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New treatment option for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Official title Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
ClinicalTrials.gov ID: NCT07107256
What this study is testing
What is TQC2731 injection?
TQC2731 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic rhinosinusitis with nasal polyps (crswnp).
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
- TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Phase 3: a large, late-stage study
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
- Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse...
- Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis...
- At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years...
- Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization.
You likely can't join if
- Conditions/Diseases Affecting how well it works Evaluation
- Nasal septum deviation causing ≥1 nostril obstruction；
- Perforation of the nasal septum
- Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods；
- Rhinitis medicamentosa；
- Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other ciliary...
See the full eligibility criteria
Who can join
- Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions.
- Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)"
- At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND/OR...
- Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization.
- Nasal Congestion Score (NCS) ≥2 at screening (daily average) and randomization (weekly average).
- Persistent symptoms of rhinorrhea and/or hyposmia/anosmia for over 8 weeks prior to screening.
- 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and randomization.
- Stable dose of intranasal corticosteroids (INCS) for \>4 weeks prior to screening (people using non-mometasone furoate nasal spray [MFNS] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the...
- people with comorbid asthma must have had stable asthma symptoms for ≥4 weeks prior to screening (if using medications, such as inhaled corticosteroids, the same dose must have been stably maintained for ≥4 weeks before...
- The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%, and the adherence to daily symptom assessment records in the...
- Agreement to practice effective non-pharmacologic contraception from informed consent until 6 months post-final dose, for people/partners of childbearing potential.
What rules you out
- Conditions/Diseases Affecting how well it works Evaluation
- Nasal septum deviation causing ≥1 nostril obstruction；
- Perforation of the nasal septum
- Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods；
- Rhinitis medicamentosa；
- Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other ciliary dyskinesia syndromes, or cystic fibrosis；
- Suspected or confirmed fungal sinusitis by imaging；
- Prior nasal surgery altering lateral wall structure precluding NPS assessment；
- Nasal malignancies or benign tumors (e.g., papilloma, hemangioma)；
- Any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to screening.
- Uncontrolled epistaxis within 2 months prior to screening.
- Regular use of decongestants (topical or systemic) prior to screening, except for short-term use during endoscopic examinations.
- Patients who have received any of the following treatments prior to randomization:
- Treatment with immunosuppressants (including but not limited to: cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate, tacrolimus, Secukinumab) within 8 weeks or 5 half-lives prior...
- Treatment with any monoclonal antibodies (including but not limited to: benralizumab, mepolizumab, omalizumab, dupilumab, or other similar drugs [e.g., TSLP blockers]) within 8 weeks or 5 half-lives prior to screening...
- Patients who used medium- or short-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular administration), systemic traditional Chinese medicine preparations for treating CRS within 4 weeks...
- Use of corticosteroid-eluting nasal stents within 6 months prior to screening;
- Treatment with immunoglobulins or blood products within 28 days prior to screening;
- Administration of live attenuated vaccines within 28 days prior to screening or planned during the study period;
- Allergen-specific immunotherapy within 6 months prior to screening (allowed only if: initiated \>3 months before screening, maintained at a stable dose for ≥1 month before Visit 1, and no planned dose changes during the...
- Participation in other drug/medical device clinical trials within 3 months prior to screening (based on last administration/use).
- Use nasal antihistamines (such as olopatadine nasal spray, azelastine nasal spray, levocabastine nasal spray, etc.) for the first 3 days.
- Screening for a history of active pulmonary tuberculosis within the past 12 months；
- Exclusion of infections within the last 14 days requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal therapy;
- Exclusion of people diagnosed with helminthic parasitic infection in the past 6 months who either did not receive standard treatment or had treatment failure；
- Known or suspected history of immunosuppression, immune dysfunction, or immune dysregulation, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis...
- The forced expiratory volume in the first second (FEV1) of the people during the screening/introduction period was ≤ 50% of the normal predicted value.
- Patients with comorbid asthma who meet any of the following criteria: Asthma exacerbation within 90 days before screening, or current use of inhaled corticosteroids (ICS) at a daily dose higher than 1000μg fluticasone...
- Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline OCS) for at least 3 consecutive days due to worsening asthma; a single injection of depot long-acting corticosteroids may be...
- An emergency department or urgent care center visit due to asthma requiring systemic corticosteroids (as described above) (defined as evaluation and treatment in the emergency department or urgent care center lasting...
- Hospitalization due to asthma (defined as admission to a medical facility and/or evaluation and treatment in a healthcare setting lasting ≥24 hours).
- Use of leukotriene antagonists/modulators prior to randomization (people who have been on a stable dose of leukotriene modulators for ≥30 days continuously prior to randomization may be enrolled);
- Presence of other concurrent active or clinically significant respiratory diseases that, in the investigator's judgment, may significantly impact the study, such as active tuberculosis, lung cancer, bronchiectasis...
- people who have undergone lobectomy or lung volume reduction surgery within 12 months prior to the start of the study;
- Exclusion of people with cardiovascular conditions (including but not limited to unstable ischemic heart disease, heart failure, uncontrolled hypertension, myocardial infarction, significant arrhythmias, long QT...
- Exclude individuals with difficult venous access or a history of vasovagal syncope (needle/blood-related);
- Exclusion of any current active malignancy or history of malignancy (Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible if curative...
- Presence of active autoimmune diseases (including but not limited to Hashimoto's thyroiditis with hyperthyroidism, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus...
- Exclusion if any infectious disease screening indicator meets the following criteria during screening;
- Exclusion of people who are positive for hepatitis B virus surface antigen (HBsAg).
- Hepatitis B virus core antibody (HBcAb) with detectable Hepatitis B Virus (HBV)-DNA.
- Exclude if Hepatitis C Virus (HCV) antibody-positive and HCV-RNA positive, or if previously treated for HCV (regardless of current HCV-RNA status).
- Anti-Treponema pallidum antibody (Anti-TP) positive (if syphilis serology is positive, a non-treponemal test must be performed; people with a negative non-treponemal test and deemed by the investigator as previously...
- Anti-HIV positive
- Abnormal laboratory test results:
- White blood cell count \<3.5 × 10⁹/L;
- Aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) \>2.5 × ULN;
- Total bilirubin \>2 × ULN;
- Creatinine \>1.5 × ULN
- Any clinically significant abnormal findings during the import period, including physical examination, vital signs, 12-lead ECG, blood biochemistry, hematology, or urinalysis, which in the investigator's judgment may...
- Women who are pregnant or lactating.
- Those who were still smokers or had quit smoking for less than six months at the time of screening.
- Exclude those with regular excessive alcohol consumption (\>14 units/week for females or \>21 units/week for males) in the past 6 months, inability to abstain during the trial, or a positive breath alcohol test.
- History of drug abuse within the past 2 years, or a positive drug abuse screening result.
- people with a known history of hypersensitivity or allergic reaction to any ingredient of mometasone furoate nasal spray (Nasonex®) or TQC2731 injection.
- Exclusion for any history of systemic allergic reaction to biologic agents (local injection site reactions excluded).
- The participant demonstrated poor adherence and was deemed unable to complete the study.
- Any medical or psychiatric condition that, in the judgment of the investigator or the sponsor's medical reviewer, may affect the subject's safety throughout the study or impede the subject's ability to complete the...
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
- Cangzhou, Hebei, China
- Langfang, Hebei, China
- Shijiazhuang, Hebei, China
- Zhangjiakou, Hebei, China
- Daqing, Heilongjiang, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Wuhan, Hubei, China
- Changde, Hunan, China
- Changsha, Hunan, China
- Chifeng, Inner Mongolia, China
+ 30 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Fuyang, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China and 44 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.