Seasonal Allergic RhinitisPhase 3PumecitinibNCT07146126
A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
A Phase 3 study testing PG-011 nasal spray 0.6%(twice daily) in people with Seasonal Allergic Rhinitis and SAR, run by Prime Gene Therapeutics Co., Ltd. at 38 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, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, SAR
- What is being tested?
- PG-011 nasal spray 0.6%(twice daily)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 38 sitesChina
- Study dates
- 15 Sep 2025to 30 Jul 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 (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 three month after after the end of the study.
- 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, upper respiratory tract infections or sinus infections within 2 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 or nasal septal perforation, 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, 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, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks, use of anti-interleukin-4 receptor α subunit (IL-4Rα) monoclonal antibody such as thymic matrix lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibody, or other biologics within 10 weeks or 5 half-lives (whichever is longer).
- 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 and have used investigational products.
- 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
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
China38 sites
The NO. 2 Hospital of Baoding
Baoding, Hebei
Yaozhong Han, +86 13070589025, 21137093@qq.com
Baotou Central Hospital
Baotou, Neimenggu
Zhendong Xu, +86 13314721473, 13314721473@163.com
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality
Xueyan Wang, +86 15301378519, Wangxueyan2018@163.com
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Luo Zhang, Professor, +86 13910830399, dr.luozhang@139.com
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Shipin Bao, +86 13901122853, baoshiping@163.com
Peking University Third Hospital
Beijing, Beijing Municipality
Yan Yan, +86 15611908358, wzyyer34@163.com
Cangzhou Central Hospital
Cangzhou, Hebei
Weiwei Liu, +86 13393275339, lwwczbj@163.com
Chifeng Municipal Hospital
Chifeng, Neimenggu
Yiqun Zhou, +86 18747661981, zhouyiqunjin@163.com
Daqing people's Hospital
Daqing, Heilongjiang
Yufen Xin, +86 13845943072, xinyufen1968@163.com
Sinopharm Tongmei General Hospital
Datong, Shanxi
Yong Gao, +86 13834121523, Tmzyyhx@163.com
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang
Haifeng Pang, +86 13895758359, phf8359@163.com
Affiliated Hospital Of Inner Mongolia Medical University
Hohhot, Neimenggu
Yanru Cui, +86 15904718063, 70757965@qq.com
Shandong Second Provincial People's Hospital
Jinan, Shandong
Li Shi, +86 17660083211, shili126@sina.com
Hebei Petro China Central Hospital
Langfang, Hebei
Jianbin Li, +86 13785658534, caoyu200211@souhu.com
Gansu Provincial people's Hospital
Lanzhou, Gansu
Hong Zhang, +86 13893654987, zhhongzl@163.com
Liaocheng People's Hospital
Liaocheng, Shandong
Yan Wang, +86 13346250188, wangyan6178@163.com
Linfen Central Hospital
Linfen, Shanxi
Lulu Zhu, +86 15135369845, 1070462593@qq.com
Linfen People's Hospital
Linfen, Shanxi
Lin Wang, +86 15698628855, WIw1II0ok@126.com
Luo Yang First People's Hospital
Luoyang, Henan
Qingrao Yuan, +86 15036722013, 597860973@qq.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Kai Xi, +86 13503794929, xikaiwj@163.com
liyujie1234@126.com
The central hospital of shenyang medical college
Shengyang, Liaoning
Gongbi Fu, +8618002478636, fugongbi@163.com
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Zhiwei Cao, +86 18940251770, caozw@sj-hospital.org
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Jun Li, +8618633022681, 4422733@qq.com
Hebei Provincial People's Hospital
Shijiazhuang, Hebei
Yongtao Qu, +86 13171807631, 35288361@qq.com
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Fuhui Huang, +86 13785658534, 13934518228@163.com
Shanxi Bethune Hospital
Taiyuan, Shanxi
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Jinmei Xue, +86 15035173166, xjment@126.com
Tonghua Central Hospital
Tonghua, Jilin
Yaowu Dong, +86 13654351900, 2657326042@qq.com
The Central Hospital of Wuhan
Wuhan, Hubei
Wei Chen, +86 15327198392, cw99990@163.com
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi
Fang Quan, +86 13572056056, quanfang2013@153.com
Xian XD Group Hospital
Xi’an, Shanxi
Jizhou Sun, +8613572973335, 35920405@qq.com
Xianyang Hospital of Yan'an University
Xianyang, Shanxi
Ligang Zhang, +86 17629106119, ligangzhang79@126.com
Yantai YuHuangDing Hospital
Yantai, Shandong
Xicheng Song, +86 18005350077, songxicheng@126.com
First People's Hospital of Yinchuan
Yinchuan, Ningxia
Ruixia Ma, +86 13909587699, s1y_gcp@163.com
People's Hospital of Ningxia Hui autonomous region
Yinchuan, Ningxia
Wei Zhou, +86 13709577181, zhw0306@126.com
Yuncheng Central Hospital
Yuncheng, Shanxi
Jun Ren, +86 18935096870, 306901253@qq.com
Zhengzhou Central Hospital, ,
Zhengzhou, Henan
Yujie Li, +86 13598068557, liyujie1234@126.com
Zibo Central Hospital
Zibo, Shandong
Daoliang Song, +86 18678186682, songdaoliang1971@163.com
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, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray 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 if PG-011 nasal spray 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 600 participants will be randomized assigned to one of the 2 following groups in a 2:1 ratio.
PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily. PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered twice daily. Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.
- Conditions
- Seasonal Allergic Rhinitis, SAR
- Being tested
- PG-011 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.
PG-011 nasal spray 0.6%(twice daily)Drug
Also called Pumecitinib nasal spray
2 sprays in each nostril, twice daily for 14-day treatment period.
PlaceboDrug
Also called Vehicle of Pumecitinib nasal spray
2 sprays in each nostril, twice daily for 14-day treatment period.
| Study group | Role | What they receive |
|---|---|---|
| PG-011 nasal spray 0.6%(twice daily) | Experimental | 2 sprays in each nostril, twice daily for 14-day treatment period. Receives: Drug: PG-011 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 |
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: Up to Day 14
Secondary outcomes (33)
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: Up to 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: Up to 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: Up to 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
rTNSS over the 14-day treatment period
This parameter evaluates the mean change in AM rTNSS from baseline over the 14-day treatment period. The AM rTNSS is a rating of the severity of nasal symptoms over the previous 12 hours and is performed in the morning.The rTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in PM participant-reported rTNSS over the 14-day treatment period
This parameter evaluates the mean change in PM rTNSS from baselineover the 14-day treatment period. The PM rTNSS is a rating of the severity of nasal symptoms over the previous 12 hours and is performed in the evening.The rTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in AM participant-reported iTNSS over the 14-day treatment period
This parameter evaluates the mean change in AM iTNSS from baselineover the 14-day treatment period. The AM iTNSS is the severity rating of the instantaneous nasal symptom at a time point. The iTNSS was calculated as the sum of the participant-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.
Measured: Up to Day 14
Mean change from baseline in PM participant-reported iTNSS over the 14-day treatment
This parameter evaluates the mean change in PM iTNSS from baselineover the 14-day treatment period.The PM iTNSS is the severity rating of the instantaneous nasal symptom at a time point. The iTNSS was calculated as the sum of the participant-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.
Measured: Up to Day 14
Mean change from baseline in AM participant-reported rTOSS over the 14-day treatment period
This parameter evaluates the mean change in AM rTOSS from baselineover the 14-day treatment period.
The AM rTOSS is a rating of the severity of ocular symptoms over the previous 12 hours and is performed in the morning.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in PM participant-reported rTOSS over the 14-day treatment period
This parameter evaluates the mean change in PM rTOSS from baselineover the 14-day treatment period.
The PM rTOSS is a rating of the severity of ocular symptoms over the previous 12 hours and is performed in the morning.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in AM participant-reported iTOSS over the 14-day treatment period
This parameter evaluates the mean change in AM iTOSS from baselineover the 14-day treatment period.
The AM iTOSS is the severity rating of the ocular symptom at a time point.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in PM participant-reported iTOSS over the 14-day treatment period
This parameter evaluates the mean change in PM iTOSS from baselineover the 14-day treatment period.
The PM iTOSS is the severity rating of the ocular symptom at a time point.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily rTNSS
This parameter evaluates the mean change in rTNSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day.The rTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily iTNSS
This parameter evaluates the mean change in iTNSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day.The iTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily rTOSS
This parameter evaluates the mean change in rTOSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily iTOSS
This parameter evaluates the mean change in iTOSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily AM rTNSS
This parameter evaluates the mean change in AM rTNSS from baseline for each day.The rTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily PM rTNSS
This parameter evaluates the mean change in PM rTNSS from baseline for each day.The rTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily AM iTNSS
This parameter evaluates the mean change in AM iTNSS from baseline for each day.The iTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily PM iTNSS
This parameter evaluates the mean change in PM iTNSS from baseline for each day.The iTNSS was calculated as the sum of the participant-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).
Measured: Up to Day 14
Mean change from baseline in the daily AM rTOSS
This parameter evaluates the mean change in AM rTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily PM rTOSS
This parameter evaluates the mean change in PM rTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily AM iTOSS
This parameter evaluates the mean change in AM iTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in the daily PM iTOSS
This parameter evaluates the mean change in PM iTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.
Measured: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of r TNSS over the 14-day treatment period
This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of rTNSS from baseline over the 14-day treatment period.
The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of AM rTNSS over the 14-day treatment period.
This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of AM rTNSS from baseline over the 14-day treatment period.
The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of PM rTNSS over the 14-day treatment period.
This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of PM rTNSS from baseline over the 14-day treatment period.
The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS over the 14-day treatment period
This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS from baseline over the 14-day treatment period.
The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of AM rTOSS over the 14-day treatment period
This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of AM rTOSS from baseline over the 14-day treatment period.
The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of PM rTOSS over the 14-day treatment period
This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of PM rTOSS from baseline over the 14-day treatment period.
The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.
Measured: Up to Day 14
Proportion and frequency of participants who use the rescue medication
The proportion of participants who use the rescue medication，and the frequency of usage during the treatment.
Measured: Up to Day 14
Mean 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: Day1, Day 8, Day 15
Safety and tolerability of PG-011 Nasal Spray
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 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
- 600 participants (estimated)
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
- NCT07146126
- Sponsor's protocol ID
- PG-011-SAR-301(phase III)
- Acronym
- Pumecitinib
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. 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
- NCT07146126
- Acronym / sponsor ID
- Pumecitinib / PG-011-SAR-301(phase III)
- Conditions
- Seasonal Allergic Rhinitis, SAR
- Keywords
- SAR, PG-011, Seasonal Allergic Rhinitis, Pumecitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 28 Aug 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, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray 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 if PG-011 nasal spray 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 600 participants will be randomized assigned to one of the 2 following groups in a 2:1 ratio.
PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily. PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered 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
- 2
| Arm | Type | Receives |
|---|---|---|
| PG-011 nasal spray 0.6%(twice daily) | Experimental | Drug: PG-011 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: Placebo2 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 three month after after the end of the study.
- 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, upper respiratory tract infections or sinus infections within 2 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 or nasal septal perforation, 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 |
|---|---|---|
| PG-011 nasal spray 0.6%(twice daily)Also: Pumecitinib nasal spray2 sprays in each nostril, twice daily for 14-day treatment period. | Drug | PG-011 nasal spray 0.6%(twice daily) |
| PlaceboAlso: Vehicle of Pumecitinib nasal spray2 sprays in each nostril, twice daily for 14-day treatment period. | Drug | Vehicle nasal spray(twice daily) |
Primary outcome
Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
Time frame: Up to 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.
33 secondary outcomes
Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
Time frame: Up to Day 14
Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period
Time frame: Up to Day 14
Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period
Time frame: Up to 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
rTNSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in PM participant-reported rTNSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in AM participant-reported iTNSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in PM participant-reported iTNSS over the 14-day treatment
Time frame: Up to Day 14
Mean change from baseline in AM participant-reported rTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in PM participant-reported rTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in AM participant-reported iTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in PM participant-reported iTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in the daily rTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily iTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily rTOSS
Time frame: Up to Day 14
Mean change from baseline in the daily iTOSS
Time frame: Up to Day 14
Mean change from baseline in the daily AM rTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily PM rTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily AM iTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily PM iTNSS
Time frame: Up to Day 14
Mean change from baseline in the daily AM rTOSS
Time frame: Up to Day 14
Mean change from baseline in the daily PM rTOSS
Time frame: Up to Day 14
Mean change from baseline in the daily AM iTOSS
Time frame: Up to Day 14
Mean change from baseline in the daily PM iTOSS
Time frame: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of r TNSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of AM rTNSS over the 14-day treatment period.
Time frame: Up to Day 14
Mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of PM rTNSS over the 14-day treatment period.
Time frame: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of AM rTOSS over the 14-day treatment period
Time frame: Up to Day 14
Mean change from baseline in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of PM rTOSS over the 14-day treatment period
Time frame: Up to Day 14
Proportion and frequency of participants who use the rescue medication
Time frame: Up to Day 14
Mean change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of general activities on day 15
Time frame: Day1, Day 8, Day 15
Safety and tolerability of PG-011 Nasal Spray
Time frame: Up to Day 21
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 28 Aug 2025.
- 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.
Luo Zhang, Professor principal investigator
Beijing Tongren Hospital
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PG-011 nasal spray 0.6%(twice daily) in people with Seasonal Allergic Rhinitis and SAR, run by Prime Gene Therapeutics Co., Ltd. at 38 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: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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 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?
Contact Luo Zhang, Professor (+86 13910830399, dr.luozhang@139.com), or a site near the patient. 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: Up to 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 28 Aug 2025.