New drug shows promise for Long-Term control of esophagus inflammation

NCT ID NCT04991935

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of a drug called CC-93538 (cendakimab) for people with eosinophilic esophagitis, a condition that causes inflammation in the esophagus. It enrolled 367 adults and teens who had already taken part in earlier studies of the same drug. The main goal is to track side effects and other safety measures over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CC-93538 (cendakimab)
What this could lead to: If successful, this could show that CC-93538 is safe for long-term use, potentially offering a new treatment option for eosinophilic esophagitis.
What could go wrong: This is an open-label extension study without a placebo group, so results may be less reliable. Long-term safety data is still being collected, and the drug may not prove effective or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

367 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

allergic disease digestive system disorder Eosinophilia eosinophilic esophagitis esophageal disorder esophagitis gastroenteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

Contacts and locations

Locations

Local Institution - 001

Cincinnati, Ohio, 45229, United States
Local Institution - 003

Baton Rouge, Louisiana, 70809, United States
Local Institution - 006

Cincinnati, Ohio, 45219, United States
Local Institution - 007

Kansas City, Missouri, 64111, United States
Local Institution - 008

San Antonio, Texas, 78229, United States
Local Institution - 009

Worcester, Massachusetts, 01655, United States
Local Institution - 012

Hagerstown, Maryland, 21742, United States
Local Institution - 013

Lynchburg, Virginia, 24502, United States
Local Institution - 014

Wyoming, Michigan, 49519, United States
Local Institution - 015

Lebanon, New Hampshire, 03756, United States
Local Institution - 016

Chapel Hill, North Carolina, 27599, United States
Local Institution - 020

Metairie, Louisiana, 70006, United States
Local Institution - 023

Vancouver, Washington, 98664, United States
Local Institution - 024

Idaho Falls, Idaho, 83404, United States
Local Institution - 025

Philadelphia, Pennsylvania, 19104, United States
Local Institution - 028

Great Neck, New York, 11023, United States
Local Institution - 029

Tucson, Arizona, 85715, United States
Local Institution - 032

St Louis, Missouri, 63110, United States
Local Institution - 035

Kansas City, Kansas, 66160, United States
Local Institution - 036

Inverness, Florida, 34452, United States
Local Institution - 037

Port Orange, Florida, 32127, United States
Local Institution - 038

Omaha, Nebraska, 68198, United States
Local Institution - 039

Chicago, Illinois, 60611, United States
Local Institution - 041

Scottsdale, Arizona, 85259, United States
Local Institution - 042

Jacksonville, Florida, 32256, United States
Local Institution - 044

Metairie, Louisiana, 70006, United States
Local Institution - 046

Florence, Kentucky, 41042, United States
Local Institution - 047

Los Angeles, California, 90067, United States
Local Institution - 049

Rochester, Minnesota, 55905, United States
Local Institution - 051

New York, New York, 10016-4744, United States
Local Institution - 052

Cincinnati, Ohio, 45267, United States
Local Institution - 053

Boston, Massachusetts, 02111, United States
Local Institution - 054

Atlanta, Georgia, 30342, United States
Local Institution - 057

Greenville, South Carolina, 29615, United States
Local Institution - 059

Columbus, Ohio, 43235, United States
Local Institution - 064

Richmond, Virginia, 23249, United States
Local Institution - 067

Colorado Springs, Colorado, 80907, United States
Local Institution - 068

Aurora, Colorado, 80045, United States
Local Institution - 070

Glen Burnie, Maryland, 21061, United States
Local Institution - 075

Lancaster, California, 93534, United States
Local Institution - 076

Farmington, Connecticut, 06030, United States
Local Institution - 077

Southlake, Texas, 76092, United States
Local Institution - 082

Phoenix, Arizona, 85016, United States
Local Institution - 083

South Dartmouth, Massachusetts, 02747, United States
Local Institution - 094

Iowa City, Iowa, 52242, United States
Local Institution - 095

Nashville, Tennessee, 37212, United States
Local Institution - 099

Clearwater, Florida, 33756-3839, United States
Local Institution - 101

Bristol, Connecticut, 06010, United States
Local Institution - 104

Tyler, Texas, 75701, United States
Local Institution - 105

Cedar Park, Texas, 78613, United States
Local Institution - 106

Durham, North Carolina, 27705, United States
Local Institution - 112

Houston, Texas, 77079-2211, United States
Local Institution - 114

Chattanooga, Tennessee, 37421, United States
Local Institution - 115

Plymouth, Minnesota, 55446, United States
Local Institution - 116

Syracuse, New York, 13210-2306, United States
Local Institution - 117

Macon, Georgia, 31201, United States
Local Institution - 120

Hershey, Pennsylvania, 17033, United States
Local Institution - 125

Ogden, Utah, 84403-3323, United States
Local Institution - 127

Clive, Iowa, 50325, United States
Local Institution - 128

Wheat Ridge, Colorado, 80033, United States
Local Institution - 130

Beavercreek, Ohio, 45440-3237, United States
Local Institution - 131

Greensboro, North Carolina, 27405, United States
Local Institution - 137

Spokane, Washington, 99218, United States
Local Institution - 138

Miami, Florida, 33144-2035, United States
Local Institution - 139

Albuquerque, New Mexico, 87106-4725, United States
Local Institution - 142

Syracuse, New York, 13210, United States
Local Institution - 143

Anderson, South Carolina, 29621-2062, United States
Local Institution - 144

Birmingham, Alabama, 35211-1320, United States
Local Institution - 146

Orlando, Florida, 32806-1041, United States
Local Institution - 147

Phoenix, Arizona, 85020-4348, United States
Local Institution - 148

Dallas, Texas, 75234-7858, United States
Local Institution - 155

Pottsville, Pennsylvania, 17901-3636, United States
Local Institution - 156

Hamden, Connecticut, 06518, United States
Local Institution - 160

San Diego, California, 92103-5639, United States
Local Institution - 164

Columbia, Maryland, 21045, United States
Local Institution - 165

North Little Rock, Arkansas, 72117, United States
Local Institution - 166

Oklahoma City, Oklahoma, 73112-5550, United States
Local Institution - 167

Gurnee, Illinois, 60031-5711, United States
Local Institution - 168

Plantation, Florida, 33324-3345, United States
Local Institution - 169

Pinellas Park, Florida, 33781-3228, United States
Local Institution - 171

Atlanta, Georgia, 30328, United States
Local Institution - 200

Vaughan, Ontario, L4L 4Y7, Canada
Local Institution - 201

Calgary, Alberta, T2N 2T9, Canada
Local Institution - 203

Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution - 205

Edmonton, Alberta, T6K 4B2, Canada
Local Institution - 206

Victoria, British Columbia, V8V3M9, Canada
Local Institution - 207

Ottawa, Ontario, K1H 1E4, Canada
Local Institution - 208

Edmonton, Alberta, T5R 1W2, Canada
Local Institution - 228

Belfast Northern Ireland, BT9 7AB, United Kingdom
Local Institution - 231

Birmingham, B15 2SQ, United Kingdom
Local Institution - 233

Hexam, NE46 1QJ, United Kingdom
Local Institution - 234

Cardiff, CF15 9SS, United Kingdom
Local Institution - 235

Chorley, PR7 7NA, United Kingdom
Local Institution - 236

Liverpool, L22 0LG, United Kingdom
Local Institution - 237

Manchester, M15 6SX, United Kingdom
Local Institution - 252

Pisa, 56100, Italy
Local Institution - 253

Rome, 00161, Italy
Local Institution - 254

Milan, 20122, Italy
Local Institution - 255

Padova, 35128, Italy
Local Institution - 257

Genova, 16132, Italy
Local Institution - 278

Tel Aviv, Tel Aviv, 64239, Israel
Local Institution - 279

Ẕerifin, 70300, Israel
Local Institution - 280

Jerusalem, 91031, Israel
Local Institution - 281

Haifa, 3109601, Israel
Local Institution - 282

Jerusalem, 91120, Israel
Local Institution - 283

Holon, 5822012, Israel
Local Institution - 305

Lisbon, 1649-035, Portugal
Local Institution - 306

Porto, 4099-001, Portugal
Local Institution - 307

Lisbon, 1169-045, Portugal
Local Institution - 308

Porto, 4200-319, Portugal
Local Institution - 330

Bayern, 82418, Germany
Local Institution - 332

Brandenburg an der Havel, 14770, Germany
Local Institution - 337

München, 81675, Germany
Local Institution - 338

Leipzig, 04129, Germany
Local Institution - 339

Frankfurt am Main, 60313, Germany
Local Institution - 357

Lausanne, 1011, Switzerland
Local Institution - 383

Warsaw, 04-501, Poland
Local Institution - 384

Wroclaw, 51-162, Poland
Local Institution - 385

Bydgoszcz, 85-079, Poland
Local Institution - 387

Warsaw, 00-189, Poland
Local Institution - 388

Katowice, 40-040, Poland
Local Institution - 389

Częstochowa, 42-202, Poland
Local Institution - 390

Gdansk, 80-382, Poland
Local Institution - 391

Wroclaw, 50-088, Poland
Local Institution - 392

Lódz, 90-127, Poland
Local Institution - 393

Warsaw, 01-192, Poland
Local Institution - 408

Barcelona, 08036, Spain
Local Institution - 409

Madrid, 28006, Spain
Local Institution - 410

Córdoba, 14001, Spain
Local Institution - 411

Marbella, 29603, Spain
Local Institution - 412

Seville, 41013, Spain
Local Institution - 413

Madrid, 28046, Spain
Local Institution - 434

Graz, 8036, Austria
Local Institution - 436

Linz, 4010, Austria
Local Institution - 437

Burgenland, 7000, Austria
Local Institution - 512

West-Vlaanderen, 8310, Belgium
Local Institution - 514

Leuven, 3000, Belgium
Local Institution - 515

Brussels, 1090, Belgium
Local Institution - 516

Kortrijk, 8500, Belgium
Local Institution - 538

Fitzroy, 3065, Australia
Local Institution - 539

Melbourne, Victoria, 3004, Australia
Local Institution - 540

Westmead, New South Wales, 2145, Australia
Local Institution - 542

Woolloongabba, Queensland, 4102, Australia
Local Institution - 543

Footscray, Victoria, 3011, Australia
Local Institution - 545

Elizabeth Vale, South Australia, 05112, Australia
Local Institution - 546

Maroorchydore, Queensland, 4558, Australia
Local Institution - 547

Western Australia, 6056, Australia
Local Institution - 548

Concord, New South Wales, 2139, Australia
Local Institution - 549

Murdoch, Western Australia, 6150, Australia
Local Institution - 550

South Brisbane, Queensland, 4101, Australia
Local Institution - 552

Adelaide, South Australia, 5000, Australia
Local Institution - 553

Clayton, Victoria, 3168, Australia
Local Institution - 554

Liverpool, New South Wales, 2170, Australia
Local Institution - 590

Yamagata, 990-9585, Japan
Local Institution - 593

Akita, 010-8543, Japan
Local Institution - 595

Bunkyo-ku, Tokyo, 113-8603, Japan
Local Institution - 597

Kobe, 650-0017, Japan
Local Institution - 598

Maebashi, 371-8511, Japan
Local Institution - 599

Setagaya-ku, Tokyo, 157-8535, Japan
Local Institution - 600

Nishinomiya, Hyōgo, 663-8501, Japan
Local Institution - 602

Shinjuku-Ku, 162-8655, Japan
Local Institution - 603

Okayama, 700-8505, Japan
Local Institution - 605

Tokyo, 108-8329, Japan
Local Institution - 606

Isehara City, Kanagawa, 259-1193, Japan
Local Institution - 607

Nagoya, 467-8602, Japan
Local Institution - 695

Mar del Plata, B7600DHK, Argentina
Local Institution - 696

Quilmes, B1878DVB, Argentina

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