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

NCT05510843 | Terminated Phase 1

• 1 other identifier: THB001-01-002
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Chronic Cold Urticaria

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by the incidence and severity of adverse events

  Safety evaluations will include analyses of adverse events by treatment group

  From Day 1 through Week 12

Study Arms (3)

THB001 Dose Level A

EXPERIMENTAL

Drug: THB001

THB001 Dose Level B

EXPERIMENTAL

Drug: THB001

THB001 Dose Level C

EXPERIMENTAL

Drug: THB001

Interventions

THB001 DRUG

100 mg capsules for oral administration

THB001 Dose Level A; THB001 Dose Level B; THB001 Dose Level C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Harmonic Bio, Inc.: lead

Study Sites (2)

Charité - Universitätsmedizin Berlin Institute of Allergology

Berlin, Germany

Location

Centre for Human Drug Research

Leiden, 2333, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: September 6, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 4, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 1 year after last subject last visit.

Locations

NL (1); DE (1)