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New treatment option for Seasonal Allergic Rhinitis
Official title Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT07398859
What this study is testing
What is TQH2722 injection?
TQH2722 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for seasonal allergic rhinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18-75, with no gender restrictions.
- Diagnosed with seasonal allergic rhinitis.
- Positive allergen test result.
- The people have sufficient exposure to pollen during the pollen season.
- The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen...
You likely can't join if
- Any abnormal laboratory test value during the screening period or randomization.
- Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study...
- Patients with active autoimmune diseases.
- Known or suspected immunosuppressants.
- people with active malignant tumors or a history of malignant tumors.
- Screen for individuals with a history of active tuberculosis within the previous 12 months.
See the full eligibility criteria
- Aged 18-75, with no gender restrictions.
- Diagnosed with seasonal allergic rhinitis.
- Positive allergen test result.
- The people have sufficient exposure to pollen during the pollen season.
- The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom...
- Screen for people who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.
- Good compliance during screening/induction period.
- people with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.
- The people voluntarily joined this study, signed the informed consent form, and exhibited good compliance.
- The people and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial...
- Any abnormal laboratory test value during the screening period or randomization.
- Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to...
- Patients with active autoimmune diseases.
- Known or suspected immunosuppressants.
- people with active malignant tumors or a history of malignant tumors.
- Screen for individuals with a history of active tuberculosis within the previous 12 months.
- During the screening period, there is active hepatitis, or the presence of human immunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponema antibody (Anti-TP) positivity.
- Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffective standard treatment.
- people who have received specific medications or undergone any nasal or sinus surgery within the specified timeframe.
- Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days before screening.
- Screen people who have used monoamine oxidase inhibitors within the previous 14 days.
- Initiate allergen immunotherapy within 3 months prior to screening.
- Screen for individuals who have received attenuated live vaccines within the previous 4 weeks or plan to receive attenuated live vaccines during the study period.
- Screen for systemic Chinese herbal preparations used for the treatment of AR with short- or medium-acting systemic glucocorticoids within 4 weeks, or screen for long-acting Systemic Corticosteroids (SCS) received within...
- Suffering from chronic active or acute infection within 2 weeks before screening or during the screening and import period.
- Patients with concomitant asthma should be excluded if they meet any of the following conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of the predicted normal value; b. acute exacerbation of asthma...
- The subject has a concomitant disease that renders them unable to complete the screening period assessment or evaluate the primary how well it works endpoint.
- Suffering from malignant and benign tumors in the nasal cavity.
- people with perennial allergic rhinitis (PAR) who are allergic to pet hair.
- Unable to use nasal corticosteroid sprays or antihistamines.
- Have a history of systemic allergy to any biological agents.
- Women who are pregnant or breastfeeding.
- Individuals who abuse alcohol, use drugs, and have known drug dependency.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- According to the researcher's judgment, there are any medical or psychiatric symptoms that may put the people at risk, interfere with their participation in the study, or interfere with the interpretation of the study...
- The forced expiratory volume in one second (FEV1) of the subject is less than or equal to 50% of the predicted normal value.
- Other reasons why the researcher believes it is inappropriate to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Baoding, Hebei, China
- Cangzhou, Hebei, China
- Langfang, Hebei, China
- Shijiazhuang, Hebei, China
- Zhangjiakou, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Xi'an, Shaanxi, China
- Jinan, Shandong, China
- Yantai, Shandong, China
- Zibo, Shandong, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Baoding, Hebei, China; Cangzhou, Hebei, China; Langfang, Hebei, China; Shijiazhuang, Hebei, China and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.