Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

NCT04991935 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CC-93538-EE-0022020-004335-24
• Study Type: interventional
• Target: 368
• Locations: 14 countries
• Sites: 153

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  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.

  For a minimum of 28 months

Secondary Outcomes (1)

• Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies

  For a minimum of 28 months

Study Arms (1)

Administration of CC-93538

EXPERIMENTAL

Participants are administered CC-93538 dose subcutaneously once weekly

Drug: CC-93538

Interventions

CC-93538 DRUG

CC-93538

Also known as: BMS-986355, cendakimab

Administration of CC-93538

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously participated in prior clinical study CC-93538-EE-001 and either:
• 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
• Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (167)

Local Institution - 144

Birmingham, Alabama, 35211-1320, United States

Location

Local Institution - 082

Phoenix, Arizona, 85016, United States

Location

Local Institution - 147

Phoenix, Arizona, 85020-4348, United States

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Local Institution - 041

Scottsdale, Arizona, 85259, United States

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Local Institution - 029

Tucson, Arizona, 85715, United States

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Local Institution - 165

North Little Rock, Arkansas, 72117, United States

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Local Institution - 075

Lancaster, California, 93534, United States

Location

Local Institution - 047

Los Angeles, California, 90067, United States

Location

Local Institution - 160

San Diego, California, 92103-5639, United States

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Local Institution - 068

Aurora, Colorado, 80045, United States

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Local Institution - 067

Colorado Springs, Colorado, 80907, United States

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Local Institution - 128

Wheat Ridge, Colorado, 80033, United States

Location

Local Institution - 101

Bristol, Connecticut, 06010, United States

Location

Local Institution - 076

Farmington, Connecticut, 06030, United States

Location

Local Institution - 156

Hamden, Connecticut, 06518, United States

Location

Local Institution - 099

Clearwater, Florida, 33756-3839, United States

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Local Institution - 036

Inverness, Florida, 34452, United States

Location

Local Institution - 042

Jacksonville, Florida, 32256, United States

Location

Local Institution - 138

Miami, Florida, 33144-2035, United States

Location

Local Institution - 146

Orlando, Florida, 32806-1041, United States

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Local Institution - 169

Pinellas Park, Florida, 33781-3228, United States

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Local Institution - 168

Plantation, Florida, 33324-3345, United States

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Local Institution - 037

Port Orange, Florida, 32127, United States

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Local Institution - 171

Atlanta, Georgia, 30328, United States

Location

Local Institution - 054

Atlanta, Georgia, 30342, United States

Location

Local Institution - 117

Macon, Georgia, 31201, United States

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Local Institution - 024

Idaho Falls, Idaho, 83404, United States

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Local Institution - 039

Chicago, Illinois, 60611, United States

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Local Institution - 167

Gurnee, Illinois, 60031-5711, United States

Location

Local Institution - 127

Clive, Iowa, 50325, United States

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Local Institution - 094

Iowa City, Iowa, 52242, United States

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Local Institution - 035

Kansas City, Kansas, 66160, United States

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Local Institution - 046

Florence, Kentucky, 41042, United States

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Local Institution - 003

Baton Rouge, Louisiana, 70809, United States

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Local Institution - 020

Metairie, Louisiana, 70006, United States

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Local Institution - 044

Metairie, Louisiana, 70006, United States

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Local Institution - 164

Columbia, Maryland, 21045, United States

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Local Institution - 070

Glen Burnie, Maryland, 21061, United States

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Local Institution - 012

Hagerstown, Maryland, 21742, United States

Location

Local Institution - 053

Boston, Massachusetts, 02111, United States

Location

Local Institution - 083

South Dartmouth, Massachusetts, 02747, United States

Location

Local Institution - 009

Worcester, Massachusetts, 01655, United States

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Local Institution - 014

Wyoming, Michigan, 49519, United States

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Local Institution - 115

Plymouth, Minnesota, 55446, United States

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Local Institution - 049

Rochester, Minnesota, 55905, United States

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Local Institution - 007

Kansas City, Missouri, 64111, United States

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Local Institution - 032

St Louis, Missouri, 63110, United States

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Local Institution - 038

Omaha, Nebraska, 68198, United States

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Local Institution - 015

Lebanon, New Hampshire, 03756, United States

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Local Institution - 139

Albuquerque, New Mexico, 87106-4725, United States

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Local Institution - 028

Great Neck, New York, 11023, United States

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Local Institution - 051

New York, New York, 10016-4744, United States

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Local Institution - 116

Syracuse, New York, 13210-2306, United States

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Local Institution - 142

Syracuse, New York, 13210, United States

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Local Institution - 016

Chapel Hill, North Carolina, 27599, United States

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Local Institution - 106

Durham, North Carolina, 27705, United States

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Local Institution - 131

Greensboro, North Carolina, 27405, United States

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Local Institution - 130

Beavercreek, Ohio, 45440-3237, United States

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Local Institution - 006

Cincinnati, Ohio, 45219, United States

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Local Institution - 001

Cincinnati, Ohio, 45229, United States

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Local Institution - 052

Cincinnati, Ohio, 45267, United States

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Local Institution - 059

Columbus, Ohio, 43235, United States

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Local Institution - 166

Oklahoma City, Oklahoma, 73112-5550, United States

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Local Institution - 120

Hershey, Pennsylvania, 17033, United States

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Local Institution - 025

Philadelphia, Pennsylvania, 19104, United States

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Local Institution - 155

Pottsville, Pennsylvania, 17901-3636, United States

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Local Institution - 143

Anderson, South Carolina, 29621-2062, United States

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Local Institution - 057

Greenville, South Carolina, 29615, United States

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Local Institution - 114

Chattanooga, Tennessee, 37421, United States

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Local Institution - 095

Nashville, Tennessee, 37212, United States

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Local Institution - 105

Cedar Park, Texas, 78613, United States

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Local Institution - 148

Dallas, Texas, 75234-7858, United States

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Local Institution - 112

Houston, Texas, 77079-2211, United States

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Local Institution - 008

San Antonio, Texas, 78229, United States

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Local Institution - 077

Southlake, Texas, 76092, United States

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Local Institution - 104

Tyler, Texas, 75701, United States

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Local Institution - 125

Ogden, Utah, 84403-3323, United States

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Local Institution - 013

Lynchburg, Virginia, 24502, United States

Location

Local Institution - 064

Richmond, Virginia, 23249, United States

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Local Institution - 137

Spokane, Washington, 99218, United States

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Local Institution - 023

Vancouver, Washington, 98664, United States

Location

Local Institution - 695

Mar del Plata, B7600DHK, Argentina

Location

Local Institution - 696

Quilmes, B1878DVB, Argentina

Location

Local Institution - 548

Concord, New South Wales, 2139, Australia

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Local Institution - 554

Liverpool, New South Wales, 2170, Australia

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Local Institution - 540

Westmead, New South Wales, 2145, Australia

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Local Institution - 546

Maroorchydore, Queensland, 4558, Australia

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Local Institution - 550

South Brisbane, Queensland, 4101, Australia

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Local Institution - 542

Woolloongabba, Queensland, 4102, Australia

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Local Institution - 552

Adelaide, South Australia, 5000, Australia

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Local Institution - 545

Elizabeth Vale, South Australia, 05112, Australia

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Local Institution - 553

Clayton, Victoria, 3168, Australia

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Local Institution - 543

Footscray, Victoria, 3011, Australia

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Local Institution - 539

Melbourne, Victoria, 3004, Australia

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Local Institution - 549

Murdoch, Western Australia, 6150, Australia

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Local Institution - 538

Fitzroy, 3065, Australia

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Local Institution - 547

Western Australia, 6056, Australia

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Local Institution - 437

Burgenland, 7000, Austria

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Local Institution - 434

Graz, 8036, Austria

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Local Institution - 436

Linz, 4010, Austria

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Local Institution - 515

Brussels, 1090, Belgium

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Local Institution - 516

Kortrijk, 8500, Belgium

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Local Institution - 514

Leuven, 3000, Belgium

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Local Institution - 512

West-Vlaanderen, 8310, Belgium

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Local Institution - 201

Calgary, Alberta, T2N 2T9, Canada

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Local Institution - 208

Edmonton, Alberta, T5R 1W2, Canada

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Local Institution - 205

Edmonton, Alberta, T6K 4B2, Canada

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Local Institution - 203

Vancouver, British Columbia, V6Z 2K5, Canada

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Local Institution - 206

Victoria, British Columbia, V8V3M9, Canada

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Local Institution - 207

Ottawa, Ontario, K1H 1E4, Canada

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Local Institution - 200

Vaughan, Ontario, L4L 4Y7, Canada

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Local Institution - 330

Bayern, 82418, Germany

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Local Institution - 332

Brandenburg, 14770, Germany

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Local Institution - 339

Frankfurt am Main, 60313, Germany

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Local Institution - 338

Leipzig, 04129, Germany

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Local Institution - 337

München, 81675, Germany

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Local Institution - 278

Tel Aviv, Tel Aviv, 64239, Israel

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Local Institution - 281

Haifa, 3109601, Israel

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Local Institution - 283

Holon, 5822012, Israel

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Local Institution - 280

Jerusalem, 91031, Israel

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Local Institution - 282

Jerusalem, 91120, Israel

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Local Institution - 279

Ẕerifin, 70300, Israel

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Local Institution - 257

Genova, 16132, Italy

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Local Institution - 254

Milan, 20122, Italy

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Local Institution - 255

Padua, 35128, Italy

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Local Institution - 252

Pisa, 56100, Italy

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Local Institution - 253

Rome, 00161, Italy

Location

Local Institution - 600

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 595

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Local Institution - 599

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Local Institution - 593

Akita, 010-8543, Japan

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Local Institution - 606

Isehara City, Kanagawa, 259-1193, Japan

Location

Local Institution - 597

Kobe, 650-0017, Japan

Location

Local Institution - 598

Maebashi, 371-8511, Japan

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Local Institution - 607

Nagoya, 467-8602, Japan

Location

Local Institution - 603

Okayama, 700-8505, Japan

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Local Institution - 602

Shinjuku-Ku, 162-8655, Japan

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Local Institution - 605

Tokyo, 108-8329, Japan

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Local Institution - 590

Yamagata, 990-9585, Japan

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Local Institution - 385

Bydgoszcz, 85-079, Poland

Location

Local Institution - 389

Częstochowa, 42-202, Poland

Location

Local Institution - 390

Gdansk, 80-382, Poland

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Local Institution - 388

Katowice, 40-040, Poland

Location

Local Institution - 392

Lódz, 90-127, Poland

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Local Institution - 387

Warsaw, 00-189, Poland

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Local Institution - 393

Warsaw, 01-192, Poland

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Local Institution - 383

Warsaw, 04-501, Poland

Location

Local Institution - 391

Wroclaw, 50-088, Poland

Location

Local Institution - 384

Wroclaw, 51-162, Poland

Location

Local Institution - 307

Lisbon, 1169-045, Portugal

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Local Institution - 305

Lisbon, 1649-035, Portugal

Location

Local Institution - 306

Porto, 4099-001, Portugal

Location

Local Institution - 308

Porto, 4200-319, Portugal

Location

Local Institution - 408

Barcelona, 08036, Spain

Location

Local Institution - 410

Córdoba, 14001, Spain

Location

Local Institution - 409

Madrid, 28006, Spain

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Local Institution - 413

Madrid, 28046, Spain

Location

Local Institution - 411

Marbella, 29603, Spain

Location

Local Institution - 412

Seville, 41013, Spain

Location

Local Institution - 357

Lausanne, 1011, Switzerland

Location

Local Institution - 228

Belfast Northern Ireland, BT9 7AB, United Kingdom

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Local Institution - 231

Birmingham, B15 2SQ, United Kingdom

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Local Institution - 234

Cardiff, CF15 9SS, United Kingdom

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Local Institution - 235

Chorley, PR7 7NA, United Kingdom

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Local Institution - 233

Hexam, NE46 1QJ, United Kingdom

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Local Institution - 236

Liverpool, L22 0LG, United Kingdom

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Local Institution - 237

Manchester, M15 6SX, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastrointestinal Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Esophageal Diseases; Hypersensitivity

Interventions

cendakimab

Condition Hierarchy (Ancestors)

Digestive System Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: September 14, 2021
• Primary Completion: August 14, 2025
• Study Completion (Estimated): September 29, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

PT (4); US (81); PL (10); BE (4); AR (2); DE (5); AU (3); JP (12); ES (6); CH (1); IL (6); IT (5); GB (7); CA (7)