Chronic Cold UrticariaPhase 1NCT05510843
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
A Phase 1 study testing THB001 in people with Chronic Cold Urticaria, run by Third Harmonic Bio, Inc. at 2 sites in 2 countries.
Trial summary
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Cold Urticaria
- What is being tested?
- THB001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Sep 2022to 4 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Charité - Universitätsmedizin Berlin Institute of Allergology
Berlin
About this study
Official title: An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
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
- Being tested
- THB001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THB001Drug
100 mg capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| THB001 Dose Level A | Experimental | Not described Receives: Drug: THB001 |
| THB001 Dose Level B | Experimental | Not described Receives: Drug: THB001 |
| THB001 Dose Level C | Experimental | Not described Receives: Drug: THB001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the incidence and severity of adverse events
Safety evaluations will include analyses of adverse events by treatment group
Measured: From Day 1 through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start6 Sep 2022
- Primary completion30 Mar 2023
- Study completion4 Apr 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cold UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Harmonic Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510843
- Sponsor's protocol ID
- THB001-01-002
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of safety (AEs, SAEs) will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
- ClinicalTrials.gov ID
- NCT05510843
- Acronym / sponsor ID
- THB001-01-002
- Conditions
- Chronic Cold Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Third Harmonic Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THB001 Dose Level A | Experimental | Drug: THB001 |
| THB001 Dose Level B | Experimental | Drug: THB001 |
| THB001 Dose Level C | Experimental | Drug: THB001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THB001100 mg capsules for oral administration | Drug | THB001 Dose Level A, THB001 Dose Level B, THB001 Dose Level C |
Primary outcome
Safety as assessed by the incidence and severity of adverse events
Time frame: From Day 1 through Week 12
Safety evaluations will include analyses of adverse events by treatment group
Results and safety
The study was stopped early (reason given: The decision to discontinue the study was made after observing moderate drug induced liver injury in two subjects enrolled in the first dose cohort.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. Results of safety (AEs, SAEs) will be made available.
Related trials for Chronic Cold Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
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RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THB001 in people with Chronic Cold Urticaria, run by Third Harmonic Bio, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The decision to discontinue the study was made after observing moderate drug induced liver injury in two subjects enrolled in the first dose cohort.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by the incidence and severity of adverse events (time frame: From Day 1 through Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.