TerminatedPhase 1

A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria

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.

Germany, Netherlands5 participantsStarted 2022-09-06

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Safety as assessed by the incidence and severity of adverse events

Timeframe: From Day 1 through Week 12

Trial details

NCT IDNCT05510843

SponsorThird Harmonic Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-30

View on ClinicalTrials.gov More Chronic Cold Urticaria trials