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Eosinophilic EsophagitisPhase 3NCT04991935

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

A Phase 3 study testing CC-93538 in people with Eosinophilic Esophagitis, run by Celgene at 167 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
CC-93538
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
167 sitesin 15 countries
Study dates
9 Aug 2022to 14 Aug 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

167 sites in 15 countries.

167 sites in 15 countries

United States81 sites

  • Local Institution - 139

    Albuquerque, New Mexico, 87106-4725

  • Local Institution - 143

    Anderson, South Carolina, 29621-2062

  • Local Institution - 171

    Atlanta, Georgia, 30328

  • Local Institution - 054

    Atlanta, Georgia, 30342

  • Local Institution - 068

    Aurora, Colorado, 80045

  • Local Institution - 003

    Baton Rouge, Louisiana, 70809

  • Local Institution - 130

    Beavercreek, Ohio, 45440-3237

  • Local Institution - 144

    Birmingham, Alabama, 35211-1320

  • Local Institution - 053

    Boston, Massachusetts, 02111

  • Local Institution - 101

    Bristol, Connecticut, 06010

  • Local Institution - 105

    Cedar Park, Texas, 78613

  • Local Institution - 016

    Chapel Hill, North Carolina, 27599

  • Local Institution - 114

    Chattanooga, Tennessee, 37421

  • Local Institution - 039

    Chicago, Illinois, 60611

  • Local Institution - 006

    Cincinnati, Ohio, 45219

  • Local Institution - 001

    Cincinnati, Ohio, 45229

  • Local Institution - 052

    Cincinnati, Ohio, 45267

  • Local Institution - 099

    Clearwater, Florida, 33756-3839

  • Local Institution - 127

    Clive, Iowa, 50325

  • Local Institution - 067

    Colorado Springs, Colorado, 80907

  • Local Institution - 164

    Columbia, Maryland, 21045

  • Local Institution - 059

    Columbus, Ohio, 43235

  • Local Institution - 148

    Dallas, Texas, 75234-7858

  • Local Institution - 106

    Durham, North Carolina, 27705

  • Local Institution - 076

    Farmington, Connecticut, 06030

  • Local Institution - 046

    Florence, Kentucky, 41042

  • Local Institution - 070

    Glen Burnie, Maryland, 21061

  • Local Institution - 028

    Great Neck, New York, 11023

  • Local Institution - 131

    Greensboro, North Carolina, 27405

  • Local Institution - 057

    Greenville, South Carolina, 29615

  • Local Institution - 167

    Gurnee, Illinois, 60031-5711

  • Local Institution - 012

    Hagerstown, Maryland, 21742

  • Local Institution - 156

    Hamden, Connecticut, 06518

  • Local Institution - 120

    Hershey, Pennsylvania, 17033

  • Local Institution - 112

    Houston, Texas, 77079-2211

  • Local Institution - 024

    Idaho Falls, Idaho, 83404

  • Local Institution - 036

    Inverness, Florida, 34452

  • Local Institution - 094

    Iowa City, Iowa, 52242

  • Local Institution - 042

    Jacksonville, Florida, 32256

  • Local Institution - 035

    Kansas City, Kansas, 66160

  • Local Institution - 007

    Kansas City, Missouri, 64111

  • Local Institution - 075

    Lancaster, California, 93534

  • Local Institution - 015

    Lebanon, New Hampshire, 03756

  • Local Institution - 047

    Los Angeles, California, 90067

  • Local Institution - 013

    Lynchburg, Virginia, 24502

  • Local Institution - 117

    Macon, Georgia, 31201

  • Local Institution - 020

    Metairie, Louisiana, 70006

  • Local Institution - 044

    Metairie, Louisiana, 70006

  • Local Institution - 138

    Miami, Florida, 33144-2035

  • Local Institution - 095

    Nashville, Tennessee, 37212

  • Local Institution - 051

    New York, New York, 10016-4744

  • Local Institution - 165

    North Little Rock, Arkansas, 72117

  • Local Institution - 125

    Ogden, Utah, 84403-3323

  • Local Institution - 166

    Oklahoma City, Oklahoma, 73112-5550

  • Local Institution - 038

    Omaha, Nebraska, 68198

  • Local Institution - 146

    Orlando, Florida, 32806-1041

  • Local Institution - 025

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 082

    Phoenix, Arizona, 85016

  • Local Institution - 147

    Phoenix, Arizona, 85020-4348

  • Local Institution - 169

    Pinellas Park, Florida, 33781-3228

  • Local Institution - 168

    Plantation, Florida, 33324-3345

  • Local Institution - 115

    Plymouth, Minnesota, 55446

  • Local Institution - 037

    Port Orange, Florida, 32127

  • Local Institution - 155

    Pottsville, Pennsylvania, 17901-3636

  • Local Institution - 064

    Richmond, Virginia, 23249

  • Local Institution - 049

    Rochester, Minnesota, 55905

  • Local Institution - 008

    San Antonio, Texas, 78229

  • Local Institution - 160

    San Diego, California, 92103-5639

  • Local Institution - 041

    Scottsdale, Arizona, 85259

  • Local Institution - 083

    South Dartmouth, Massachusetts, 02747

  • Local Institution - 077

    Southlake, Texas, 76092

  • Local Institution - 137

    Spokane, Washington, 99218

  • Local Institution - 032

    St Louis, Missouri, 63110

  • Local Institution - 116

    Syracuse, New York, 13210-2306

  • Local Institution - 142

    Syracuse, New York, 13210

  • Local Institution - 029

    Tucson, Arizona, 85715

  • Local Institution - 104

    Tyler, Texas, 75701

  • Local Institution - 023

    Vancouver, Washington, 98664

  • Local Institution - 128

    Wheat Ridge, Colorado, 80033

  • Local Institution - 009

    Worcester, Massachusetts, 01655

  • Local Institution - 014

    Wyoming, Michigan, 49519

Other trials in United States

Australia14 sites

  • Local Institution - 552

    Adelaide, South Australia, 5000

  • Local Institution - 553

    Clayton, Victoria, 3168

  • Local Institution - 548

    Concord, New South Wales, 2139

  • Local Institution - 545

    Elizabeth Vale, South Australia, 05112

  • Local Institution - 538

    Fitzroy, 3065

  • Local Institution - 543

    Footscray, Victoria, 3011

  • Local Institution - 554

    Liverpool, New South Wales, 2170

  • Local Institution - 546

    Maroorchydore, Queensland, 4558

  • Local Institution - 539

    Melbourne, Victoria, 3004

  • Local Institution - 549

    Murdoch, Western Australia, 6150

  • Local Institution - 550

    South Brisbane, Queensland, 4101

  • Local Institution - 547

    Western Australia, 6056

  • Local Institution - 540

    Westmead, New South Wales, 2145

  • Local Institution - 542

    Woolloongabba, Queensland, 4102

Other trials in Australia

Japan12 sites

  • Local Institution - 593

    Akita, 010-8543

  • Local Institution - 595

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 606

    Isehara City, Kanagawa, 259-1193

  • Local Institution - 597

    Kobe, 650-0017

  • Local Institution - 598

    Maebashi, 371-8511

  • Local Institution - 607

    Nagoya, 467-8602

  • Local Institution - 600

    Nishinomiya, Hyōgo, 663-8501

  • Local Institution - 603

    Okayama, 700-8505

  • Local Institution - 599

    Setagaya-ku, Tokyo, 157-8535

  • Local Institution - 602

    Shinjuku-Ku, 162-8655

  • Local Institution - 605

    Tokyo, 108-8329

  • Local Institution - 590

    Yamagata, 990-9585

Other trials in Japan

Poland10 sites

  • Local Institution - 385

    Bydgoszcz, 85-079

  • Local Institution - 389

    Częstochowa, 42-202

  • Local Institution - 390

    Gdansk, 80-382

  • Local Institution - 388

    Katowice, 40-040

  • Local Institution - 392

    Lódz, 90-127

  • Local Institution - 387

    Warsaw, 00-189

  • Local Institution - 393

    Warsaw, 01-192

  • Local Institution - 383

    Warsaw, 04-501

  • Local Institution - 391

    Wroclaw, 50-088

  • Local Institution - 384

    Wroclaw, 51-162

Other trials in Poland

Canada7 sites

  • Local Institution - 201

    Calgary, Alberta, T2N 2T9

  • Local Institution - 208

    Edmonton, Alberta, T5R 1W2

  • Local Institution - 205

    Edmonton, Alberta, T6K 4B2

  • Local Institution - 207

    Ottawa, Ontario, K1H 1E4

  • Local Institution - 203

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution - 200

    Vaughan, Ontario, L4L 4Y7

  • Local Institution - 206

    Victoria, British Columbia, V8V3M9

Other trials in Canada

United Kingdom7 sites

  • Local Institution - 228

    Belfast Northern Ireland, BT9 7AB

  • Local Institution - 231

    Birmingham, B15 2SQ

  • Local Institution - 234

    Cardiff, CF15 9SS

  • Local Institution - 235

    Chorley, PR7 7NA

  • Local Institution - 233

    Hexam, NE46 1QJ

  • Local Institution - 236

    Liverpool, L22 0LG

  • Local Institution - 237

    Manchester, M15 6SX

Other trials in United Kingdom

Israel6 sites

  • Local Institution - 281

    Haifa, 3109601

  • Local Institution - 283

    Holon, 5822012

  • Local Institution - 280

    Jerusalem, 91031

  • Local Institution - 282

    Jerusalem, 91120

  • Local Institution - 278

    Tel Aviv, Tel Aviv, 64239

  • Local Institution - 279

    Ẕerifin, 70300

Other trials in Israel

Spain6 sites

  • Local Institution - 408

    Barcelona, 08036

  • Local Institution - 410

    Córdoba, 14001

  • Local Institution - 409

    Madrid, 28006

  • Local Institution - 413

    Madrid, 28046

  • Local Institution - 411

    Marbella, 29603

  • Local Institution - 412

    Seville, 41013

Other trials in Spain

Germany5 sites

  • Local Institution - 330

    Bayern, 82418

  • Local Institution - 332

    Brandenburg an der Havel, 14770

  • Local Institution - 339

    Frankfurt am Main, 60313

  • Local Institution - 338

    Leipzig, 04129

  • Local Institution - 337

    München, 81675

Other trials in Germany

Italy5 sites

  • Local Institution - 257

    Genova, 16132

  • Local Institution - 254

    Milan, 20122

  • Local Institution - 255

    Padova, 35128

  • Local Institution - 252

    Pisa, 56100

  • Local Institution - 253

    Rome, 00161

Other trials in Italy

Belgium4 sites

  • Local Institution - 515

    Brussels, 1090

  • Local Institution - 516

    Kortrijk, 8500

  • Local Institution - 514

    Leuven, 3000

  • Local Institution - 512

    West-Vlaanderen, 8310

Other trials in Belgium

Portugal4 sites

  • Local Institution - 307

    Lisbon, 1169-045

  • Local Institution - 305

    Lisbon, 1649-035

  • Local Institution - 306

    Porto, 4099-001

  • Local Institution - 308

    Porto, 4200-319

Other trials in Portugal

Austria3 sites

  • Local Institution - 437

    Burgenland, 7000

  • Local Institution - 434

    Graz, 8036

  • Local Institution - 436

    Linz, 4010

Other trials in Austria

Argentina2 sites

  • Local Institution - 695

    Mar del Plata, B7600DHK

  • Local Institution - 696

    Quilmes, B1878DVB

Other trials in Argentina

Switzerland1 site

  • Local Institution - 357

    Lausanne, 1011

Other trials in Switzerland

About this study

Official 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

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.

Being tested
CC-93538
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
Medical subject headings
Eosinophilic Esophagitis, Gastrointestinal Diseases, Esophagitis, Gastroenteritis, Eosinophilia, Esophageal Diseases, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-93538Drug

    Also called BMS-986355, cendakimab

    CC-93538

Study groups in NCT04991935
Study groupRoleWhat they receive
Administration of CC-93538ExperimentalParticipants are administered CC-93538 dose subcutaneously once weekly
Receives: Drug: CC-93538

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

    Measured: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

  2. Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters

    Blood samples were collected to assess clinical significant shifts in laboratory parameters. "Normal to High" means at baseline the value is Normal and maximum post baseline value is High.

    Measured: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

  3. Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters

    SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.

    Measured: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Secondary outcomes (1)

  1. Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies

    Blood samples were collected to assess Anti-CEN antibodies. Post-Baseline ADA Positive define as 1) at least 1 positive post-baseline given baseline is negative or missing; or 2) at least 1 positive post-baseline with titer >= 4-fold baseline titer given positive baseline.

    Measured: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start9 Aug 2022
  3. Primary completion14 Aug 2025
  4. Study completion14 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991935
Sponsor's protocol ID
CC-93538-EE-002
Other IDs
2020-004335-24
Status last verified
Mar 2026
First submitted
28 Jul 2021
Last updated
6 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

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