identifiers

EU CT number

2023-506278-10-00

EudraCT number

2020-004335-24

WHO UTN

U1111-1259-1126

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To evaluate the long-term safety and tolerability of CC-93538 in subjects with eosinophilic esophagitis (EoE).

Secondary objectives 1

1. To characterize the immunogenicity profile of CC-93538 following longterm treatment

Conditions and MedDRA coding

Eosinophilic esophagitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1 a. Subject must have participated in Study CC-93538-EE-001, and meets one of the following criteria: 1) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR 2) Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR 3) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR 4) Subject completed Week 48 of the Maintenance Phase b. OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments in Period 2 through Week 18/End of Treatment Visit
2. 2. Demonstrated compliance with required investigational product dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI001 and subject must not have been permanently discontinued from IP while participating in Study CC-93538-EE-001 or Study CC-93538-DDI001.
3. 3. Subjects must have not experienced any clinically significant adverse events related to Investigational Product that would preclude further dosing.
4. 4. Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study)until 5 months after the last dose of open-label CC-93538.
5. 5. Subject (18 years of age or older) must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to signan ICF (called a Transitional ICF) themselves to acknowledge their willingness to continue in the study. In Austria, Germany, Spain, and Switzerland, adolescent subjects will not be enrolled.

Exclusion criteria 11

1. "1. Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
2. 2. Subject demonstrates presence of esophageal varices.
3. 3. Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition
4. 4. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-livesprior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
5. 5. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
6. 6. Received an investigational product, other than that administered in CC-93538-EE-001 or Study CC-93538-DDI-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 or Study CC93538-DDI-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician.
7. 7. Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
8. 8. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, a documented medical diagnosis of gastritis, which is clinically significant in the judgment of the Investigator; colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE).
9. 9. Active or ongoing infections including parasitic/helminthic infections
10. 10. Subject has a chronic infection (eg, hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines).
11. 11. Females who are pregnant or lactating

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities.

Secondary endpoints 1

1. Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies to CC-93538 including neutralizing antibodies when warranted.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene International II S.a.r.l.

Sponsor organisation

Celgene International II S.a.r.l.

Address

Route De Perreux 1

City

Boudry

Postcode

2017

Country

Switzerland

Scientific contact point

Organisation

Celgene International II S.a.r.l.

Contact name

GSM-CT

Public contact point

Organisation

Celgene International II S.a.r.l.

Contact name

GSM-CT

Third parties 11

Locations

7 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 84 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications