A Phase 3 interventional study of CC-93538 in Eosinophilic Esophagitis, sponsored by Celgene. Completed at 167 sites in 15 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
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.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's enrollment of 367 is above the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted after Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Previously participated in prior clinical study CC-93538-EE-001 and either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are administered CC-93538 dose subcutaneously once weekly
Drug: CC-93538
CC-93538
Also known as: BMS-986355, cendakimab
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.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
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.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
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.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
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.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
| Milestone | Administration of CC-93538 |
|---|---|
| Started | 367 |
| Completed | 6 |
| Not completed | 361 |
| Withdrew: Adverse event | 4 |
| Withdrew: Site closed by sponsor | 297 |
| Withdrew: Withdrawal by subject | 34 |
| Withdrew: Lost to follow-up | 11 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Physician decision | 5 |
| Withdrew: Other reasons | 5 |
| Withdrew: Non compliance with study drug | 1 |
| Withdrew: Pregnancy | 1 |
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.
| Participants | Administration of CC-93538 |
|---|---|
| Adverse Events (Mild) | 100 |
| Adverse Events (Moderate) | 167 |
| Adverse Events (Severe) | 31 |
| Any TEAEs | 298 |
| Any TESAEs | 25 |
| TEAEs related to CC-93538 | 72 |
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.
| Participants | Administration of CC-93538 |
|---|---|
| Eosinophil High to High | 34 |
| Alanine Amino Transferase Normal to High | 64 |
| Alanine Amino Transferase High to High | 26 |
| Aspartate Amino Transferase Normal to High | 45 |
| Aspartate Amino Transferase High to High | 10 |
| Gamma Glutamyl Transferase Normal to High | 21 |
| Gamma Glutamyl Transferase High to High | 19 |
SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.
| Participants | Administration of CC-93538 |
|---|---|
| Heart Rate > 100 AND CHANGE FROM BASELINE > 30 | 12 |
| Heart Rate < 55 AND CHANGE FROM BASELINE < -15 | 14 |
| SBP > 140 AND CHANGE FROM BASELINE > 20 | 51 |
| SBP < 90 AND CHANGE FROM BASELINE < -20 | 0 |
| DBP > 90 AND CHANGE FROM BASELINE > 10 | 73 |
| DBP < 55 AND CHANGE FROM BASELINE < -10 | 13 |
| Physical Examination | 0 |
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.
| Participants | Administration of CC-93538 |
|---|---|
| Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies | 48 |
Collected over All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CC-93538 360 mg QW | 0/367 (0%) | 25/367 (6.8%) | 158/367 (43.1%) |
| Event | CC-93538 360 mg QW |
|---|---|
| Anaphylactic reactionImmune system disorders | 5/367 |
| Eosinophilic oesophagitisGastrointestinal disorders | 2/367 |
| Atrial fibrillationCardiac disorders | 1/367 |
| Abdominal painGastrointestinal disorders | 1/367 |
| Oesophageal ruptureGastrointestinal disorders | 1/367 |
| PancreatitisGastrointestinal disorders | 1/367 |
| VomitingGastrointestinal disorders | 1/367 |
| Cholecystitis acuteHepatobiliary disorders | 1/367 |
| Gastrointestinal procedural complicationInjury, poisoning and procedural complications | 1/367 |
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 1/367 |
| Event | CC-93538 360 mg QW |
|---|---|
| COVID-19Infections and infestations | 47/367 |
| Injection site reactionGeneral disorders | 40/367 |
| Upper respiratory tract infectionInfections and infestations | 40/367 |
| NasopharyngitisInfections and infestations | 36/367 |
| InfluenzaInfections and infestations | 24/367 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 24/367 |
| HeadacheNervous system disorders | 19/367 |
| Age, Continuous(years) | Administration of CC-93538 |
|---|---|
| Mean | 36.1 ± 11.65 |
| Sex: Female, Male(Participants) | Administration of CC-93538 |
|---|---|
| Female | 104 |
| Male | 263 |
| Ethnicity (NIH/OMB)(Participants) | Administration of CC-93538 |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 355 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Administration of CC-93538 |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 24 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 3 |
| White | 337 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
Showing the first 100 of 167 sites across 15 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Ran from Aug 2022 to primary completion in Aug 2025, 36 months.
Results were first posted in Apr 2026, 7 months after primary completion.
Of 16 phase 3 interventional studies under Eosinophilic Esophagitis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 37. This study's 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cendakimab