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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04593251
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Calypso Biotech BV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis, Celiac Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: CALY-002

Placebo Comparator: Placebo

Interventions

Biological: - CALY-002

1-hour intravenous infusion

Biological: - Placebo

1-hour intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Charite, Berlin, Germany

Status

Recruiting

Address

Charite

Berlin, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

PO Box 544, Ambler, PA 19002

Phone: 215-325-1306

Toll-Free: 844-856-6692

Press Room / Media Inquiries

Contact Information

The information found on this website is not intended to be a replacement or substitute for professional medical treatment or for professional medical advice relative to a specific medical condition. We urge you to always seek the advice of your physician. There is no replacement for personal medical treatment and advice from your personal physician.