Clinical trial NCT04753697: A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Official title: A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2021-02-15
Enrollment: 430
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.

Participants will be randomized at the beginning of the study into 3 treatment arms:

* Placebo for Induction and Maintenance
* CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
* CC-93538 360 mg SC once weekly for Induction and Maintenance


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change From Baseline in Mean Dysphagia Days (DD) at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48
timeFrame: Week 48
measure: Change From Baseline in Mean Dysphagia Days (DD) at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24
timeFrame: Baseline (Day 1) , Week 24
measure: Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48
timeFrame: Baseline (Day 1) , Week 48
measure: Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24
timeFrame: Baseline (Day 1), Week 24
measure: Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48
timeFrame: Baseline (Day 1) , Week 48
measure: Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24
timeFrame: Baseline (Day 1), Week 24
measure: Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48
timeFrame: Baseline (Day 1) , Week 48
measure: Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24
timeFrame: Baseline (11 days prior to Day 1) and Week 24
measure: Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48
timeFrame: Baseline (Day 1) , Week 48
measure: Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24
timeFrame: Baseline (11 days prior to Day 1) and Week 24
measure: Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48
timeFrame: Baseline (11 days prior to Day 1) and Week 48
measure: Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
timeFrame: Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
timeFrame: Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Time to First Event of Eosinophilic Esophagitis (EoE) Flare
timeFrame: From first dose (Day 1) and Up to Week 48
measure: Time to First Use of Rescue Medication
timeFrame: From first dose (Day 1) and Up to Week 48
measure: Percentage of Participants With Any Events of Use of Rescue Medication
timeFrame: From first dose (Day 1) and up to Week 48
measure: Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare
timeFrame: From first dose (Day 1) and up to Week 48
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose (Day 1) till up to Week 48
measure: Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
timeFrame: From first dose (Day 1) till up to Week 48
measure: Number of Participants With Post-Baseline Vital Sign Abnormalities
timeFrame: From first dose (Day 1) till up to Week 48
measure: Change From Baseline in Physical Parameters - Height at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Physical Parameters - Height at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Change From Baseline in Physical Parameters - Weight at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Physical Parameters - Weight at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Change From Baseline in Physical Parameters - Body Mass Index at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Physical Parameters - Body Mass Index at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Number of Participants With Anti-Drug Antibodies (ADA)
timeFrame: Pre-dose Week 24 and Pre-dose Week 48
measure: Serum Trough Concentration of CC-93538 at Week 24 and Week 48
timeFrame: Pre-dose Week 24 and Pre-dose Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 144
state: Alabama
city: Tuscaloosa
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state: Alabama
city: Phoenix
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state: Arizona
city: Phoenix
country: United States
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state: Arizona
city: Scottsdale
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state: Arizona
city: Tucson
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state: Arizona
city: North Little Rock
country: United States
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state: Arkansas
city: Lancaster
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state: California
city: Los Angeles
country: United States
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state: California
city: Oakland
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state: California
city: San Diego
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state: California
city: Aurora
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state: Colorado
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
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state: Colorado
city: Littleton
country: United States
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state: Colorado
city: Wheat Ridge
country: United States
facility: Local Institution - 128
state: Colorado
city: Bristol
country: United States
facility: Local Institution - 101
state: Connecticut
city: Farmington
country: United States
facility: Local Institution - 076
state: Connecticut
city: Hamden
country: United States
facility: Local Institution - 156
state: Connecticut
city: Clearwater
country: United States
facility: Local Institution - 099
state: Florida
city: Inverness
country: United States
facility: Local Institution - 036
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 042
state: Florida
city: Miami
country: United States
facility: Local Institution - 161
state: Florida
city: Miami
country: United States
facility: Local Institution - 138
state: Florida
city: North Miami Beach
country: United States
facility: Local Institution - 110
state: Florida
city: Orlando
country: United States
facility: Local Institution - 146
state: Florida
city: Orlando
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Pinellas Park
country: United States
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state: Florida
city: Plantation
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Sweetwater
country: United States
facility: Local Institution - 140
state: Florida
city: Atlanta
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state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 171
state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Macon
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state: Georgia
city: Idaho Falls
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state: Idaho
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state: Illinois
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state: Illinois
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state: Indiana
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state: Iowa
city: Iowa City
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state: Iowa
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state: Kansas
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state: Kentucky
city: Louisville
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state: Kentucky
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state: Louisiana
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state: Louisiana
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state: Louisiana
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state: Maryland
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state: Maryland
city: Columbia
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state: Maryland
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state: Maryland
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state: Maryland
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state: Massachusetts
city: Boston
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state: Massachusetts
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state: Massachusetts
city: South Dartmouth
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state: Massachusetts
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state: Michigan
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state: Michigan
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state: Minnesota
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state: Minnesota
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state: Mississippi
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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: North Carolina
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state: North Carolina
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state: North Carolina
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state: North Carolina
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state: Ohio
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state: Ohio
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state: Ohio
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state: Ohio
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state: Ohio
city: Columbus
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state: Ohio
city: Columbus
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Hershey
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pottsville
country: United States
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state: Pennsylvania
city: Providence
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state: Rhode Island
city: Anderson
country: United States
facility: Local Institution - 143
state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Nashville
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state: Tennessee
city: Cedar Park
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Rockwell
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state: Texas
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state: Texas
city: Southlake
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state: Texas
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country: United States
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state: Texas
city: Draper
country: United States
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state: Utah
city: Ogden
country: United States
facility: Local Institution - 125
state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: Leesburg
country: United States
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state: Virginia
city: Lynchburg
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Roanoke
country: United States
facility: Local Institution - 134
state: Virginia
city: Spokane
country: United States
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state: Washington
city: Vancouver
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state: Washington
city: Milwaukee
country: United States
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state: Wisconsin
city: Milwaukee
country: United States
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state: Wisconsin
city: Casper
country: United States
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state: Wyoming
city: Buenos Aires
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Quilmes
country: Argentina
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state: New South Wales
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state: New South Wales
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state: New South Wales
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state: Queensland
city: South Brisbane
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state: Queensland
city: Woolloongabba
country: Australia
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state: Queensland
city: Adelaide
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state: South Australia
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state: South Australia
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state: Victoria
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state: Victoria
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state: Victoria
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state: Western Australia
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city: Burgenland
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state: Alberta
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state: Alberta
city: Edmonton
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state: Alberta
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state: British Columbia
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state: British Columbia
city: Ottawa
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state: Ontario
city: Vaughan
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state: Ontario
city: Bayern
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city: Brandenburg an der Havel
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city: Frankfurt am Main
country: Germany
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city: Hamburg
country: Germany
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city: Leipzig
country: Germany
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city: Leipzig
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country: Italy
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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
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country: Japan
facility: Local Institution - 597
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country: Japan
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city: Nagoya
country: Japan
facility: Local Institution - 604
city: Nagoya
country: Japan
facility: Local Institution - 607
city: Niigata-shi
country: Japan
facility: Local Institution - 592
city: Okayama-Shi
country: Japan
facility: Local Institution - 603
city: Osaka
country: Japan
facility: Local Institution - 591
city: Shibukawa
country: Japan
facility: Local Institution - 601
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 602
city: Tokyo
country: Japan
facility: Local Institution - 605
city: Toyoake
country: Japan
facility: Local Institution - 596
city: Yamagata
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 - 386
city: Wroclaw
country: Poland
facility: Local Institution - 384
city: Wrocław
country: Poland
facility: Local Institution - 391
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
city: Southampton
country: United Kingdom
facility: Local Institution - 226
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: