Safety Study of CC-93538 in Adult and Adolescent Particip... | NCT04991935

ID	Type	Description	Link
2020-004335-24	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Administration of CC-93538	Experimental	Participants are administered CC-93538 dose subcutaneously once weekly	Drug: CC-93538

Name	Type	Description	Arm Group Labels	Other Names
CC-93538	Drug	CC-93538	Administration of CC-93538	BMS-986355

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Secondary Outcomes

Measure	Description	Time Frame
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.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 144		Birmingham	Alabama	35211-1320	United States
Local Institution - 082

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Administration of CC-93538	Participants were administered CC-93538 360 mg subcutaneously once weekly

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 30, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Open label extension population included all the enrolled participants.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Administration of CC-93538	Participants were administered CC-93538 360 mg subcutaneously once weekly

Units	Counts
Participants	OG000367

Title

Denominators

Categories

Adverse Events (Mild)

Title	Measurements
	OG000100

Adverse Events (Moderate)

Title	Measurements
	OG000167

Adverse Events (Severe)

Primary

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.

Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Administration of CC-93538	Participants were administered CC-93538 360 mg subcutaneously once weekly

Units	Counts
Participants	OG000

Primary

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.

Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Administration of CC-93538	Participants were administered CC-93538 360 mg subcutaneously once weekly

Units	Counts
Participants	OG000

Secondary

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.

Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Administration of CC-93538	Participants were administered CC-93538 360 mg subcutaneously once weekly

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Eosinophilic oesophagitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected367 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0008 events5 affected367 at risk
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Pericarditis	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Omental infarction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Food allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Anaesthetic complication neurological	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Migraine	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Status migrainosus	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected367 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 28.0	Systematic Assessment	EG000449 events40 affected367 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00048 events47 affected367 at risk
Nasopharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00053 events36 affected367 at risk
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00029 events24 affected367 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00049 events40 affected367 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00024 events24 affected367 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00038 events19 affected367 at risk

ID	Term
D057765	Eosinophilic Esophagitis
D005767	Gastrointestinal Diseases
D004941	Esophagitis
D005759	Gastroenteritis
D004802	Eosinophilia
D004935	Esophageal Diseases
D006967	Hypersensitivity

ID	Term
D004066	Digestive System Diseases
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases