New injection could tame teen hay fever
NCT ID NCT07678931
First seen Jul 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests whether an injection called stapokibart can reduce nasal allergy symptoms like runny nose, congestion, sneezing, and itching in adolescents aged 12 to 17 with seasonal allergic rhinitis (hay fever). Participants receive either stapokibart or a placebo alongside their usual allergy medications. The goal is to see if the treatment improves symptom scores and quality of life over two to four weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stapokibart injection
- What this could lead to
- If effective, this could offer a new treatment option for teens with seasonal allergies that are not well controlled by standard therapies.
- What could go wrong
- This is a mid-stage trial with 136 participants, so results may not apply to everyone. The treatment may not work better than placebo, and side effects are possible.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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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12 to 18 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: * 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. Exclusion Criteria: * 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.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Seasonal allergic rhinitis (SAR) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
27 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Affiliated Hospital of Hebei University
NOT_YET_RECRUITINGBaoding, Hebei, China
Contact Email: •••••@•••••
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Baotou Central Hospital
NOT_YET_RECRUITINGBaotou, Inner Mongolia, China
Contact Email: •••••@•••••
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Beijing Children's Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
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Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
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Beijing Tongren Hospital, CMU
RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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Cangzhou Central Hospital
NOT_YET_RECRUITINGCangzhou, Hebei, China
Contact Email: •••••@•••••
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China-Japan Friendship Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
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China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, China
Contact Email: •••••@•••••
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First Affiliated Hospital of Hebei North University
NOT_YET_RECRUITINGZhangjiakou, Hebei, China
Contact Email: •••••@•••••
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Hebei General Hospital
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
Contact Email: •••••@•••••
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Hebei Petroleum Central Hospital
NOT_YET_RECRUITINGLangfang, Beijing Municipality, China
Contact Email: •••••@•••••
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Hebei Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
Contact Email: •••••@•••••
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
Contact Email: •••••@•••••
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Shandong Second Provincial General Hospital
NOT_YET_RECRUITINGJinan, Shandong, China
Contact Email: •••••@•••••
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
Contact Email: •••••@•••••
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Shengjing Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, China
Contact Email: •••••@•••••
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The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITINGHohhot, Inner Mongolia, China
Contact Email: •••••@•••••
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, China
Contact Email: •••••@•••••
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The First Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
Contact Email: •••••@•••••
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The First Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
Contact Email: •••••@•••••
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The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi’an, Shanxi, China
Contact Email: •••••@•••••
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The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
Contact Email: •••••@•••••
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Tianjin First Central Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
Contact Email: •••••@•••••
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Yantai Yuhuangding Hospital
NOT_YET_RECRUITINGYantai, Shandong, China
Contact Email: •••••@•••••
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Yinchuan First People's Hospital
NOT_YET_RECRUITINGYinchuan, Ningxia, China
Contact Email: •••••@•••••
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Zibo Central Hospital
NOT_YET_RECRUITINGZibo, Shandong, China
Contact Email: •••••@•••••
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