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

NCT ID: NCT04593251

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2024-04-02

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.

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.

Conditions

Eosinophilic Esophagitis; Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CALY-002

Group Type: EXPERIMENTAL

CALY-002

Intervention Type: BIOLOGICAL

1-hour intravenous infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

1-hour intravenous infusion

Interventions

CALY-002

1-hour intravenous infusion

Intervention Type: BIOLOGICAL

Placebo

1-hour intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Calypso Biotech BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Maastricht University Medical Center - Hospital

Maastricht, , Netherlands

Alesund Hospital

Ålesund, , Norway

Oslo University Hospital HF

Oslo, , Norway

Countries

Belgium; Finland; Germany; Netherlands; Norway

Other Identifiers

CALY-CL19-001

Identifier Type: -

Identifier Source: org_study_id