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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04991935
Registration number
NCT04991935
Ethics application status
Date submitted
28/07/2021
Date registered
5/08/2021
Date last updated
10/05/2024
Titles & IDs
Public title
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
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Scientific 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
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Secondary ID [1]
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2020-004335-24
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Secondary ID [2]
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CC-93538-EE-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Inflammatory and Immune System
0
0
0
0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CC-93538
Experimental: Administration of CC-93538 - Participants are administered CC-93538 dose subcutaneously once weekly
Treatment: Drugs: CC-93538
CC-93538
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Adverse Events (AEs)
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Assessment method [1]
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An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
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Timepoint [1]
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For a minimum of 28 months
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Secondary outcome [1]
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Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies
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Assessment method [1]
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This includes neutralizing antibodies when warranted.
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Timepoint [1]
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For a minimum of 28 months
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Eligibility
Key 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.
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Minimum age
12
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/09/2026
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Actual
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Sample size
Target
259
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Accrual to date
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Final
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Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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The Childrens Hospital at Westmead - Westmead
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St John of God Midland Hospital - Western Australia
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2139 - Concord
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2170 - Liverpool
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2145 - Westmead
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4101 - South Brisbane
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5000 - Adelaide
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05112 - Elizabeth Vale
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3168 - Clayton
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3011 - Footscray
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3004 - Melbourne
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6150 - Murdoch
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3065 - Fitzroy
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6056 - Western Australia
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United Kingdom
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State/province [114]
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Cardiff
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Country [115]
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United Kingdom
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State/province [115]
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Chorley
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Country [116]
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United Kingdom
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State/province [116]
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Hardwick
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Country [117]
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United Kingdom
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State/province [117]
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Hexam
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Country [118]
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United Kingdom
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State/province [118]
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Liverpool
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Country [119]
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United Kingdom
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State/province [119]
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Manchester
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Country [120]
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United Kingdom
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State/province [120]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04991935
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Phone
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855-907-3286
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04991935
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