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Clinical Trials/NL-OMON52682
NL-OMON52682
Recruiting
Not Applicable

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 COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS - CALY-CL19-001

Calypso Biotech BV0 sites6 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Calypso Biotech BV
Enrollment
6
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •For inclusion in Part B of the study, a subject with CeD should meet all of the
  • •following criteria:
  • •1\. Subject is a male or female \>\= 18 years of age, at the time of signing the
  • •2\. Subject has a BMI between \> 17\.5 and \< 35\.0 kg/m2 (both inclusive).
  • •3\. Subject must be willing to consent to all study\-related procedures and
  • •visits, including a minimum of 2 endoscopy procedures with small intestine
  • •biopsies during study participation. Subject must have signed an ICF indicating
  • •that he/she understands the purpose of and procedures required for the study
  • •and is willing to participate in the study.
  • •4\. Subject must have a diagnosis of CeD by intestinal biopsy at least 12 months

Exclusion Criteria

  • •A subject with CeD will not be eligible for inclusion in Part B of this study
  • •if any of the following criteria apply:
  • •1\. Subject has a concurrent active autoimmune disease (other than CeD) that
  • •requires systematic treatment with immunosuppressants. Note: Inclusion of
  • •subjects with a history of autoimmune disease without symptoms or treatment for
  • •more than 3 years or subjects with autoimmune thyroiditis that is well
  • •controlled with levothyroxine substitutions can be discussed with the medical
  • •2\. Subject has severe complication of CeD such as refractory CeD.
  • •3\. Subject has active dermatitis herpetiformis.
  • •4\. Subject has active (microscopic) colitis with clinical signs of

Outcomes

Primary Outcomes

Not specified

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