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Chronic Spontaneous UrticariaPhase 2NCT06228560

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment

A Phase 2 study testing LP-003 and Omalizumab in people with Chronic Spontaneous Urticaria, run by Longbio Pharma at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a Phase II, multicenter, randomized, double-blind study to evaluatethe efficacy and safety of LP-003 administered subcutaneously as an add-on therapy for the treatment of adult patients aged 18-75 who have been diagnosed with refractory CSU and who remain symptomatic despitestandard-dose H1 antihistamine… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
LP-003 and Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
17 sitesChina
Study dates
26 Jan 2024to 16 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years at the screening period.
  • 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.
  • 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;
  • 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.
  • Agree to participate in this clinical trial and voluntarily sign an informed consent form.

Who cannot join

  • 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;
  • 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;
  • 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;
  • 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;
  • Acute active infections requiring treatment at screening, including but not limited to, pulmonary infections, tuberculosis;
  • 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);
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  • 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;
  • 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.);
  • Major surgery within 8 weeks prior to screening or surgery planned during the study period;
  • Evidence of historical or ongoing alcohol or substance abuse in the 6 months prior to screening;
  • Poor compliance, such as low medication adherence, inability to accurately complete a diary card, or use of prohibited medications;
  • Pregnant women, nursing mothers, or those with recent birth plans;
  • Patients who have participated in clinical trials of other drugs within the last 3 months;
  • Those who are considered by the investigator to be unfit to participate in the clinical trial.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

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

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of China Medical University

    Beijing, Beijing Municipality

  • The Second XiangYa Hospital of Central South University

    Changsha, Hunan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Hangzhou First People's Hospital

    Hangzhou

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

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

    Nanjing, Jiangsu

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

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

    Wuhan, Hubei

  • Wuhan NO.1 Hospital

    Wuhan

  • the Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

Other trials in China

About this study

Official title: Multi-center,Randomized,Double-blind Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

The study is a Phase II, multicenter, randomized, double-blind study to evaluatethe efficacy and safety of LP-003 administered subcutaneously as an add-on therapy for the treatment of adult patients aged 18-75 who have been diagnosed with refractory CSU and who remain symptomatic despitestandard-dose H1 antihistamine treatment.

Being tested
LP-003, Placebo, Omalizumab
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP-003Biological

    Liquid in vial

  • PlaceboBiological

    Liquid in vial

  • OmalizumabBiological

    Liquid in vial

Study groups in NCT06228560
Study groupRoleWhat they receive
LP-003 group 1ExperimentalParticipants received LP-003 subcutaneously during the 24-week treatment period
Receives: Biological: LP-003
LP-003 group 2ExperimentalParticipants received LP-003 subcutaneously during the 24-week treatment period
Receives: Biological: LP-003
LP-003 group 3ExperimentalParticipants received LP-003 subcutaneously during the 24-week treatment period
Receives: Biological: LP-003
OmalizumabActive comparatorParticipants received omalizumab 300 mg subcutaneously every 4 weeks during the 24-week treatment period
Receives: Biological: Omalizumab
PlaceboPlacebo comparatorParticipants received placebo subcutaneously every 4 weeks during the 24-week treatment period
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12

    Measured: Week 12

Secondary outcomes (8)

  1. The incidence of adverse events during the study

    Measured: 40 weeks

  2. The proportion of participants with no hives (HSS7 = 0) at week 4, 8, 12, 16, 20, 24, 32, and 40

    Measured: Week 4, 8, 12, 16, 20, 24, 32, and 40

  3. The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 4, 8, 16, 20, 24, 32, and 40

    Measured: Week 4, 8, 16, 20, 24, 32, and 40

  4. The proportion of participants achieving complete absence of angioedema (AAS7 = 0) at week 4, 8, 12, 16, 20, 24, 32, and 40

    Measured: Week 4, 8, 12, 16, 20, 24, 32, and 40

  5. The proportion of participants with controlled disease activity (UAS7 ≤ 6) at week 4, 8, 12, 16, 20, 24, 32, and 40

    Measured: Week 4, 8, 12, 16, 20, 24, 32, and 40

  6. Change From Baseline in UAS7, HSS7, ISS7, AAS7 at week 4, 8, 12, 16, 20, 24, 32, and 40

    Measured: Baseline and week 4, 8, 12, 16, 20, 24, 32, and 40

  7. Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at week 4, 8, 12, 16, 20, 24, 32, and 40

    Measured: Baseline and week 4, 8, 12, 16, 20, 24, 32, and 40

  8. Blood concentrations of LP-003, free IgE, total IgE, anti-drug antibodies (ADA), and neutralizing antibodies (Nab) during the study

    Measured: 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start26 Jan 2024
  3. Primary completion17 Apr 2025
  4. Study completion16 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228560
Sponsor's protocol ID
P10-LP003-03
Status last verified
Oct 2026
First submitted
18 Jan 2024
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LP-003 and Omalizumab in people with Chronic Spontaneous Urticaria, run by Longbio Pharma at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06228560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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