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New shot could tame stubborn hives that antihistamines Can't

NCT ID NCT07166211

Disease control Sponsor: Keymed Biosciences Co.Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an injectable biologic called CM512 in 48 adults with chronic spontaneous urticaria (CSU) — long-lasting hives and itching that don't get better with standard antihistamines. Participants are randomly assigned to receive either CM512 or a placebo shot, and researchers track how well the drug reduces hives and itch over 16 weeks. The goal is to see if CM512 can offer a new option for people whose hives are hard to control.

What this could mean

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

Active substance
CM512 injection (a biologic drug)
What this could lead to
If it works, this could point toward a new treatment option for people with chronic hives that don't respond well to standard antihistamines.
What could go wrong
This is an early Phase 2 trial with only 48 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being studied.

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 48 people

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

Started

Nov 2025

Expected to finish

Jan 2027

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

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.

Inclusion Criteria: * Voluntarily sign the Informed Consent Form. * Age ≥ 18 years old and ≤ 75 years old. * Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 months. * Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period. * A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 7 days before randomization, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period. * Within 7 days before randomization, UAS7≥16 and ISS7 ≥8. Exclusion Criteria: * Not enough washing-out period for previous therapy. * Planned major surgical procedure during the patient's participation in this study. * Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients). * CM512 has been used before. * Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception. * With any medical or non-medical conditions that are not suitable for participation in this study by investigators.

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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 (CSU)

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

  • Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

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