Can a new pill silence stubborn hives?
NCT ID NCT07766499
First seen Aug 14, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This trial is testing an experimental oral medication called THB335 in adults with chronic spontaneous urticaria (CSU), a condition marked by persistent hives and itching that standard antihistamines don't fully control. Participants will take THB335 or a placebo alongside their usual antihistamine for 12 weeks. The study aims to see if THB335 can reduce the severity and frequency of hives and itching, potentially offering a new treatment option for those who remain symptomatic.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- THB335, an oral capsule taken alongside a standard antihistamine
- What this could lead to
- If successful, THB335 could offer a new oral option for people with chronic hives that are not controlled by current treatments, potentially improving their quality of life.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The drug may also have side effects or may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Males and females 18 through 85 years. * Diagnosis of chronic spontaneous urticaria (CSU) ≥ 6 months. * Active CSU despite treatment with a second-generation H1 antihistamine. * Weekly Urticaria Activity Score (UAS7) ≥ 16 and ISS7 ≥ 8 during the 7 days before randomization, with sufficient electronic diary entries to calculate the baseline scores. * Body mass index of 18 to 38 kg/m² and minimum body weight of 50 kg for male participants or 45 kg for female participants. * Willing and able to complete the daily electronic diary, attend scheduled study visits, and comply with study procedures. * Participants capable of becoming pregnant or producing sperm must agree to follow the protocol-defined contraception requirements. Key Exclusion Criteria: * Chronic urticaria with an identified cause other than chronic spontaneous urticaria. * Another active skin condition associated with chronic itching that could interfere with the study assessments. * Recent treatment with prohibited immunosuppressive therapy, biologic therapy, a Bruton's tyrosine kinase inhibitor, an investigational drug, or another therapy that inhibits the c-KIT receptor. * Clinically significant hepatic, hematologic, or renal disease or laboratory abnormalities. * Active, chronic, or recurrent infection, including human immunodeficiency virus or viral hepatitis infection. * Clinically significant cardiovascular disease or electrocardiogram abnormality, including clinically significant arrhythmia, prolonged QT interval, familial long QT syndrome, or use of medication known to prolong the QT interval that cannot be discontinued. * History of idiopathic anaphylaxis, a severe allergic reaction that may increase the risk of study participation, or hypersensitivity to the study drug or related compounds. * History of malignancy within the previous 5 years, except successfully treated nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ. * Current or planned use of prohibited medications, including specified inhibitors, inducers, or sensitive substrates of drug-metabolizing enzymes or transporters, or proton pump inhibitors. * Positive urine drug screen at Screening. * Pregnancy or breastfeeding. * Any medical or psychiatric condition that, in the investigator's judgment, could place the participant at increased risk, interfere with the study assessments, or affect the participant's ability to complete the study. Additional eligibility criteria are outlined in the full protocol. The study investigator will review all requirements with potential participants to determine whether they are eligible to participate.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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