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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

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

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 an open label multiple dose expansion cohort in participants with Eosinophilic Esophagitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 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
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


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

Placebo Comparator: Placebo Biological: Placebo
1-hour intravenous infusion




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593251


Contacts
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Contact: Josefin-Beate Holz, Dr. med. +41 225523307 info@calypsobiotech.com

Locations
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Germany
Charite Recruiting
Berlin, Germany
Sponsors and Collaborators
Calypso Biotech BV
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Responsible Party: Calypso Biotech BV
ClinicalTrials.gov Identifier: NCT04593251    
Other Study ID Numbers: CALY-CL19-001
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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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
Additional relevant MeSH terms:
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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