Seasonal Allergic RhinitisPhase 2PumecitinibNCT06837233
A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
A Phase 2 study testing Pumecitinib Nasal Spray 0.3%, Pumecitinib Nasal Spray 0.6% and Pumecitinib nasal spray 0.6%(twice daily) in people with Seasonal Allergic Rhinitis, run by Prime Gene Therapeutics Co., Ltd. at 20 sites in China.
Trial summary
The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research. 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?
- Pumecitinib Nasal Spray 0.3%, Pumecitinib Nasal Spray 0.6% and Pumecitinib nasal spray 0.6%(twice daily)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 20 sitesChina
- Study dates
- 12 Mar 2025to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 (including threshold).
- Reflective total nasal symptom score ( rTNSS) score≥ 6 and retrospective nasal obstruction ≥ 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) ≥ 6
- History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within ≤ 1 year before random enrollment are acceptable).
- Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until one month after the last administration of the investigational medicinal product.
- Willing to sign the informed consent form and abide by the research protocol.
Who cannot join
- Participants are diagnosed of active or latent tuberculosis infection.
- Participants are diagnosed of moderate to severe asthma.
- Participants who had active pulmonary diseases or infections (including but not limited to bronchitis, pneumonia), upper respiratory tract infections or sinus infections within 4 weeks before screening, and/or those who had respiratory infections during the lead-in period.
- Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed.
- Any nasal mucosal erosion, nasal septal ulcer, nasal septal perforation or other nasal diseases that, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc.
- Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis).
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- Participants with facial or systemic fungal, bacterial, viral or parasitic infections, or oral infections that had not been cured and still required continuous treatment within 4 weeks before screening.
- Participants have severe diseases such as central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, which may affect the judgment of efficacy and safety .
- Participants who were infected with human immunodeficiency virus (HIV) at the time of screening, those in the active stage of hepatitis C virus (HCV) infection (anti - HCV positive), those in the active stage of hepatitis B virus (HBV) infection (HBV - DNA > 2000 IU/mL or 10⁴ copies/mL), or those with positive Treponema pallidum antibody indicating an active stage of infection.
- Any drug treatments before lead-in period, such as use of nasal or systemic decongestants and anticholinergic drugs within 3 days, use of antihistamines such as cetirizine, fexofenadine, and loratadine within 5 days, systemic use of glucocorticoids within 4 weeks, or local use of glucocorticoids, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks.
- During the trial, participants who cannot stop using JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except loratadine, which is a rescue drug required during the treatment), leukotriene receptor antagonists, mast cell stabilizers (including sodium cromoglycate, nedocromil sodium, tetrazolium chromone, nedocromil sodium, pemirolast potassium, and tranilast, etc.), anticholinergic drugs, anti - allergic Chinese herbal medicines, and those who cannot stop using nasal irrigation.
- Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening.
- Participants who are known or judged by the investigator to potentially have an allergic reaction to the active ingredients or excipients of the investigational drug.
- Participants who have a history of intolerance to intranasal administration.
- Participants who plan to travel outside the local area for 2 consecutive days or more during the trial.
- Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening.
- Participants who have a history of drug abuse or alcoholism within 1 year prior to screening
- Female participants who are breastfeeding or pregnant at the time of screening
- Reproductive - age participants (male or female) who plan to become pregnant, breastfeed, or donate sperm/eggs during the study or within 1 month after the study ends
- Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Baotou Central Hospital
Baotou, Neimenggu
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Cangzhou Central Hospital
Cangzhou, Hebei
Chifeng Municipal Hospital
Chifeng, Neimenggu
Shandong Second Provincial People's Hospital
Jinan, Shandong
Hebei Petro China Central Hospital
Langfang, Hebei
Liaocheng People's Hospital
Liaocheng, Shandong
Linfen Central Hospital
Linfen, Shanxi
Linfen People's Hospital
Linfen, Shanxi
Luo Yang First People's Hospital
Luoyang, Henan
Shengjing Hospital of China Medical University
Shenyang, Liaoning
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
The Central Hospital of Wuhan
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi
Yantai YuHuangDing Hospital
Yantai, Shandong
Yuncheng Central Hospital
Yuncheng, Shanxi
Zhengzhou Central Hospital
Zhengzhou, Henan
Zibo Central Hospital
Zibo, Shandong
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research.
The goal of this phase IIb study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray across various dosages and administration frequencies for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see which dosage and frequency works to treat moderate to severe seasonal allergic rhinitis.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical study in adults participants aged from 18 to 65 years old (including threshold) with moderate to severe SAR. Approximately 160 participants will be randomized assigned to one of the 4 following groups in a 1:1:1:1 ratio.
PG-011 nasal spray 0.3% ( 0.6mg Pumecitinib) administered twice daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered once daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily, PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered once or twice daily.
Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Pumecitinib Nasal Spray 0.3%, Pumecitinib Nasal Spray 0.6%, Placebo (twice daily), Pumecitinib nasal spray 0.6%(twice daily), Placebo
- Keywords
- SAR, PG-011, Seasonal Allergic Rhinitis, Pumecitinib
- 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.
Pumecitinib Nasal Spray 0.3%Drug
2 sprays in each nostril, twice daily for 14-day treatment period.
Pumecitinib Nasal Spray 0.6%Drug
2 sprays in each nostril, once daily for 14-day treatment period.
Placebo (twice daily)Drug
2 sprays in each nostril, twice daily for 14-day treatment period.
Pumecitinib nasal spray 0.6%(twice daily)Drug
2 sprays in each nostril, twice daily for 14-day treatment period.
PlaceboDrug
2 sprays in each nostril, once daily for 14-day treatment period.
| Study group | Role | What they receive |
|---|---|---|
| PG-011 nasal spray 0.3% (twice daily) | Experimental | 2 sprays in each nostril, twice daily for 14-day treatment period. Receives: Drug: Pumecitinib Nasal Spray 0.3% |
| PG-011 nasal spray 0.6%(once daily) | Experimental | 2 sprays in each nostril, once daily for 14-day treatment period. Receives: Drug: Pumecitinib Nasal Spray 0.6%; Drug: Placebo |
| PG-011 nasal spray 0.6%(twice daily) | Experimental | 2 sprays in each nostril, twice daily for 14-day treatment period. Receives: Drug: Pumecitinib nasal spray 0.6%(twice daily) |
| Vehicle nasal spray(twice daily) | Placebo comparator | 2 sprays in each nostril, twice daily for 14-day treatment period. Receives: Drug: Placebo (twice daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.
Measured: Baseline and Day 14
Secondary outcomes (5)
Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.
Percent change is calculated as (Change from baseline / Baseline result *100).
Measured: Baseline and Day 14
Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period
The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous symptom severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate).The iTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.
Percent change is calculated as (Change from baseline / Baseline result *100).
Measured: Baseline and Day 14
Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period
The reflective Ocular Symptom Total Score (rTOSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of three rocular symptoms (itching/burning, tearing/watering, and redness).Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). . The Total Ocular Symptom Score (TOSS) ranged from 0 to 9. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Percent change is calculated as (Change from baseline / Baseline result *100).
Measured: Baseline and Day 14
Change and percent change from baseline in average instantaneous ocular symptom score (iTOSS) over 14-day treatment period
The instantaneous Total ocular Symptom Score is a scale used to measure ocular symptom severity based on how the participant was feeling just before taking each dose of study medication. Scores ranged from 0 to 9, and calculated as the sum of participant's scoring of three individual ocular symptoms (itching/burning, tearing/watering, and redness) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe).
Percent change is calculated as (Change from baseline / Baseline result *100).
Measured: Baseline and Day 14
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of general activities on day 15
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). Each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses.
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start12 Mar 2025
- Primary completion26 May 2025
- Study completion30 Jun 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Professor, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837233
- Sponsor's protocol ID
- PG-011-SAR-301
- Other IDs
- CTR20250489
- Acronym
- Pumecitinib
- Status last verified
- May 2025
- First submitted
- 14 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06837233
- Acronym / sponsor ID
- Pumecitinib / PG-011-SAR-301
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- SAR, PG-011, Seasonal Allergic Rhinitis, Pumecitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 Feb 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.
The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research.
The goal of this phase IIb study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray across various dosages and administration frequencies for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see which dosage and frequency works to treat moderate to severe seasonal allergic rhinitis.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical study in adults participants aged from 18 to 65 years old (including threshold) with moderate to severe SAR. Approximately 160 participants will be randomized assigned to one of the 4 following groups in a 1:1:1:1 ratio.
PG-011 nasal spray 0.3% ( 0.6mg Pumecitinib) administered twice daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered once daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily, PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered once or twice daily.
Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PG-011 nasal spray 0.3% (twice daily) | Experimental | Drug: Pumecitinib Nasal Spray 0.3%2 sprays in each nostril, twice daily for 14-day treatment period. |
| PG-011 nasal spray 0.6%(once daily) | Experimental | Drug: Pumecitinib Nasal Spray 0.6%, Drug: Placebo2 sprays in each nostril, once daily for 14-day treatment period. |
| PG-011 nasal spray 0.6%(twice daily) | Experimental | Drug: Pumecitinib nasal spray 0.6%(twice daily)2 sprays in each nostril, twice daily for 14-day treatment period. |
| Vehicle nasal spray(twice daily) | Placebo comparator | Drug: Placebo (twice daily)2 sprays in each nostril, twice daily for 14-day treatment period. |
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 (including threshold).
- Reflective total nasal symptom score ( rTNSS) score≥ 6 and retrospective nasal obstruction ≥ 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) ≥ 6
- History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within ≤ 1 year before random enrollment are acceptable).
- Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until one month after the last administration of the investigational medicinal product.
- Willing to sign the informed consent form and abide by the research protocol.
Key exclusion criteria (20 listed)
- Participants are diagnosed of active or latent tuberculosis infection.
- Participants are diagnosed of moderate to severe asthma.
- Participants who had active pulmonary diseases or infections (including but not limited to bronchitis, pneumonia), upper respiratory tract infections or sinus infections within 4 weeks before screening, and/or those who had respiratory infections during the lead-in period.
- Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed.
- Any nasal mucosal erosion, nasal septal ulcer, nasal septal perforation or other nasal diseases that, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc.
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 |
|---|---|---|
| Pumecitinib Nasal Spray 0.3%2 sprays in each nostril, twice daily for 14-day treatment period. | Drug | PG-011 nasal spray 0.3% (twice daily) |
| Pumecitinib Nasal Spray 0.6%2 sprays in each nostril, once daily for 14-day treatment period. | Drug | PG-011 nasal spray 0.6%(once daily) |
| Placebo (twice daily)2 sprays in each nostril, twice daily for 14-day treatment period. | Drug | Vehicle nasal spray(twice daily) |
| Pumecitinib nasal spray 0.6%(twice daily)2 sprays in each nostril, twice daily for 14-day treatment period. | Drug | PG-011 nasal spray 0.6%(twice daily) |
| Placebo2 sprays in each nostril, once daily for 14-day treatment period. | Drug | PG-011 nasal spray 0.6%(once daily) |
Primary outcome
Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
Time frame: Baseline and Day 14
The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.
5 secondary outcomes
Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
Time frame: Baseline and Day 14
Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period
Time frame: Baseline and Day 14
Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period
Time frame: Baseline and Day 14
Change and percent change from baseline in average instantaneous ocular symptom score (iTOSS) over 14-day treatment period
Time frame: Baseline and Day 14
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of general activities on day 15
Time frame: Baseline and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Luo Zhang, Professor principal investigator
Beijing Tongren Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pumecitinib Nasal Spray 0.3%, Pumecitinib Nasal Spray 0.6% and Pumecitinib nasal spray 0.6%(twice daily) in people with Seasonal Allergic Rhinitis, run by Prime Gene Therapeutics Co., Ltd. at 20 sites 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 20 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period (time frame: Baseline and Day 14). 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 9 Sep 2026.