New allergy shot shows promise for those failed by standard meds
NCT ID NCT06046391
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called LP-003 in 180 adults with moderate to severe seasonal allergic rhinitis (hay fever) that wasn't well controlled by usual treatments like antihistamines or nasal sprays. LP-003 is an antibody that blocks IgE, a key driver of allergic reactions, and is designed to be stronger and last longer than existing options. Participants received either LP-003 or a placebo for 12 weeks, and researchers tracked their nasal symptoms (itching, sneezing, runny nose, congestion) using daily diaries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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180 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
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Changchun University of Chinese Medicine Affiliated Hospital
Changchun, Jilin, China
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Dongfang Hospital
Beijing, Beijing Municipality, China
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Linfen Peoples Hospital
Linfen, Shanxi, China
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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Peking University Third Hospital
Beijing, Beijing Municipality, China
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Second hospital of Shanxi Medical University University
Taiyuan, Shanxi, China
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
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The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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Tianjin Peoples Hospital
Tianjing, Tianjing, China
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Tonghua central hospital
Tonghua, Jilin, China
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Xidian group hospital
Xi’an, Shanxi, China
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Yan Bian Chao Yi Hospital
Yanbian, Jilin, China
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Yanbian University hospital
Yanji, Jilin, China
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Yinchuan Peoples Hospital
Yinchuan, Ningxia, China
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Zhengzhou central hospital
Zhengzhou, Henan, China
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Zibo central hospital
Zibo, Shandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Six-Dose drug stop grass pollen allergies in their tracks?
- Can a new nasal spray tame seasonal allergy misery?
- Can a pinpoint pollen dose unmask allergy triggers?
- New allergy pill could offer relief from sneezing and stuffy nose
- New injection could tame seasonal allergy symptoms for those failed by standard treatments
- New shot for teen hay fever? early trial underway