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

• ClinicalTrials.gov Identifier: NCT04593251
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: April 9, 2024
• Sponsor: Calypso Biotech BV
• Information provided by (Responsible Party): Calypso Biotech BV

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis; Celiac Disease	Biological: CALY-002; Biological: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 28, 2020
• Actual Primary Completion Date: April 2, 2024
• Actual Study Completion Date: April 2, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: CALY-002	Biological: CALY-002; 1-hour intravenous infusion
Placebo Comparator: Placebo	Biological: Placebo; 1-hour intravenous infusion

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment-emergent adverse event [ Time Frame: through study completion, an average of 3 months post last dose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

• Part C. Subjects with Eosinophilic Esophagitis (EoE):

  1. Male or female ≥ 18 years of age.
  2. Must have endoscopically confirmed and documented diagnosis of EoE
  3. Should exhibit active symptoms of dysphagia with more than 3 episodes of dysphagia during a period of 2 weeks during screening.
  4. Must have clinically active disease
  5. Must have had a relapsed EoE or did not respond after first line therapy
  6. Subject 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.

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.
  2. Has severe complication of CeD such as refractory CeD.
  3. Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
  4. Is currently receiving or has been previously treated with a biologic agent.
  5. Has a history of anaphylactic reactions to protein therapeutics.
  6. Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).

• Part C: Subjects with Eosinophilic Esophagitis (EoE) excluded:

  1. Has a hyper-eosinophilic syndrome.
  2. Has a concurrent active autoimmune disease (other than EoE) that requires treatment with immunosuppressants.
  3. Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
  4. Currently receiving or has been previously treated with a biologic agent.
  5. Has a history of anaphylactic reactions to protein therapeutics.
  6. Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).

Contacts and Locations

Locations

Belgium

Cliniques Universitaires Saint-Luc - Hospital

Brussel, Belgium

UZ Leuven

Leuven, Belgium

Finland

Tampere University Hospital

Tampere, Finland

Germany

Charite

Berlin, Germany

Universitatsklinikum Erlangen - Hospital

Erlangen, Germany

Universitätsklinikum Freiburg - Hospital

Freiburg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

Mainz-GE, Germany

Klinikum rechts der Isa der Technischen Universitaet Muenchen - Hospital

Munich, Germany

Netherlands

AMC

Amsterdam, Netherlands

Ziekenhuis Rijnstate - Hospital

Arnhem, Netherlands

Maastricht University Medical Center - Hospital

Maastricht, Netherlands

Norway

Oslo University Hospital HF

Oslo, Norway

Alesund Hospital

Ålesund, Norway

Sponsors and Collaborators

Calypso Biotech BV

More Information

• Responsible Party: Calypso Biotech BV
• ClinicalTrials.gov Identifier: NCT04593251
• Other Study ID Numbers: CALY-CL19-001
• First Posted: October 19, 2020
• Last Update Posted: April 9, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Calypso Biotech BV:

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

Additional relevant MeSH terms:

Esophagitis; Celiac Disease; Eosinophilic Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases