Clinical trial NCT04991935: Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
CC-93538
RPC4046
Adult
Adolescent
Gastrointestinal Diseases
Esophagitis
Gastroenteritis
Eosinophils
Eosinophilia
Esophageal Diseases
Allergic Diseases
Antibody, Monoclonal
Hypersensitivity
Immunologic factors
Physiological Effects of Drugs
Cendakimab
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 259
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.


Eligibility criteria: Inclusion Criteria:

* Previously participated in prior clinical study CC-93538-EE-001 and either:

  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
* OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit
* 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.
* 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.

Exclusion Criteria:

* Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
* Active Helicobacter pylori infection or esophageal varices.
* Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
* Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
* Received an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, 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 the CC-93538-EE-001 or CC-93538-DDI-001 studies are not eligible to participate, unless allowed following a discussion with the Clinical Trial Physician.
* 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.
* 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, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
* Active parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (viral hepatitis, tuberculosis, or HIV)
* Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
* Females who are pregnant or lactating.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: For a minimum of 28 months
Secondary outcomes:
measure: Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies
timeFrame: For a minimum of 28 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 144
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 082
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 147
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution - 041
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 029
state: Arizona
city: North Little Rock
country: United States
facility: Local Institution - 165
state: Arkansas
city: Lancaster
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Aurora
country: United States
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state: Colorado
city: Colorado Springs
country: United States
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state: Colorado
city: Wheat Ridge
country: United States
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state: Colorado
city: Bristol
country: United States
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state: Connecticut
city: Farmington
country: United States
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state: Connecticut
city: Hamden
country: United States
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state: Connecticut
city: Clearwater
country: United States
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state: Florida
city: Inverness
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Miami
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state: Florida
city: Orlando
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state: Florida
city: Pinellas Park
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state: Florida
city: Plantation
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state: Florida
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state: Florida
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state: Georgia
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state: Georgia
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state: Georgia
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state: Illinois
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state: Illinois
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state: Iowa
city: Iowa City
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state: Iowa
city: Kansas City
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state: Kansas
city: Florence
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state: Kentucky
city: Baton Rouge
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state: Louisiana
city: Metairie
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state: Louisiana
city: Metairie
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state: Louisiana
city: Columbia
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state: Maryland
city: Glen Burnie
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state: Maryland
city: Hagerstown
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state: Maryland
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state: Massachusetts
city: South Dartmouth
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state: Massachusetts
city: Worcester
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state: Michigan
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state: Minnesota
city: Rochester
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state: Minnesota
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state: Missouri
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state: Missouri
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state: Nebraska
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state: New Hampshire
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state: New Mexico
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state: New York
city: New York
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state: New York
city: Syracuse
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state: New York
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state: New York
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state: North Carolina
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state: North Carolina
city: Greensboro
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state: Ohio
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state: Oklahoma
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
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state: Tennessee
city: Nashville
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state: Tennessee
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state: Texas
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state: Texas
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state: Texas
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state: Texas
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state: Texas
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state: Texas
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facility: Local Institution - 125
state: Utah
city: Lynchburg
country: United States
facility: Local Institution - 013
state: Virginia
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state: Virginia
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facility: Local Institution - 023
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state: Alberta
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state: Alberta
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state: Alberta
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state: British Columbia
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state: British Columbia
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state: Ontario
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state: Ontario
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city: Brandenburg an der Havel
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city: Frankfurt am Main
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facility: Local Institution - 337
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facility: Local Institution - 280
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facility: Local Institution - 282
city: Zerifin
country: Israel
facility: Local Institution - 279
city: Genova
country: Italy
facility: Local Institution - 257
city: Milano
country: Italy
facility: Local Institution - 254
city: Padova
country: Italy
facility: Local Institution - 255
city: Pisa
country: Italy
facility: Local Institution - 252
city: Rome
country: Italy
facility: Local Institution - 253
city: Nishinomiya
country: Japan
facility: Local Institution - 600
state: Hyogo
city: Bunkyo-ku
country: Japan
facility: Local Institution - 595
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Local Institution - 599
state: Tokyo
city: Akita-shi
country: Japan
facility: Local Institution - 593
city: Isehara City, Kanagawa
country: Japan
facility: Local Institution - 606
city: Kobe
country: Japan
facility: Local Institution - 597
city: Maebashi
country: Japan
facility: Local Institution - 598
city: Nagoya
country: Japan
facility: Local Institution - 607
city: Okayama-Shi
country: Japan
facility: Local Institution - 603
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 602
city: Tokyo
country: Japan
facility: Local Institution - 605
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country: Japan
facility: Local Institution - 590
city: Bydgoszcz
country: Poland
facility: Local Institution - 385
city: Częstochowa
country: Poland
facility: Local Institution - 389
city: Gdansk
country: Poland
facility: Local Institution - 390
city: Katowice
country: Poland
facility: Local Institution - 388
city: Lódz
country: Poland
facility: Local Institution - 392
city: Warsaw
country: Poland
facility: Local Institution - 383
city: Warszawa
country: Poland
facility: Local Institution - 387
city: Warszawa
country: Poland
facility: Local Institution - 393
city: Wroclaw
country: Poland
facility: Local Institution - 391
city: Wroclaw
country: Poland
facility: Local Institution - 384
city: Lisboa
country: Portugal
facility: Local Institution - 307
city: Lisboa
country: Portugal
facility: Local Institution - 305
city: Porto
country: Portugal
facility: Local Institution - 306
city: Porto
country: Portugal
facility: Local Institution - 308
city: Barcelona
country: Spain
facility: Local Institution - 408
city: Cordoba
country: Spain
facility: Local Institution - 410
city: Madrid
country: Spain
facility: Local Institution - 409
city: Madrid
country: Spain
facility: Local Institution - 413
city: Marbella
country: Spain
facility: Local Institution - 411
city: Sevilla
country: Spain
facility: Local Institution - 412
city: Lausanne
country: Switzerland
facility: Local Institution - 357
city: Belfast Northern Ireland
country: United Kingdom
facility: Local Institution - 228
city: Birmingham
country: United Kingdom
facility: Local Institution - 231
city: Cardiff
country: United Kingdom
facility: Local Institution - 234
city: Chorley
country: United Kingdom
facility: Local Institution - 235
city: Hexam
country: United Kingdom
facility: Local Institution - 233
city: Liverpool
country: United Kingdom
facility: Local Institution - 236
city: Manchester
country: United Kingdom
facility: Local Institution - 237
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: