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

NCT06046391 | Completed Phase 2

• 1 other identifier: P10-LP003-02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 17

Brief 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. 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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (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.

  peak pollen period(estimated average 4 weeks)

Secondary Outcomes (3)

• Daily nasal symptom medication score

  peak pollen period(estimated average 4 weeks)

• Daily nasal symptom medication score

  pollen period(estimated average 10 weeks)

• Daily ocular symptom medication score

  pollen period(estimated average 10 weeks)

Study Arms (3)

LP-003 dose 1

EXPERIMENTAL

Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks

Biological: LP-003 dose 1

LP-003 dose 2

EXPERIMENTAL

Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks

Biological: LP-003 dose 2

Placebo

PLACEBO COMPARATOR

Eligible patients randomized to this arm received placebo subcutaneously for 8 weeks

Biological: Placebo

Interventions

LP-003 dose 1 BIOLOGICAL

Liquid in vial

LP-003 dose 1

LP-003 dose 2 BIOLOGICAL

Liquid in vial

LP-003 dose 2

Placebo BIOLOGICAL

Liquid in vial

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Longbio Pharma: lead

Study Sites (17)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

Dongfang Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Zhengzhou central hospital

Zhengzhou, Henan, China

Location

Changchun University of Chinese Medicine Affiliated Hospital

Changchun, Jilin, China

Location

Tonghua central hospital

Tonghua, Jilin, China

Location

Yan Bian Chao Yi Hospital

Yanbian, Jilin, China

Location

Yanbian University hospital

Yanji, Jilin, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Yinchuan Peoples Hospital

Yinchuan, Ningxia, China

Location

Zibo central hospital

Zibo, Shandong, China

Location

Linfen Peoples Hospital

Linfen, Shanxi, China

Location

Second hospital of Shanxi Medical University University

Taiyuan, Shanxi, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Xidian group hospital

Xi’an, Shanxi, China

Location

Tianjin Peoples Hospital

Tianjing, Tianjing, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: September 21, 2023
• Study Start: July 6, 2023
• Primary Completion: October 19, 2023
• Study Completion: August 6, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)