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

Last updated: September 18, 2023
Sponsor: Longbio Pharma
Overall Status: Active - Recruiting

Phase

2

Condition

Nasal Obstruction

Common Cold

Allergy

Treatment

LP-003 dose 1

Placebo

LP-003 dose 2

Clinical Study ID

NCT06046391
P10-LP003-02
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 to 65 years at the screening period
  2. Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelinesfor 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 accumulatefor 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 thenasal mucosa and nasal watery discharge; c. Allergen detection: positive of at least 1allergen skin prick test(SPT) and/or serum-specific IgE within 1 year beforeenrollment, or nasal provocation test positive
  3. Had inadequately controlled symptoms (≥TNSS score of 6 and ≥ nasal congestion score of
  1. of seasonal allergic rhinitis in last two years despite the use of nasalcorticosteroid or in combination of one anti-histamine recommended by Guidelines.
  1. Having any nasal symptom last for at least 2 days or any nasal and eye symptom lastfor at least one day, and ≥TNSS score of 1
  2. Subjects (including partners) have no pregnancy and sperm, egg donation plan andvoluntarily take one or more non-pharmaceutical measures for contraception, such ascomplete abstinence, intrauterine ring, partner ligation at period from drugadministration to 6 months after the last study drug administration
  3. voluntary participation in this trial and signing the informed consent form

Exclusion

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, vasomotorrhinitis, Nonallergic rhinitis with eosinophilia syndrome, acute and chronicsinusitis, rhinitis sicca anterior, atrophic rhinitis, obvious deviation of nasalseptum
  3. Subjects with perennial allergic rhinitis ( except for seasonal allergic rhinitiscombined with perennial allergic rhinitis, which get attacks seasonally )
  4. Subjects who have undergone nasal surgery or sinus surgery within 1 year beforescreening
  5. Subjects who suffer from glaucoma, cataracts, herpes simplex keratitis, infectiousconjunctivitis or currently and other eye infections ( Except for allergicconjunctivitis )
  6. Subjects with active facial or systemic fungal, bacterial, viral or parasiticinfection, and oral candida infection, who still require ongoing treatment
  7. With clinically significant uncontrolled systemic disease (unstable ischemic heartdisease, NYHA class III/IV left ventricular failure, arrhythmias, uncontrolledhypertension, cerebrovascular disease, neurodegenerative disease, other neurologicaldisorders, uncontrolled hypothyroidism or hyperthyroidism and other autoimmunedisorders, hypokalemia, hyperadrenergic status, diagnosed as a malignancy in the past,except for basal cell carcinoma or squamous cell skin cancer ) ; History of myocardialinfarction (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 monthsprior 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 1week prior to the screening
  12. Subjects who have taken traditional Chinese medicine for allergic rhinitis within 7days prior to the screening
  13. Subjects who have received allergen immunotherapy within half of year prior to thescreening (in treatment), or who have received allergen immunotherapy within 3 yearsprior to the screening ( completed treatment )
  14. During the study period, in addition to standard treatment concomitant drugs andsalvage therapy drugs specified in the protocol. Subjects are prohibited from takingmedications such as anticholinergics (oral and intranasal anticholinergics, includingipratropium 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 fillin diary cards correctly, and use of prohibited medications
  17. Who combined with nerve and mental illness that could not or unwilling to follow thestudy, and with disabilities as prescribed by law (blind, deaf, mute, mentallydisabled, mentally disabled, etc.)
  18. Who plan to travel to other regions in which there is no allergic pollen during thestudy 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 beappropriate for participating the study

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: LP-003 dose 1
Phase: 2
Study Start date:
July 06, 2023
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • Beijing Shijitan Hospital

    Beijing, Beijing 100038
    China

    Active - Recruiting

  • Dongfang Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Zhengzhou central hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Changchun University of Chinese Medicine Affiliated Hospital

    Changchun, Jilin
    China

    Site Not Available

  • Tonghua central hospital

    Tonghua, Jilin
    China

    Site Not Available

  • Yan Bian Chao Yi Hospital

    Yanbian, Jilin
    China

    Site Not Available

  • Yanbian University hospital

    Yanji, Jilin
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Yinchuan Peoples Hospital

    Yinchuan, Ningxia
    China

    Site Not Available

  • Zibo central hospital

    Zibo, Shandong
    China

    Site Not Available

  • Linfen Peoples Hospital

    Linfen, Shanxi
    China

    Site Not Available

  • Second hospital of Shanxi Medical University University

    Taiyuan, Shanxi
    China

    Site Not Available

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • Xidian group hospital

    Xi'an, Shanxi
    China

    Site Not Available

  • Tianjin Peoples Hospital

    Tianjing, Tianjing
    China

    Site Not Available

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