AzTrials
AzTrials

Seasonal Allergic RhinitisPhase 2NCT06046391

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult

A Phase 2 study testing LP-003 dose 1 and LP-003 dose 2 in people with Seasonal Allergic Rhinitis, 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
Search all trials

Trial summary

Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (~20%) are not well/adequately controlled. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
LP-003 dose 1 and LP-003 dose 2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
17 sitesChina
Study dates
6 Jul 2023to 6 Aug 2024
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 65 years at the screening period
  • Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022) : a. Clinical symptoms: more than 2 (including 2 items) symptoms of sneezing, rhinorrhea, nasal congestion, nasal itching and other symptoms appear, which last or accumulate for more than 1h per day and may be accompanied by ocular symptoms such as itchy eyes/ tearing/ redness and burning heat sensation; b. Physical signs: pale, edema of the nasal mucosa and nasal watery discharge; c. Allergen detection: positive of at least 1 allergen skin prick test(SPT) and/or serum-specific IgE within 1 year before enrollment, or nasal provocation test positive
  • Had inadequately controlled symptoms (≥TNSS score of 6 and ≥ nasal congestion score of 2) of seasonal allergic rhinitis in last two years despite the use of nasal corticosteroid or in combination of one anti-histamine recommended by Guidelines.
  • Having any nasal symptom last for at least 2 days or any nasal and eye symptom last for at least one day, and ≥TNSS score of 1
  • Subjects (including partners) have no pregnancy and sperm, egg donation plan and voluntarily take one or more non-pharmaceutical measures for contraception, such as complete abstinence, intrauterine ring, partner ligation at period from drug administration to 6 months after the last study drug administration
  • voluntary participation in this trial and signing the informed consent form

Who cannot join

  • History of hypersensitivity to any content of the study drugs or its excipients..
  • Subjects with non-allergic rhinitis combined, such as drug rhinitis, vasomotor rhinitis, Nonallergic rhinitis with eosinophilia syndrome, acute and chronic sinusitis, rhinitis sicca anterior, atrophic rhinitis, obvious deviation of nasal septum
  • Subjects with perennial allergic rhinitis ( except for seasonal allergic rhinitis combined with perennial allergic rhinitis, which get attacks seasonally )
  • Subjects who have undergone nasal surgery or sinus surgery within 1 year before screening
  • Subjects who suffer from glaucoma, cataracts, herpes simplex keratitis, infectious conjunctivitis or currently and other eye infections ( Except for allergic conjunctivitis )
  • Subjects with active facial or systemic fungal, bacterial, viral or parasitic infection, and oral candida infection, who still require ongoing treatment
Show all 21Show fewer
  • With clinically significant uncontrolled systemic disease (unstable ischemic heart disease, NYHA class III/IV left ventricular failure, arrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative disease, other neurological disorders, uncontrolled hypothyroidism or hyperthyroidism and other autoimmune disorders, hypokalemia, hyperadrenergic status, diagnosed as a malignancy in the past, except for basal cell carcinoma or squamous cell skin cancer ) ; History of myocardial infarction (MI) within 1 year prior to the screening
  • In screening period: a) WBC < 2.5×10^9/L, b)AST or ALT > 2.0×ULN or TBIL > 1.5×ULN, c) Cr > 1.5×ULN
  • Subjects who have been treated by Omalizumab or other similar drugs within 6 months prior to the screening
  • Subjects who have taken systemic glucocorticoids within 4 weeks prior to the screening
  • Subjects who have taken intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, antihistamines within 1 week prior to the screening
  • Subjects who have taken traditional Chinese medicine for allergic rhinitis within 7 days prior to the screening
  • Subjects who have received allergen immunotherapy within half of year prior to the screening (in treatment), or who have received allergen immunotherapy within 3 years prior to the screening ( completed treatment )
  • During the study period, in addition to standard treatment concomitant drugs and salvage therapy drugs specified in the protocol. Subjects are prohibited from taking medications such as anticholinergics (oral and intranasal anticholinergics, including ipratropium nasal sprays), glucocorticoids, leukotriene receptor antagonists, antihistamines, mast cell membrane stabilizers, decongestants, nasal saline flushing, tricyclic antidepressants, antiallergic Chinese herbal medicines, immunosuppressants, immunomodulators and immunotherapy
  • Subjects with serious organic diseases such as heart, lung, liver, kidney
  • Subjects with poor compliance, such as poor medication compliance, inability to fill in diary cards correctly, and use of prohibited medications
  • Who combined with nerve and mental illness that could not or unwilling to follow the study, and with disabilities as prescribed by law (blind, deaf, mute, mentally disabled, mentally disabled, etc.)
  • Who plan to travel to other regions in which there is no allergic pollen during the study period for more than two consecutive days or three accumulated days
  • Pregnant or lactating women and women who plan pregnancy
  • Participated in other clinical studies within 3 months prior to the start of the study
  • Any condition that the investigator or primary physician believes may not be appropriate for participating the study

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038

  • Dongfang Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Changchun University of Chinese Medicine Affiliated Hospital

    Changchun, Jilin

  • Linfen Peoples Hospital

    Linfen, Shanxi

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Second hospital of Shanxi Medical University University

    Taiyuan, Shanxi

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Peoples Hospital

    Tianjing, Tianjing

  • Tonghua central hospital

    Tonghua, Jilin

  • Xidian group hospital

    Xi’an, Shanxi

  • Yan Bian Chao Yi Hospital

    Yanbian, Jilin

  • Yanbian University hospital

    Yanji, Jilin

  • Yinchuan Peoples Hospital

    Yinchuan, Ningxia

  • Zhengzhou central hospital

    Zhengzhou, Henan

  • Zibo central hospital

    Zibo, Shandong

Other trials in China

About this study

Official title: A 12 Weeks,Multi-center,Randomized,Double-blind,Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Adult Patients With Inadequately Controlled Moderate to Severe Seasonal Allergic Rhinitis Despite the Current Recommended Therapies

Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (~20%) are not well/adequately controlled. Anti-IgE antibody has been approved to treat moderate to severe AR by PMDA/Japan in 2020, demonstrating the efficacy of IgE blockade in the treatment of allergic rhinitis. The current study presents a novel anti-IgE antibody (LP-003) with higher affinity to IgE, stronger efficacy and longer half-life.

Read the detailed description

The purpose of this study was to evaluate the efficacy and safety of LP-003 in combination with SoC (nasal corticosteroids and/or anti-histamine) in adult patients with Moderate to Severe Seasonal Allergic Rhinitis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids and/or anti-histamine) in the previous 2 pollen seasons.

Being tested
LP-003 dose 1, LP-003 dose 2, Placebo
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

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

  • LP-003 dose 1Biological

    Liquid in vial

  • LP-003 dose 2Biological

    Liquid in vial

  • PlaceboBiological

    Liquid in vial

Study groups in NCT06046391
Study groupRoleWhat they receive
LP-003 dose 1ExperimentalEligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
Receives: Biological: LP-003 dose 1
LP-003 dose 2ExperimentalEligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
Receives: Biological: LP-003 dose 2
PlaceboPlacebo comparatorEligible patients randomized to this arm received placebo subcutaneously for 8 weeks
Receives: Biological: Placebo

What is being measured

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

  1. Mean nasal symptom score

    Nasal symptoms (itchy, sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 3 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of itchy (0-3 point), sneezing (0-3 point), rhinorrhea (0-3 point) and nasal congestion (0-3 point).

    Peak pollen period was defined as the period between the first and last three consecutive days with ≥300 total pollen/1000 mm2 each day.

    Measured: peak pollen period(estimated average 4 weeks)

Secondary outcomes (3)

  1. Daily nasal symptom medication score

    The daily nasal symptom medication score consisted of the sum of the daily nasal symptom severity score (0-12 points) and the daily nasal rescue medication score.

    Measured: peak pollen period(estimated average 4 weeks)

  2. Daily nasal symptom medication score

    The daily nasal symptom medication score consisted of the sum of the daily nasal symptom severity score (0-12 points) and the daily nasal rescue medication score.

    Pollen period was defined as the period between the first day when the total daily pollen count was ≥80 total pollen/1000 mm2 to the first day when the total daily pollen count was <80 total pollen/1000 mm2

    Measured: pollen period(estimated average 10 weeks)

  3. Daily ocular symptom medication score

    Ocular symptoms (itchy eyes/foreign body sensation/redness, tearing) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 3 (intense/severe). Ocular symptom score (0-6 point) consisted of score for severity of itchy eyes/foreign body sensation/redness (0-3 point) and tearing (0-3 point).

    The daily ocular symptom medication score consisted of the sum of the daily ocular symptom severity score (0-6 points) and the daily ocular rescue medication score.

    Measured: pollen period(estimated average 10 weeks)

Timeline

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

  1. First posted21 Sep 2023
  2. Study start6 Jul 2023
  3. Primary completion19 Oct 2023
  4. Study completion6 Aug 2024

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046391
Sponsor's protocol ID
P10-LP003-02
Status last verified
Dec 2025
First submitted
27 Jun 2023
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LP-003 dose 1 and LP-003 dose 2 in people with Seasonal Allergic Rhinitis, 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 6 inclusion and 21 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 15 Dec 2025. 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?

Mean nasal symptom score (time frame: peak pollen period(estimated average 4 weeks)). 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 NCT06046391.

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 15 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in