New pill aims to quiet chronic hives without the itch
NCT ID NCT07684560
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental tablet called Alpha-0261 in people with chronic spontaneous urticaria (long-lasting hives) and in healthy volunteers. The study checks the drug's safety, how the body processes it, and whether it reduces hive activity and itching. Participants take the tablet or a placebo daily for several weeks while continuing their usual antihistamine treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Alpha-0261
- What this could lead to
- If successful, this could lead to a new oral treatment option for people with chronic hives that is easier to take than current therapies.
- What could go wrong
- This is an early Phase 1 trial with only 48 participants, so safety and effectiveness are not yet proven. 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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
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: * Written informed consent must be obtained before any assessment is performed.(Part 1 and Part 2) * Aged ≥ 18 and ≤ 75, male or female (Part 1). * Diagnosed with CSU prior to screening at least 6 months. (Part 1) * Received stable second-generation H1 antihistamine therapy for at least 2 weeks before randomization, and is willing to maintain the stable treatment regimen throughout the study treatment period. (Part 1) * Aged ≥ 18 and ≤ 55, male or female (Part 2). * Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2. (Part 2) * In general good health. (Part 2) Exclusion Criteria: * Inducible urticaria with identifiable triggers, including dermographism, cold contact urticaria, heat contact urticaria, solar urticaria, pressure urticaria, delayed pressure urticaria, aquagenic urticaria, cholinergic urticaria, or contact urticaria. (Part 1) * Other chronic pruritic skin diseases that may affect the assessment of study outcomes, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. (Part 1) * Other conditions that may cause urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria. (Part 1) * Have a history of any severe allergic reaction or anaphylaxis. (Part 2) * Any condition, which in the investigator's opinion might jeopardize articipant's safety or compliance with the protocol. (Part 2) * Have clinically significant abnormalities on clinical laboratory results. (Part 2)
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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
1 site. 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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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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