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

NCT04593251 | Completed Phase 1

• 1 other identifier: CALY-CL19-001
• Study Type: interventional
• Target: 73
• Locations: 5 countries
• Sites: 13

Brief 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.

Conditions

Eosinophilic Esophagitis; Celiac Disease

Keywords

anti IL-15; CalypsoBiotech; Calypso Biotech; Celiac Disease; Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse event

  through study completion, an average of 3 months post last dose

Study Arms (2)

CALY-002

EXPERIMENTAL

Biological: CALY-002

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

CALY-002 BIOLOGICAL

1-hour intravenous infusion

CALY-002

Placebo BIOLOGICAL

1-hour intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A. Healthy Subjects:
• Male or female aged between 18 and 50 years (both inclusive)
• 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):
• Male or female ≥ 18 years of age.
• Diagnosis of CeD by intestinal biopsy at least 12 months prior to screening as confirmed by medical records.
• No histological signs of active CeD at screening
• Gluten-free diet (GFD) for at least 12 consecutive months prior to screening
• Willing to undertake a gluten challenge (intake of approximately 3 g of gluten daily) for 56 consecutive days
• 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.
• Part C. Subjects with Eosinophilic Esophagitis (EoE):
• Male or female ≥ 18 years of age.
• Must have endoscopically confirmed and documented diagnosis of EoE
• Should exhibit active symptoms of dysphagia with more than 3 episodes of dysphagia during a period of 2 weeks during screening.
• Must have clinically active disease

You may not qualify if:

• Part A. Healthy Subjects excluded:
• Any significant medical condition, laboratory abnormality, or psychiatric illness
• Any condition that confounds the ability to interpret data from the study.
• Currently receiving or has been previously treated with a biologic agent.
• History of anaphylactic reactions to protein therapeutics.
• Has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require parenteral antibiotic administration.
• Has evidence of SARS-CoV-2 infection and/or subject Is deemed at risk for the coronavirus disease (COVID-19)
• 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:
• A concurrent active autoimmune disease (other than CeD) that requires systematic treatment with immunosuppressants.
• Has severe complication of CeD such as refractory CeD.
• Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
• Is currently receiving or has been previously treated with a biologic agent.
• Has a history of anaphylactic reactions to protein therapeutics.
• Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).

Sponsors & Collaborators

• Calypso Biotech BV: lead

Study Sites (13)

Cliniques Universitaires Saint-Luc - Hospital

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Tampere University Hospital

Tampere, Finland

Location

Charite

Berlin, Germany

Location

Universitatsklinikum Erlangen - Hospital

Erlangen, Germany

Location

Universitätsklinikum Freiburg - Hospital

Freiburg im Breisgau, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

Mainz-GE, Germany

Location

Klinikum rechts der Isa der Technischen Universitaet Muenchen - Hospital

Munich, Germany

Location

AMC

Amsterdam, Netherlands

Location

Ziekenhuis Rijnstate - Hospital

Arnhem, Netherlands

Location

Maastricht University Medical Center - Hospital

Maastricht, Netherlands

Location

Alesund Hospital

Ålesund, Norway

Location

Oslo University Hospital HF

Oslo, Norway

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Celiac Disease

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: September 28, 2020
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

NO (2); NL (3); BE (2); FI (1); DE (5)