Seasonal Allergic RhinitisPhase 3NCT07291284
Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis
A Phase 3 study testing LP-003 in people with Seasonal Allergic Rhinitis, run by Longbio Pharma at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- LP-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 years
- Subjects with SAR for at least 2 years
- At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period
- Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening
- Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization
Who cannot join
- Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis
- Subjects with perennial allergic rhinitis (PAR)
- Underwent any nasal or sinus surgery within 1 year prior to screening
- Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections
- Clinically significant conditions upon the judgement of investigator
- Subjects with concomitant asthma who, upon the judgement of investigator, require inhaled corticosteroid treatment during the study
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- The laboratory results at screening: a) white blood cell (WBC) < 2.5×10^9/L; b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ×upper limit of normal (ULN) or total bilirubin > 1.5 ×ULN; c) Serum creatinine (Cr) > 1.5 × ULN
- Received treatment with similar drugs (e.g., Omalizumab) or used LP-003 Injection within 6 months prior to screening
- Received systemic glucocorticoids within 4 weeks prior to screening
- Received intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, or antihistamine medications within 1 week prior to randomization
- Received traditional Chinese medicine treatment for allergic rhinitis within the 7 days prior to randomization
- Received allergen immunotherapy within 6 months prior to screening (for those who have not completed the therapy), or within 3 years prior to screening (for those who have completed the therapy)
- Subjects for whom exposure to allergens in the home or work environment are expected to undergo significant changes during the trial, as assessed by the investigator, which may interfere with the evaluation of efficacy
- Subjects planning to travel outside their area of residence during the trial to an area without pathogenic pollen, for either 2 consecutive days or a total duration exceeding three days
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)
Beijing
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis Inadequately Controlled by Standard-of-care
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- LP-003, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003Biological
Participants were administered LP-003 via subcutaneous injection every 4 weeks.
PlaceboBiological
Participants were administered Placebo via subcutaneous injection every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: LP-003 | Experimental | Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks. Receives: Biological: LP-003 |
| Placebo Comparator：Placebo | Placebo comparator | Participants received subcutaneous of Placebo Injection once every 4 weeks. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity.
Measured: Up to 4 Months
Secondary outcomes (8)
Mean daily rTNSS during the pollen period (PP)
Measured: Up to 4 Months
Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP
Measured: Up to 4 Months
Mean daily iTNSS during the PP
Measured: Up to 4 Months
Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP
Integrates daily rTNSS (4 nasal symptoms, 0-3 each, total 0-12) and rescue medication score (0 for no rescue use and 1 for rescue use).
Measured: Up to 4 Months
Mean daily total ocular symptom score (TOSS) during the PPP
It is derived from 2 individual ocular symptoms (itching/burning/redness, and tearing/watering), and each symptom is scored on a 0-3 scale. The daily TOSS is the sum of the two items, ranging from 0 (no symptoms) to 6 (maximum severity) per day.
Measured: Up to 4 Months
Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP
Integrates daily TOSS (2 individual ocular symptoms, 0-3 each, total 0-6) and rescue medication score (0 for no rescue use and 1 for rescue use).
Measured: Up to 4 Months
Mean daily rescue medication score (RMS) during the PPP
The RSM is assessed based on the usage of montelukast sodium tablets, with a scoring rule of 0 points for no use and 1 point for use on the day. The mean daily RSM during the PPP is calculated as the sum of the cumulative RSM during the PPP divided by the number of days in the PPP.
Measured: Up to 4 Months
Incidence of adverse events (AEs)
Measured: Up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Aug 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xueyan Wang, Principal investigator, Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291284
- Sponsor's protocol ID
- P10-LP003-04
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis Inadequately Controlled by Standard-of-care
- ClinicalTrials.gov ID
- NCT07291284
- Acronym / sponsor ID
- P10-LP003-04
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: LP-003 | Experimental | Biological: LP-003Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks. |
| Placebo Comparator：Placebo | Placebo comparator | Biological: PlaceboParticipants received subcutaneous of Placebo Injection once every 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18 to 65 years
- Subjects with SAR for at least 2 years
- At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period
- Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening
- Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization
Key exclusion criteria (14 listed)
- Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis
- Subjects with perennial allergic rhinitis (PAR)
- Underwent any nasal or sinus surgery within 1 year prior to screening
- Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections
- Clinically significant conditions upon the judgement of investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-003Participants were administered LP-003 via subcutaneous injection every 4 weeks. | Biological | Experimental: LP-003 |
| PlaceboParticipants were administered Placebo via subcutaneous injection every 4 weeks | Biological | Placebo Comparator：Placebo |
Primary outcome
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
Time frame: Up to 4 Months
The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity.
8 secondary outcomes
Mean daily rTNSS during the pollen period (PP)
Time frame: Up to 4 Months
Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP
Time frame: Up to 4 Months
Mean daily iTNSS during the PP
Time frame: Up to 4 Months
Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP
Time frame: Up to 4 Months
Mean daily total ocular symptom score (TOSS) during the PPP
Time frame: Up to 4 Months
Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP
Time frame: Up to 4 Months
Mean daily rescue medication score (RMS) during the PPP
Time frame: Up to 4 Months
Incidence of adverse events (AEs)
Time frame: Up to Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueyan Wang principal investigator
Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LP-003 in people with Seasonal Allergic Rhinitis, run by Longbio Pharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP) (time frame: Up to 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.