New drug aims to quiet chronic hives
NCT ID NCT07717905
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 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 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
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.
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The places running it
10 sites. The list below names each one and where it is.
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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
Locations
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Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510440, China
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Hangzhou Third People's Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310009, China
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Jingzhou Central Hospital
NOT_YET_RECRUITINGJinzhou, Hubei, 434020, China
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Peking University People's Hospital, Beijing
RECRUITINGBeijing, Beijing Municipality, 100032, China
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The First Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
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The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510260, China
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The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITINGWuhu, Anhui, 241001, China
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The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi’an, Shanxi, 710114, China
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The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030000, China
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Wuxi Second People's Hospital,
NOT_YET_RECRUITINGWuxi, Jiangsu, 214002, China
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Other studies related to the condition(s) this trial covers.
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- New pill for chronic hives enters first human tests
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- New drug HRS-3095 aims to soothe stubborn hives