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

Phase 1

Terminated

• Conditions: Chronic Cold Urticaria
• Interventions: Drug: THB001

• Registration Number: NCT05510843
• Lead Sponsor: Third Harmonic Bio, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-09-06
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
THB001 Dose Level A	THB001	-
THB001 Dose Level B	THB001	-
THB001 Dose Level C	THB001	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands

Charité - Universitätsmedizin Berlin Institute of Allergology; 🇩🇪 Berlin, Germany