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New shot could stop chronic hives when antihistamines fail

NCT ID NCT06228560

Disease control Sponsor: Longbio Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested a new injectable drug called LP-003 in 202 adults with chronic spontaneous urticaria (long-lasting hives and itching) that standard antihistamines couldn't control. The study compared LP-003 to a placebo and to an existing drug (omalizumab) to see if it could completely stop wheals and itching by week 12. The goal is to find a better option for people whose hives don't respond to usual treatments.

What this could mean

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

Active substance
LP-003 (an injectable biologic drug)
What this could lead to
If successful, LP-003 could offer a new treatment option for people with chronic hives that don't respond to standard antihistamines.
What could go wrong
This is an early Phase 2 study with only 202 participants, so results may not hold up in larger trials. The drug may cause side effects or not work for everyone.

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

202 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

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: 1. Aged 18 to 75 years at the screening period. 2. Presence of wheals with itching for ≥ 6 weeks prior to randomization. At the screening visit, subjects had taken double or more than the approved dose, or a combination of two or more H1 antihistamines for the treatment of chronic spontaneous urticaria for at least 2 weeks. Within the 7 days preceding randomization, the Urticaria Activity Score 7 (UAS7) was ≥16 (range 0-42), Itch Severity Score 7 (ISS7) was ≥8 (range 0-21), at least one UAS (range 0-6) was ≥4 on any screening visit day, and there must be a current record of medication use. 3. Subjects must not miss more than one diary record (morning or night) within 7 days prior to randomization (day 1), and are willing and able to complete daily symptom electronic diary records during the study period; 4. Male participants and their partners or female participants must agree to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial period and within 6 months after the end of the trial and have no plans for sperm or egg donation. 5. Agree to participate in this clinical trial and voluntarily sign an informed consent form. Exclusion Criteria: 1. The subject has a primary or sole trigger for chronic urticaria (chronic Induced urticaria), including artificial urticaria (symptomatic skin scratch disease), cold, heat, sun, pressure, delayed pressure, water, cholinergic, or contact urticaria; 2. Other medical conditions accompanied by symptoms of urticaria or angioedema including, but not limited to, urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria; 3. Any other dermatologic condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the judgment of the Investigator may affect the evaluation of the study and the results of the study; 4. Subjects with clinically significant conditions such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, cardiac arrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative, or other neurological disorders, uncontrolled hypothyroidism and hyperthyroidism and other autoimmune disorders, hypokalemia, hyper adrenergic state; past diagnosis of malignancy (other than basal cell carcinoma or squamous cell skin cancer); history of myocardial infarction within 12 months prior to screening; 5. Acute active infections requiring treatment at screening, including but not limited to, pulmonary infections, tuberculosis; 6. Positive hepatitis B surface antigen or hepatitis B core antibody (except for HBV-DNA testing below the lower limit of the research center's test) at screening; positive hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, and anti-syphilis helical antibody (TP-Ab) (except for those who are negative for RPR or TRUST); 7. Clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other abnormalities identified during the Screening Period that may affect the interpretation of the study results and/or the safety of the subject; 8. Comorbid neurological or psychiatric disorders that prevent or prevent cooperation; patients with disabilities as defined by law (blindness, deafness, mute, mental retardation, psychiatric disorders, etc.); 9. Major surgery within 8 weeks prior to screening or surgery planned during the study period; 10. Evidence of historical or ongoing alcohol or substance abuse in the 6 months prior to screening; 11. Poor compliance, such as low medication adherence, inability to accurately complete a diary card, or use of prohibited medications; 12. Pregnant women, nursing mothers, or those with recent birth plans; 13. Patients who have participated in clinical trials of other drugs within the last 3 months; 14. Those who are considered by the investigator to be unfit to participate in the clinical trial.

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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

Contacts and locations

Locations

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Hangzhou First People's Hospital

    Hangzhou, China

  • Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

    Nanjing, Jiangsu, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of China Medical University

    Beijing, Beijing Municipality, China

  • The First Affiliated Hospital of PLA Army Medical University

    Chongqing, Chongqing Municipality, China

  • The First Hospital of Peking University

    Beijing, Beijing Municipality, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The Second XiangYa Hospital of Central South University

    Changsha, Hunan, China

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

    Wuhan, Hubei, China

  • Wuhan NO.1 Hospital

    Wuhan, China

  • the Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, China

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Other studies related to the condition(s) this trial covers.