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Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis | Clinical Trials | Clareo Health

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Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

NCT04593251•Calypso Biotech BV

View on ClinicalTrials.gov

Summary

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

Detailed Description

This is a multi-site, randomized, placebo controlled single and multiple dose escalation study of an anti-IL-15 mAb (CALY-002). The study initiates as placebo controlled, randomized trial with a single ascending dosing part in healthy subjects and commences with a multiple ascending dosing part in participants with Celiac Disease undergoing a gluten challenge and includes open label multiple dose expansion cohorts in participants with Eosinophilic Esophagitis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part A. Healthy Subjects:
•1. Male or female aged between 18 and 50 years (both inclusive)
•2. Must be healthy on the basis of the physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead electrocardiogram \[ECG\] results) performed at screening, in the opinion of the investigator
•Part B. Subjects with Celiac Disease (CeD):
•1. Male or female ≥ 18 years of age.
•2. Diagnosis of CeD by intestinal biopsy at least 12 months prior to screening as confirmed by medical records.
•3. No histological signs of active CeD at screening
•4. Gluten-free diet (GFD) for at least 12 consecutive months prior to screening
•5. Willing to undertake a gluten challenge (intake of approximately 3 g of gluten daily) for 56 consecutive days
•6. Must be healthy on the basis of physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead ECG results) performed at screening, in the opinion of the investigator.
+7 more criteria

Exclusion Criteria

•Part A. Healthy Subjects excluded:
•1. Any significant medical condition, laboratory abnormality, or psychiatric illness
•2. Any condition that confounds the ability to interpret data from the study.
•3. Currently receiving or has been previously treated with a biologic agent.
•4. History of anaphylactic reactions to protein therapeutics.
•5. Has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require parenteral antibiotic administration.
•6. Has evidence of SARS-CoV-2 infection and/or subject Is deemed at risk for the coronavirus disease (COVID-19)
•7. Has had major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening.
•Part B. Subjects with Celiac Disease (CeD) excluded:
•1. A concurrent active autoimmune disease (other than CeD) that requires systematic treatment with immunosuppressants.
+12 more criteria

Locations (13)

Cliniques Universitaires Saint-Luc - Hospital

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Tampere University Hospital

Tampere, Finland

Charite

Berlin, Germany

Universitatsklinikum Erlangen - Hospital

Erlangen, Germany

Universitätsklinikum Freiburg - Hospital

Freiburg im Breisgau, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

Mainz-GE, Germany

Klinikum rechts der Isa der Technischen Universitaet Muenchen - Hospital

Munich, Germany

AMC

Amsterdam, Netherlands

Ziekenhuis Rijnstate - Hospital

Arnhem, Netherlands

Key Dates

Start Date

September 28, 2020

Primary Completion Date

April 2, 2024

Completion Date

April 2, 2024

Last Updated

April 9, 2024

Enrollment

ACTUAL participants

Conditions

Eosinophilic EsophagitisCeliac Disease

Interventions

CALY-002

BIOLOGICAL

Placebo

BIOLOGICAL

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Study of DONQ52 in Active Celiac Disease

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients