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

NCT ID: NCT06046391

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-08-06

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.

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LP-003 dose 1

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

Group Type: EXPERIMENTAL

LP-003 dose 1

Intervention Type: BIOLOGICAL

Liquid in vial

LP-003 dose 2

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

Group Type: EXPERIMENTAL

LP-003 dose 2

Intervention Type: BIOLOGICAL

Liquid in vial

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Liquid in vial

Interventions

LP-003 dose 1

Liquid in vial

Intervention Type: BIOLOGICAL

LP-003 dose 2

Liquid in vial

Intervention Type: BIOLOGICAL

Placebo

Liquid in vial

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 65 years at the screening period

2. 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

3. 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.

4. 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

5. 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

6. voluntary participation in this trial and signing the informed consent form

Exclusion Criteria

1. History of hypersensitivity to any content of the study drugs or its excipients..

2. 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

3. Subjects with perennial allergic rhinitis ( except for seasonal allergic rhinitis combined with perennial allergic rhinitis, which get attacks seasonally )

4. Subjects who have undergone nasal surgery or sinus surgery within 1 year before screening

5. Subjects who suffer from glaucoma, cataracts, herpes simplex keratitis, infectious conjunctivitis or currently and other eye infections ( Except for allergic conjunctivitis )

6. Subjects with active facial or systemic fungal, bacterial, viral or parasitic infection, and oral candida infection, who still require ongoing treatment

7. 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

8. 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

9. Subjects who have been treated by Omalizumab or other similar drugs within 6 months prior to the screening

10. Subjects who have taken systemic glucocorticoids within 4 weeks prior to the screening

11. Subjects who have taken intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, antihistamines within 1 week prior to the screening

12. Subjects who have taken traditional Chinese medicine for allergic rhinitis within 7 days prior to the screening

13. 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 )

14. 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

15. Subjects with serious organic diseases such as heart, lung, liver, kidney

16. Subjects with poor compliance, such as poor medication compliance, inability to fill in diary cards correctly, and use of prohibited medications

17. 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.)

18. 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

19. Pregnant or lactating women and women who plan pregnancy

20. Participated in other clinical studies within 3 months prior to the start of the study

21. Any condition that the investigator or primary physician believes may not be appropriate for participating the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Longbio Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Dongfang Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Zhengzhou central hospital

Zhengzhou, Henan, China

Changchun University of Chinese Medicine Affiliated Hospital

Changchun, Jilin, China

Tonghua central hospital

Tonghua, Jilin, China

Yan Bian Chao Yi Hospital

Yanbian, Jilin, China

Yanbian University hospital

Yanji, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Yinchuan Peoples Hospital

Yinchuan, Ningxia, China

Zibo central hospital

Zibo, Shandong, China

Linfen Peoples Hospital

Linfen, Shanxi, China

Second hospital of Shanxi Medical University University

Taiyuan, Shanxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Xidian group hospital

Xi’an, Shanxi, China

Tianjin Peoples Hospital

Tianjing, Tianjing, China

Countries

China

Other Identifiers

P10-LP003-02

Identifier Type: -

Identifier Source: org_study_id