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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LP-003 dose 1
LP-003 dose 2
Placebo
Sponsored by
Longbio Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Beijing Shijitan HospitalRecruiting
  • Dongfang Hospital
  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • Zhengzhou central hospital
  • Changchun University of Chinese Medicine Affiliated Hospital
  • Tonghua central hospital
  • Yan Bian Chao Yi Hospital
  • Yanbian University hospital
  • Shengjing Hospital of China Medical University
  • Yinchuan Peoples Hospital
  • Zibo central hospital
  • Linfen Peoples Hospital
  • Second hospital of Shanxi Medical University University
  • The First Hospital of Shanxi Medical University
  • Xidian group hospital
  • Tianjin Peoples Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LP-003 dose 1

LP-003 dose 2

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
June 27, 2023
Last Updated
September 18, 2023
Sponsor
Longbio Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT06046391
Brief Title
Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Longbio Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LP-003 dose 1
Arm Type
Experimental
Arm Description
Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
Arm Title
LP-003 dose 2
Arm Type
Experimental
Arm Description
Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible patients randomized to this arm received placebo subcutaneously for 8 weeks
Intervention Type
Biological
Intervention Name(s)
LP-003 dose 1
Intervention Description
Liquid in vial
Intervention Type
Biological
Intervention Name(s)
LP-003 dose 2
Intervention Description
Liquid in vial
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Liquid in vial
Primary Outcome Measure Information:
Title
Mean nasal symptom score
Description
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.
Time Frame
peak pollen period(estimated average 4 weeks)
Secondary Outcome Measure Information:
Title
Daily nasal symptom medication score
Description
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.
Time Frame
peak pollen period(estimated average 4 weeks)
Title
Daily nasal symptom medication score
Description
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
Time Frame
pollen period(estimated average 10 weeks)
Title
Daily ocular symptom medication score
Description
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.
Time Frame
pollen period(estimated average 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhou Yang
Phone
021-58372390
Email
yanghz@longbio.com
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyan Wang
Facility Name
Dongfang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Ding
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Guan
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junxiu Liu
Facility Name
Zhengzhou central hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujie Li
Facility Name
Changchun University of Chinese Medicine Affiliated Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Han
Facility Name
Tonghua central hospital
City
Tonghua
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaowu Dong
Facility Name
Yan Bian Chao Yi Hospital
City
Yanbian
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqiang Zhang
Facility Name
Yanbian University hospital
City
Yanji
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongde Jin
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyu Wei
Facility Name
Yinchuan Peoples Hospital
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruixia Ma
Facility Name
Zibo central hospital
City
Zibo
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daoliang Sun
Facility Name
Linfen Peoples Hospital
City
Linfen
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunqiang Dou
Facility Name
Second hospital of Shanxi Medical University University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinmei Xue
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Feng
Facility Name
Xidian group hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jizhou Sun
Facility Name
Tianjin Peoples Hospital
City
Tianjing
State/Province
Tianjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jixiang Liu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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