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New allergy shot shows promise for those failed by standard meds

NCT ID NCT06046391

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

180 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2024

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038, China

  • Changchun University of Chinese Medicine Affiliated Hospital

    Changchun, Jilin, China

  • Dongfang Hospital

    Beijing, Beijing Municipality, China

  • Linfen Peoples Hospital

    Linfen, Shanxi, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • Second hospital of Shanxi Medical University University

    Taiyuan, Shanxi, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Tianjin Peoples Hospital

    Tianjing, Tianjing, China

  • Tonghua central hospital

    Tonghua, Jilin, China

  • Xidian group hospital

    Xi’an, Shanxi, China

  • Yan Bian Chao Yi Hospital

    Yanbian, Jilin, China

  • Yanbian University hospital

    Yanji, Jilin, China

  • Yinchuan Peoples Hospital

    Yinchuan, Ningxia, China

  • Zhengzhou central hospital

    Zhengzhou, Henan, China

  • Zibo central hospital

    Zibo, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.