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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04753697




Registration number
NCT04753697
Ethics application status
Date submitted
5/02/2021
Date registered
15/02/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Scientific title
A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.
Secondary ID [1] 0 0
U1111-1263-4351
Secondary ID [2] 0 0
CC-93538-EE-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-93538
Other interventions - Placebo

Experimental: Administration of CC-93538 - CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks

Experimental: Administration of CC-93538 and Placebo - CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks.

During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.

Placebo comparator: Administration of Placebo - Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks


Treatment: Drugs: CC-93538
Subcutaneous

Other interventions: Placebo
Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in DD Clinical Response
Timepoint [1] 0 0
At week 24
Primary outcome [2] 0 0
Eosinophil Histologic Response (= 6/hpf)
Timepoint [2] 0 0
At week 24
Secondary outcome [1] 0 0
Eosinophil Histologic Response (< 15/hpf)
Timepoint [1] 0 0
At week 24
Secondary outcome [2] 0 0
EoE Endoscopic Reference Score (EREFS)
Timepoint [2] 0 0
At week 24
Secondary outcome [3] 0 0
EoEHSS Grade Score
Timepoint [3] 0 0
At week 24
Secondary outcome [4] 0 0
EoEHSS Stage Score
Timepoint [4] 0 0
At week 24
Secondary outcome [5] 0 0
mDSD Composite Score
Timepoint [5] 0 0
At week 24
Secondary outcome [6] 0 0
DD Clinical Responder Definition
Timepoint [6] 0 0
At week 24
Secondary outcome [7] 0 0
Kinetics and Onset of Clinical Response_DD
Timepoint [7] 0 0
Through week 24
Secondary outcome [8] 0 0
Kinetics and Onset of Clinical Response_mDSD
Timepoint [8] 0 0
Through week 24
Secondary outcome [9] 0 0
Time to Event _EoE Flare
Timepoint [9] 0 0
Through week 24
Secondary outcome [10] 0 0
Time to Event_Rescue Therapy
Timepoint [10] 0 0
Through Week 24
Secondary outcome [11] 0 0
Proportion of Participants with Event-EoE Flare
Timepoint [11] 0 0
Through week 24
Secondary outcome [12] 0 0
Proportion of Participants with Event_Rescue Therapy
Timepoint [12] 0 0
Through week 24
Secondary outcome [13] 0 0
Incidence of Adverse Events (AEs)
Timepoint [13] 0 0
Through week 48
Secondary outcome [14] 0 0
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Timepoint [14] 0 0
Through week 48
Secondary outcome [15] 0 0
Pharmacokinetics- Ctrough
Timepoint [15] 0 0
Through week 24
Secondary outcome [16] 0 0
Change in DD Clinical Response
Timepoint [16] 0 0
At week 48
Secondary outcome [17] 0 0
Eosinophil Histologic Response (= 6/hpf)
Timepoint [17] 0 0
At week 48
Secondary outcome [18] 0 0
Eosinophil Histologic Response (< 15/hpf)
Timepoint [18] 0 0
At week 48
Secondary outcome [19] 0 0
Mean change in EREFS
Timepoint [19] 0 0
At week 48
Secondary outcome [20] 0 0
EoEHSS Grade Score
Timepoint [20] 0 0
At week 48
Secondary outcome [21] 0 0
EoEHSS Stage Score
Timepoint [21] 0 0
At week 48
Secondary outcome [22] 0 0
mDSD Composite Score
Timepoint [22] 0 0
At week 48
Secondary outcome [23] 0 0
Time to event_EoE Flare (Induction and Maintenance Phase)
Timepoint [23] 0 0
Through week 48
Secondary outcome [24] 0 0
Time to event_rescue therapy (Induction and Maintenance Phase)
Timepoint [24] 0 0
Through week 48
Secondary outcome [25] 0 0
Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase)
Timepoint [25] 0 0
Through week 48
Secondary outcome [26] 0 0
Proportion of participants with event rescue therapy (Induction and Maintenance Phases)
Timepoint [26] 0 0
Through week 48
Secondary outcome [27] 0 0
Pharmacokinetics-Ctrough
Timepoint [27] 0 0
Through week 48

Eligibility
Key inclusion criteria
Participants must satisfy the following criteria to be enrolled in the study:

1. Male or female patients aged = 12 and = 75 years, with a body weight of > 40 kg.
2. Histologic evidence of eosinophilic esophagitis, defined as a peak count of = 15 eosinophils/high-power field at 2 levels of the esophagus.

3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.

4. Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study.

5. Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study.

6. Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study.

7. Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of any of the following will exclude a participant from enrollment:

1. Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
2. Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance.
3. Evidence of a severe endoscopic structural abnormality in the esophagus.
4. Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study.
5. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.
6. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.
7. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.
8. Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study.
9. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.
10. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.
11. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.
12. 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. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis).
13. Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus.
14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.
15. Females who are pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/10/2024
Actual
Sample size
Target
Accrual to date
Final
430
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 548 - Concord
Recruitment hospital [2] 0 0
Local Institution - 554 - Liverpool
Recruitment hospital [3] 0 0
Local Institution - 540 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 546 - Maroorchydore
Recruitment hospital [5] 0 0
Local Institution - 550 - South Brisbane
Recruitment hospital [6] 0 0
Local Institution - 542 - Woolloongabba
Recruitment hospital [7] 0 0
Local Institution - 552 - Adelaide
Recruitment hospital [8] 0 0
Local Institution - 545 - Elizabeth Vale
Recruitment hospital [9] 0 0
Local Institution - 553 - Clayton
Recruitment hospital [10] 0 0
Local Institution - 543 - Footscray
Recruitment hospital [11] 0 0
Local Institution - 539 - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [13] 0 0
Local Institution - 538 - Fitzroy
Recruitment hospital [14] 0 0
Local Institution - 547 - Western Australia
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4558 - Maroorchydore
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
05112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3011 - Footscray
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
3065 - Fitzroy
Recruitment postcode(s) [14] 0 0
6056 - Western Australia
Recruitment outside Australia
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Warsaw
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Wroclaw
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Portugal
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04753697