Chronic Cold Urticaria
Conditions
Brief summary
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
Interventions
DRUGTHB001
100 mg capsules for oral administration
Sponsors
Third Harmonic Bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Women and Men ages 18-75 2. Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment 3. Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits 4. Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording 5. Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions Key
Exclusion criteria
1. A diagnosis of acute urticaria or non-cold chronic inducible urticaria 2. Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others) 3. A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C 4. Clinical laboratory values outside of the normal ranges at the Screening visit 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by the incidence and severity of adverse events | From Day 1 through Week 12 | Safety evaluations will include analyses of adverse events by treatment group |
Countries
Germany, Netherlands
Outcome results
None listed