Can a new nasal spray tame seasonal allergy misery?
NCT ID NCT06837233
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing a nasal spray called PG-011 in adults with moderate to severe seasonal allergic rhinitis. The trial compares two strengths and dosing schedules of the spray against a placebo to see which might best reduce nasal symptoms like runny nose, sneezing, congestion, and itching. About 179 adults aged 18 to 65 with a history of seasonal allergies take part, using the spray for 14 days while tracking their symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pumecitinib nasal spray
- What this could lead to
- If it works, this could offer a new nasal spray option to calm runny nose, sneezing, congestion, and itching during allergy season.
- What could go wrong
- This is an early-phase dose-finding study, so the spray may not outperform a placebo or may cause nasal irritation. Larger trials would still be needed to confirm any benefit.
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
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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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179 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Jun 2025
- 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. Male or female aged 18 to 65 (including threshold). 2. 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 3. 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). 4. 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. 5. Willing to sign the informed consent form and abide by the research protocol. Exclusion Criteria: 1. Participants are diagnosed of active or latent tuberculosis infection. 2. Participants are diagnosed of moderate to severe asthma. 3. 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. 4. Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed. 5. 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. 6. Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis). 7. 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. 8. 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 . 9. 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. 10. 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. 11. 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. 12. Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening. 13. 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. 14. Participants who have a history of intolerance to intranasal administration. 15. Participants who plan to travel outside the local area for 2 consecutive days or more during the trial. 16. Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening. 17. Participants who have a history of drug abuse or alcoholism within 1 year prior to screening 18. Female participants who are breastfeeding or pregnant at the time of screening 19. 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 20. Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in 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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Baotou Central Hospital
Baotou, Neimenggu, China
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Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Cangzhou Central Hospital
Cangzhou, Hebei, China
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Chifeng Municipal Hospital
Chifeng, Neimenggu, China
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First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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Hebei Petro China Central Hospital
Langfang, Hebei, China
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Liaocheng People's Hospital
Liaocheng, Shandong, China
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Linfen Central Hospital
Linfen, Shanxi, China
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Linfen People's Hospital
Linfen, Shanxi, China
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Luo Yang First People's Hospital
Luoyang, Henan, China
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Shandong Second Provincial People's Hospital
Jinan, Shandong, China
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
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The Central Hospital of Wuhan
Wuhan, Hubei, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
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Yantai YuHuangDing Hospital
Yantai, Shandong, China
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Yuncheng Central Hospital
Yuncheng, Shanxi, China
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Zhengzhou Central Hospital
Zhengzhou, Henan, China
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Zibo Central Hospital
Zibo, Shandong, China
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Other studies related to the condition(s) this trial covers.
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- New allergy pill could offer relief from sneezing and stuffy nose
- New injection could tame seasonal allergy symptoms for those failed by standard treatments
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- Nasal spray test could make allergy shots smarter and cheaper