Back to resultsA Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
Primary Purpose
Chronic Cold Urticaria
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
THB001
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cold Urticaria
Eligibility Criteria
Key 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
Key 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.
Sites / Locations
- Charité - Universitätsmedizin Berlin Institute of Allergology
- Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
THB001 Dose Level A
THB001 Dose Level B
THB001 Dose Level C
Arm Description
Outcomes
Primary Outcome Measures
Safety as assessed by the incidence and severity of adverse events
Safety evaluations will include analyses of adverse events by treatment group
Secondary Outcome Measures
Full Information
NCT ID
NCT05510843
First Posted
August 18, 2022
Last Updated
October 4, 2023
Sponsor
Third Harmonic Bio, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05510843
Brief Title
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
Official Title
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The decision to discontinue the study was made after observing moderate drug induced liver injury in two subjects enrolled in the first dose cohort.
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Third Harmonic Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cold Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THB001 Dose Level A
Arm Type
Experimental
Arm Title
THB001 Dose Level B
Arm Type
Experimental
Arm Title
THB001 Dose Level C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
THB001
Intervention Description
100 mg capsules for oral administration
Primary Outcome Measure Information:
Title
Safety as assessed by the incidence and severity of adverse events
Description
Safety evaluations will include analyses of adverse events by treatment group
Time Frame
From Day 1 through Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Key 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.
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin Institute of Allergology
City
Berlin
Country
Germany
Facility Name
Centre for Human Drug Research
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results of safety (AEs, SAEs) will be made available.
IPD Sharing Time Frame
Within 1 year after last subject last visit.
Learn more about this trial
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
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