New drug aims to quiet chronic hives

NCT ID NCT07717905

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests an experimental drug called BBT001 in adults with chronic spontaneous urticaria, a condition causing frequent hives without a clear trigger. Participants receive multiple doses of BBT001 or a placebo to see if it is safe and helps control symptoms. The trial focuses on safety, how the drug moves through the body, and its potential to reduce hive activity.

What this could mean

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

Active substance
an experimental drug called BBT001
What this could lead to
If successful, BBT001 could offer a new treatment option for people with chronic hives that are not controlled by standard antihistamines.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

Jun 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 75 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: key inclusion criteria: 1)Male or female 18 to 75 years (inclusive) of age at time of consent. 2)Capped weight to be no more than 125 kg at screening.3)UAS7\>=16; 4)Patients must have been on daily stable doses of H1-AH;5) Written informed consent obtained from the participant prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization. Exclusion Criteria: key exclusion criteria: 1)Inducible urticaria ; 2) Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis ;3) Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes; 4)History of herpes simplex infection; 5 )Serological abnormalities of infection at screening . \-

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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 places running it

    10 sites. The list below names each one and where it is.

  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

Locations

  • Dermatology Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510440, China

  • Hangzhou Third People's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Jingzhou Central Hospital

    NOT_YET_RECRUITING

    Jinzhou, Hubei, 434020, China

  • Peking University People's Hospital, Beijing

    RECRUITING

    Beijing, Beijing Municipality, 100032, China

  • The First Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510260, China

  • The Second Affiliated Hospital of Wannan Medical College

    NOT_YET_RECRUITING

    Wuhu, Anhui, 241001, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710114, China

  • The Second Hospital of Shanxi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Wuxi Second People's Hospital,

    NOT_YET_RECRUITING

    Wuxi, Jiangsu, 214002, China

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