Seasonal Allergic Rhinitis (SAR)Phase 3NCT07678931
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
A Phase 3 study testing Stapokibart in people with Seasonal Allergic Rhinitis (SAR), run by Chengdu Kangnuoxing Biopharma,Inc. at 27 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of stapokibart in adolescent patients with seasonal allergic rhinitis, and observing the quality of life, Pharmakokinetics(PK), Pharmacodynamics (PD) characteristics, and… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Seasonal Allergic Rhinitis (SAR)
- What is being tested?
- Stapokibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 27 sitesChina
- Study dates
- 13 Aug 2026to Dec 2026
- Phase
- Phase 3
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range: ≥12 years to <18 years
- Voluntarily sign the informed consent form.
- Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
- Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- Weight≥40kg.
- Symptom severity scores for the season met the enrollment criteria.
Who cannot join
- Subjects who received anti-interleukin-4 receptor alpha(anti-IL-4Rα), anti-thymic stromal lymphopoietin(anti-TSLP), anti-immunoglobulin E(anti-IgE) monoclonal antibodies or other biologics within 10 weeks or 5 half-lives prior to screening (whichever is longer), or have a history of inadequate therapeutic response or intolerance to prior anti-IL-4Rα monoclonal antibody treatment for seasonal allergic rhinitis.
- Subjects with known hypersensitivity to stapokibart, any anti-IL-4Rα monoclonal antibody, or any ingredients of background concomitant medications.
- Subjects who newly initiate allergen-specific immunotherapy within 3 months before screening or intend to receive such therapy during the trial, or whose allergen exposure at home or workplace is expected to change significantly throughout the study period.
- Subjects with poorly controlled recent asthma or concomitant severe asthma with percent predicted Forced Expiratory Volume in one second(FEV1) ≤50% at screening.
- Subjects presenting other active nasal comorbidities at screening (chronic rhinitis, drug-induced rhinitis, chronic rhinosinusitis with or without nasal polyps, severe nasal septal deviation, etc.) that may interfere with efficacy determination.
- Subjects with current or past history of infections of special concern (active tuberculosis, helminthic infections, severe herpes virus infections, etc.), or diagnosed with malignant tumors within 5 years before screening, excluding fully cured cervical carcinoma in situ and non-metastatic cutaneous squamous or basal cell carcinoma.
- Subjects with severe underlying medical conditions including severe hepatic and renal impairment, autoimmune diseases, cardiovascular and cerebrovascular disorders, HIV infection, active hepatitis B/C, immunosuppression, or history of solid organ/hematopoietic stem cell transplantation which, in the investigator's opinion, may pose safety risks via trial participation.
- Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei
Congzhe Tian, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Zhendong Xu, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality
Pengpeng Wang, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Yuhe Liu, 028-88610620, clinicaltrial@keymedbio.com
- Recruiting
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality
Luo Zhang, 028-88610620, clinicaltrial@keymedbio.com
chengshuo wang, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Jianfeng Liu, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality
Kai Guan, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Yan Yan, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Weiwei Liu, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Dongdong Zhu, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Xiaobo Cui, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Shandong Second Provincial General Hospital
Jinan, Shandong
Li Shi, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Hebei Petroleum Central Hospital
Langfang, Beijing Municipality
Jianbin Li, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Zhiwei Cao, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Yongtao Qu, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Jun Li, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Yupeng Shen, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Huanping Zhang, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Yan Feng, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Jinmei Xue, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Wei Wang, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Xiaoyong Ren, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Xicheng Song, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Yinchuan First People's Hospital
Yinchuan, Ningxia
Ruixia Ma, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
Xiaoling Shang, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Dong Dong, 028-88610620, clinicaltrial@keymedbio.com
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong
Daoliang Song, 028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Adolescent Patients With Seasonal Allergic Rhinitis Receiving Background Therapy
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of stapokibart in adolescent patients with seasonal allergic rhinitis, and observing the quality of life, Pharmakokinetics(PK), Pharmacodynamics (PD) characteristics, and immunogenicity of subjects.
Read the detailed description
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
All participants will receive standard of care treatment as concomitant medications. Stapokibart or placebo will be administered as add-on therapy.
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Being tested
- Stapokibart, 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.
StapokibartBiological
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart group | Experimental | Not described Receives: Biological: Stapokibart |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Secondary outcomes (18)
Mean change from baseline in daily rTNSS over 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change and mean percent change from baseline in daily AM pre-dose instantaneous total nasal symptom score (iTNSS) over 2 weeks and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change from baseline in daily rTNSS (including AM rTNSS and PM rTNSS) for individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 2 and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change and mean percent change from baseline in daily reflective total ocular symptom score (rTOSS) over 2 weeks or 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change from baseline in daily AM and PM reflective total ocular symptom score (AM and PM rTOSS) over 2 weeks and 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Mean change from baseline in daily rTOSS (including AM and PM rTOSS) for individual symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) over 2 weeks and 4 weeks of treatment
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.With higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ(S)≥12) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week.Each question is scored from 0 to 6, with higher scores indicating a greater impact on quality of life.
Measured: Up to week 4
Incidence of adverse events (AEs)
Evaluate the incidence of treatment-emergency adverse events.
Measured: Up to week 12
Serum Stapokibart concentration
Collect the blood samples for Pharmacokinetics analysis
Measured: Up to week 12
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE)
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
change and percent change from baseline of counts and ratios of eosinophil in blood
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Collect the blood samples for anti-drug antibody testing
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start13 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 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 Rhinitis (SAR)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren Hospital Affiliated to Capital Medical UniversityChengshuo Wang, Principal investigator, Beijing Tongren Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678931
- Sponsor's protocol ID
- CM310-107208
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No