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Tests treatment safety and results for Chronic Rhinosinusitis
Official title Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps
ClinicalTrials.gov ID: NCT06439381
What this study is testing
What is 300mg/600mg of TQH2722 injection?
300mg/600mg of TQH2722 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic rhinosinusitis.
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 is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- of Part A
- Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
- Age 18-75 years old (including the threshold), male or female;
- Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following...
- people completed prescribed treatment as required and completed Part A end of study (EOS) visit;
You likely can't join if
- In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after...
- The people had poor compliance in the main study, and the researchers judged that they could not complete the continuing study.
- During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring...
- Any of the following laboratory test values are abnormal during the screening period:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN);
- Total bilirubin \> 2 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome);
See the full eligibility criteria
Who can join
- of Part A
- Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
- Age 18-75 years old (including the threshold), male or female;
- Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
- people completed prescribed treatment as required and completed Part A end of study (EOS) visit;
- The people withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the...
- people had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for people who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS)...
- people agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age.
- of Part B
- Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
- Age 18-75 years old (including the threshold), male or female;
- Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
- people completed prescribed treatment as required and completed Part B EOS visit;
- The people withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the...
- people had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for people who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS)...
- people agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age.
What rules you out
- In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after discussion between the investigator and sponsor, the subject was deemed...
- The people had poor compliance in the main study, and the researchers judged that they could not complete the continuing study.
- During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring adjustment of background medication) is identified and the subject is deemed...
- Any of the following laboratory test values are abnormal during the screening period:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN);
- Total bilirubin \> 2 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome);
- Creatinine \> 1.5×ULN;
- Any medical condition, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major limb disorders...
- Patients with active autoimmune diseases (including, but not limited to, Hashimoto thyroiditis, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis...
- Known or suspected immunosuppressed individuals, including but not limited to a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cyst disease...
- people with active malignant tumors or a history of malignant tumors:Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ who had completed curative treatment for at...
- A history of active pulmonary tuberculosis within 12 months prior to screening;
- Active hepatitis was present at the screening stage, either hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and Hepatitis B Virus-DNA positive, or Hepatitis C Virus (HCV)...
- Diagnosis of helminthic infection within 6 months prior to the screening period, failure to receive standard treatment or failure to respond to standard treatment;
- people who received the following treatments:
- Had sinus surgery or nasal sinus surgery within 6 months prior to screening (visit 1).
- Received monoclonal antibody therapy within 8 weeks or 5 half-lives prior to screening (whichever is longer);
- Received immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate and tacrolimus) within 8 weeks or 5 half-lives prior to...
- Use of other non-biological agents within 8 weeks or 5 half-lives (whichever is longer) prior to screening;
- Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days prior to screening visit (Visit 1);
- people treated with leukotriene antagonists/modulators prior to screening (people treated with stable doses of leukotriene modulators for ≥30 days prior to screening can be enrolled);
- Start allergen immunotherapy within 3 months prior to screening, or plan to start such therapy during the study period or plan to change the therapeutic dose during the study period;
- Have received live attenuated vaccine within 4 weeks prior to screening or plan to receive live attenuated vaccine during the study period;
- Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasites, antivirals, or antifungals during the 4 weeks prior to screening, or a viral disease that may not have received...
- Patients with asthma should be excluded if: a. forced expiratory volume in the first second (FEV1) ≤ 50% of the expected normal value, or b.Acute exacerbation of asthma within 90 days prior to screening requiring...
- people with asthma were initiated with inhaled corticosteroids within 4 weeks prior to the screening/induction period (for people who could receive a stable dose for at least 4 weeks prior to screening and whose...
- people have concomitant medical conditions that prevent them from completing the screening period assessment or evaluating the primary how well it works endpoint, such as:
- A deviated nasal septum leads to obstruction of at least one nostril
- Persistent drug rhinitis;
- The diagnosis was eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), granulomatous polyvasculitis (Wegener's granuloma), Young's syndrome, Kartagener syndrome or other ciliary dyskinesia syndrome, cystic...
- Suspected or confirmed fungal rhinosinusitis on imaging;
- people with nasal malignancies and benign tumors (e.g., papilloma, hemangioma, etc.);
- people who are unable to use MFNS or are allergic or intolerant to Mometasone furoate nasal spray;
- people with a history of systemic allergy to any biological agent (except local injection site reactions);
- Pregnant or lactating women;
- Alcohol, drug and known drug dependence;
- The people had poor compliance in the study and could not complete the study as judged by the researcher;
- Any medical or psychiatric condition that, in the judgment of the investigator or sponsor medical reviewer, puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Foshan, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Cangzhou, Heibei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Baotou, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Yanji, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Weihai, Shandong, China
- Yantai, Shandong, China
- Zibo, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shangxi, China
+ 4 more site(s).
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; Foshan, Guangdong, China; Shenzhen, Guangdong, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Cangzhou, Heibei, China and 18 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.