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New pill could tame stubborn hives

NCT ID NCT07005713

Symptom relief Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This early-stage trial tested an experimental oral drug called BGB-16673 in 34 adults with chronic spontaneous urticaria (CSU), a condition causing persistent hives and itching. The study was double-blind and placebo-controlled, meaning neither patients nor doctors knew who got the real drug. The main goals were to check safety and how the drug moves through the body, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-16673 (an oral drug)
What this could lead to
If successful, this could lead to a new oral treatment option for people with chronic hives that are not controlled by antihistamines.
What could go wrong
This is a very early Phase 1b trial with only 34 participants, focused on safety and dosing. It is too small and early to know if the drug will effectively reduce hives or be safe long-term.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 58 people

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

Started

Jul 2025

Expected to finish

Nov 2026

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 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: Part A * Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6 months before randomization. * The presence of itch and hives for ≥6 consecutive weeks at any time prior to randomization despite the use of second-generation H1-antihistamines * UAS7≥16 and HSS7≥8 during the 7 days before randomization * Participants must not have had any missing UAS7 entry (ISS7 and HSS7) during the 7 days before randomization * Presence of hives must have been documented within 3 months before randomization Part B * Participants must be 18 to 55 years of age and healthy, with no clinically relevant abnormalities. * Body Mass Index (BMI) of 18 to 32 kg/m\^2; and a total body weight \> 50 kg (110 lbs). Exclusion Criteria: Part A * Participants who have a clearly defined, predominating or sole trigger for their chronic urticaria (chronic inducible urticaria), including urticaria factitia (symptomatic dermographism) or cold, heat, solar, pressure, delayed pressure, aquagenic, cholinergic, or contact urticaria. * Other diseases with symptoms of urticaria or angioedema * Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. All Participants * Any uncontrolled disease state, including asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids. * Significant bleeding risk or coagulopathy. * Prior exposure to any BTK inhibitors or protein degraders. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria

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 places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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: •••••@•••••

Locations

  • Chengdu Second Peoples Hospital

    COMPLETED

    Chengdu, Sichuan, 610021, China

  • Dermatology Hospital of Southern Medical University

    COMPLETED

    Guangzhou, Guangdong, China

  • Hangzhou First Peoples Hospital

    COMPLETED

    Hangzhou, Zhejiang, 310006, China

  • Peking University Third Hospital

    COMPLETED

    Beijing, Beijing Municipality, 100000, China

  • The Affiliated Hospital of Qingdao University Branch West Coast

    RECRUITING

    Qingdao, Shandong, 266555, China

  • The First Affiliated Hospital of Chongqing Medical University

    COMPLETED

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Wenzhou Medical University

    COMPLETED

    Wenzhou, Zhejiang, 325000, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    COMPLETED

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital of Central South University

    COMPLETED

    Changsha, Hunan, 410008, China

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