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Cendakimab

Phase 1

Eosinophilic Esophagitis | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Dec 20, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Cendakimab · 3 trials · 3 indications

Phase 1 3
NCT05638282A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy ParticipantsHealthy Participants
COMPLETED25 Analytics
NCT05175352A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving CendakimabEosinophilic Esophagitis
COMPLETED16 Analytics
NCT05337345A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy ParticipantsHealthy Volunteers
COMPLETED104 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants
Healthy ParticipantsUnlock trial analytics
PHASE1COMPLETED
A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab
Eosinophilic EsophagitisUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Serum Concentration (Cmax)
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Predose and at multiple timepoints (up to 105 days) after dosing
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Up to 18 Weeks
Maximum observed concentration (Cmax)
Up to Day 105
Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 105
AUC from time zero extrapolated to infinite time (AUC(INF))
Up to Day 105

Secondary Endpoints

Number of Participants with Treatment-emergent Adverse Events
Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Screening (Days -28 to -1) through Day 105
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CendakimabEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Administration of Cendakimab and Cytochrome P450 (CYP) substratesEXPERIMENTAL -
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -

Interventions

NameTypeDescription
CendakimabDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
CYP substratesDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be Chinese (both biological parents are ethnically Chinese). * Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2. * Body weight ≥ 50.0 kg. Exclusion Criteria: * History of clinically...

Countries:ChinaUnited States
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Frequently asked questions about Cendakimab

What is Cendakimab used for?

Cendakimab is an investigational small molecule being studied for gastrointestinal conditions, specifically eosinophilic esophagitis. It has also been evaluated in healthy participants and healthy volunteers in early-stage clinical trials. The drug is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

Who makes Cendakimab?

Cendakimab is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy participants and in adults with eosinophilic esophagitis.

What phase is Cendakimab in?

Cendakimab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed in healthy volunteers and in participants with eosinophilic esophagitis.

What clinical trials is Cendakimab in?

Cendakimab has been studied in three completed Phase 1 trials. NCT05175352 evaluated potential drug-drug interactions in adults with eosinophilic esophagitis. NCT05337345 assessed drug levels after subcutaneous delivery in healthy participants. NCT05638282 evaluated safety and tolerability in Chinese healthy participants.

Is Cendakimab a small molecule?

Yes, Cendakimab is a small molecule therapeutic. It is being developed for gastrointestinal indications, with clinical trials focusing on eosinophilic esophagitis and healthy volunteer studies. The drug is administered subcutaneously, as indicated in one of its clinical trials.