Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a new pill silence stubborn hives?

NCT ID NCT07766499

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 81 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic idiopathic urticaria are added.

Vår säkerhetsrekommendation!

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Study contacts

  • Contact

    Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.