An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    30
  • sponsor
    Third Harmonic Bio, Inc.
Updated on 21 October 2022

Summary

This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.

Details
Condition Chronic Cold Urticaria
Treatment THB001
Clinical Study IdentifierNCT05510843
SponsorThird Harmonic Bio, Inc.
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women and Men ages 18-75
Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions

Exclusion Criteria

A diagnosis of acute urticaria or non-cold chronic inducible urticaria
Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
Clinical laboratory values outside of the normal ranges at the Screening visit
History of any clinically significant abnormality that would contraindicate participation
There are additional criteria that your study doctor will review with you to confirm you
are eligible for the study
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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