New treatment for moderate-to-severe seasonal allergic rhinitis in adults

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

This study is testing a new treatment for adults with moderate to severe seasonal allergies to see if it can help them feel better when other medications haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Longbio Pharma (Industry-sponsored)
• Drugs / interventions: Omalizumab, immunotherapy
• Locations: 17 sites (Beijing, Beijing and 16 other locations)
• Trial ID: NCT06046391 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a novel anti-IgE antibody, LP-003, in combination with standard of care treatments for adults suffering from moderate to severe seasonal allergic rhinitis. Participants must have experienced inadequate symptom control despite using nasal corticosteroids and/or antihistamines in the past two pollen seasons. The study will compare different doses of LP-003 against a placebo to determine its effectiveness in alleviating symptoms. The goal is to provide a more effective treatment option for patients who do not respond well to current therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with moderate to severe seasonal allergic rhinitis that is inadequately controlled despite existing treatments.

Not a fit: Patients with mild allergic rhinitis or those who have well-controlled symptoms with current therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptom control for patients with seasonal allergic rhinitis who currently have limited options.

How similar studies have performed: Previous studies have shown success with anti-IgE therapies for allergic rhinitis, indicating a promising approach for this novel treatment.

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

Where this trial is running

Beijing, Beijing and 16 other locations

• Beijing Shijitan Hospital — Beijing, Beijing, China (Recruiting)
• Dongfang Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Peking University Third Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Zhengzhou central hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Changchun University of Chinese Medicine Affiliated Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• Tonghua central hospital — Tonghua, Jilin, China (Not_yet_recruiting)
• Yan Bian Chao Yi Hospital — Yanbian, Jilin, China (Not_yet_recruiting)
• Yanbian University hospital — Yanji, Jilin, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Yinchuan Peoples Hospital — Yinchuan, Ningxia, China (Not_yet_recruiting)
• Zibo central hospital — Zibo, Shandong, China (Not_yet_recruiting)
• Linfen Peoples Hospital — Linfen, Shanxi, China (Not_yet_recruiting)
• Second hospital of Shanxi Medical University University — Taiyuan, Shanxi, China (Not_yet_recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Xidian group hospital — Xi'an, Shanxi, China (Not_yet_recruiting)
• Tianjin Peoples Hospital — Tianjing, Tianjing, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hongzhou Yang

Conditions Seasonal Allergic Rhinitis