SinusitisPhase 2NCT06089278
A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
A Phase 2 study testing 300mg of TQH2722 injection and 600mg of TQH2722 injection in people with Sinusitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 36 sites in China.
Trial summary
To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- 300mg of TQH2722 injection and 600mg of TQH2722 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 36 sitesChina
- Study dates
- 28 Dec 2023to 30 Apr 2025
- Phase
- Phase 2
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender is not limited;
- Bilateral chronic sinusitis (with or without nasal polyps) that meets the diagnostic criteria of The Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018);
- Systemic corticosteroids (at least 1 course of prednisone 0.5 to 1 mg/kg/day or equivalent for at least 5 days) within 2 years prior to the screening, but bilateral chronic sinusitis still exist; and/or patients with drug contraindications/intolerance to systemic glucocorticoids, and (or) patients who have undergone sinus surgery within 6 months before the screening;
- Before the screening, subjects must have used a stable dose of intranasal corticosteroids (INCS) for more than 4 weeks; For participants who used INCS alternatives rather than Mometasone furoate nasal spray (MFNS) prior to screening, participants should be willing to switch to MFNS in the duration of the study;
- Subjects with asthma started inhaled glucocorticoids at a stable dose at least 4 weeks before the screening and could remain inhaled glucocorticoid doses unchanged throughout the study;
- Patients in the Run-in period should be willing to conduct diary, daily symptom assessment and maintain a stable dose of MFNS with at least 70% adherence;
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- Be able to read and understand, and be willing to sign informed consent;
- Participants and their partners agreed to use effective contraception throughout the study period (from the beginning of the screening/run-in period to 3 months after the last dose).
- Part A only：Bilateral nasal polyp score (NPS) assessed by nasal endoscopy ≥5 at both screening and randomization, with a score of ≥2 in each nostril;
- Part A only：Nasal congestion score (NCS) ≥2 at screening (daily score) and at randomization (weekly average score);
- Part A only：The following symptoms have been present continuously for at least 8 weeks prior to screening: ① nasal congestion; ② any other symptom, such as hyposmia/anosmia or rhinorrhea.
- Part B only：Prior to randomization, participants must have bilateral sinus inflammation on CT scan with a total bilateral LMK score ≥8, and bilateral ethmoid sinus opacification.
- Part B only： No nasal polyps confirmed by nasal endoscopy at Visit 1 and at randomization.
- Part B only：Subjects must have had persistent hyposmia for at least 4 consecutive weeks prior to Visit 1.
- Part B only：At screening, subjects have moderate or severe smell loss (smell loss score ≥2), and the weekly average severity ≥2 at randomization.
- Part B only：Subjects must have a sTSS (nasal congestion [NC], rhinorrhea, facial pain/pressure) ≥2 at screening (daily score) and at randomization (weekly average score).
- Part B only：Participants who have had at least one blood routine test within 2 years prior to screening, or at screening, showing blood eosinophils meeting any of the following criteria:
- Blood eosinophil count ≥0.25×10⁹/L;
- Blood eosinophil percentage ≥6.9% and the subject does not have asthma;
- Blood eosinophil percentage ≥3.7% and the subject has asthma.
Who cannot join
- Any of the following laboratory abnormalities present at screening or randomization:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × upper limit of normal (ULN);
- Total bilirubin >2 × ULN (except for indirect bilirubin elevation secondary to Gilbert's syndrome);
- Creatinine >1.5 × ULN;
- Any disease that the investigator considers unstable and may affect the patient's safety throughout the study period, or affect or interpretation with the results, or interfere with the patient's ability to complete the entire research process, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic diseases, psychiatric disorders, or major limb disorders. For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.;
- Patients with active autoimmune disease（including, but not limited to, Hashimoto's thyroiditis, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory diseases, psoriasis vulgaris, and rheumatoid arthritis）;
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- Known or suspected immunosuppression, including but not limited to a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved;
- Subjects with active malignant tumors or a history of malignant tumors; Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be enrolled in this study if at least 12 months have elapsed since the completion of curative treatment prior to Visit 1; patients with other malignant tumors may be enrolled in this study if at least 5 years have elapsed since the completion of curative treatment prior to Visit 1;
- History of active pulmonary tuberculosis within the 12 months before screening;
- Active hepatitis during the screening period, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus (HBV) DNA, or positive hepatitis C virus (HCV) antibody and positive HCV-RNA; or positive for antibodies to human immunodeficiency virus (Anti-HIV) or positive for treponemal antibodies (Anti-TP);
- Diagnosed with helminth parasitic infection within 6 months before the screening period, did not receive standard treatment or the standard treatment was ineffective;
- Subjects who have received any of the following treatments:
- Sinus surgery or sinonasal surgery within 6 months prior to screening (Visit 1);
- Treatment with monoclonal antibodies within 8 weeks or 5 half-lives prior to screening, whichever is longer, including but not limited to benralizumab, mepolizumab, omalizumab, reslizumab, dupilumab, and other drugs of the same class (IL-4R inhibitors), etc;
- Treatment with immunosuppressive agents within 8 weeks or 5 half-lives prior to screening, whichever is longer, including but not limited to cyclophosphamide, cyclosporine, interferon-γ, azathioprine, methotrexate, mycophenolate mofetil, and tacrolimus, etc;
- Use of other non-biologic investigational drugs within 8 weeks or 5 half-lives prior to screening, whichever is longer;
- Intravenous immunoglobulin (IVIG) therapy and/or plasmapheresis within 30 days prior to the screening visit (Visit 1);
- Subjects who received leukotriene antagonists/modifiers within 4 weeks prior to randomization (subjects on a stable dose of leukotriene modifiers for ≥30 consecutive days prior to randomization may be enrolled);
- Initiated allergen immunotherapy within 3 months prior to screening, or planned to initiate such treatment during the study period or to change the treatment dose during the study;
- Receipt of live attenuated vaccines within 4 weeks prior to screening, or planned receipt of live attenuated vaccines during the study period;
- Use of systemic corticosteroids within 4 weeks prior to screening;
- Within 2 weeks prior to screening or during the screening/run-in period, had a chronic active or acute infection requiring systemic treatment with antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungal agents;
- Patients with combined asthma should be excluded if they have:
- Forced expiratory volume in the first second (FEV1) ≤ 50% of normal estimates;
- Acute exacerbation of asthma within 90 days prior to screening, requiring hospitalization (>24 hours);
- used daily doses higher than 1000 mcg of fluticasone or equivalent inhaled corticosteroids (ICS);
- The subject had concomitant diseases that prevented him/her from completing the screening period assessment or from evaluating the primary efficacy endpoint:
- Deviation of the nasal septum causing complete obstruction of at least one nostril;
- Acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening;
- Persistent rhinitis medicamentosa;
- Diagnosed with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other ciliary dyskinesia syndromes, or cystic fibrosis;
- Radiologically suspected or confirmed fungal rhinosinusitis;
- Subjects with nasal malignancies and benign tumors (e.g., papillomas, hemangiomas, etc.);
- Subjects who are unable to use MFNS or who are allergic or intolerant to mometasone furoate nasal spray;
- Subjects with a history of anaphylaxis to any biological agent (other than local injection site reactions);
- Pregnant or lactating women;
- Alcoholism, drug addiction and known drug dependence;
- Have participated in clinical trials of other medical devices within 12 weeks before screening;
- The subject had poor compliance in the research and could not complete the study as judged by the investigator;
- In the judgment of the investigator or sponsoring medical reviewer, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
China36 sites
Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Beijing Hospital
Beijing, Beijing Municipality, 100005
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
Jilin Province People's Hospital
Changchun, Jilin, 130012
Loudi Central Hospital
Changsha, Hunan, 417000
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Foshan First People's Hospital
Foshan, Guangdong, 528000
The Affiliated hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Jieyang People's Hospital
Jieyang, Guangdong, 522000
Shandong Second People's Hospital
Jinan, Shandong, 250022
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Central Hospital of Shenyang Medical College
Shenyang, Liaoning, 110024
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001
Wenling First People's Hospital
Taizhou, Zhejiang, 317599
Taizhou central hospital
Taizhou, Zhejiang, 318000
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Weifang Second People's Hospital
Weifang, Shandong, 261041
Weihai Central Hospital
Weihai, Shandong, 264400
Union Hospitalc, Tongji Medical College, Huazhong, University of Science and Technology
Wuhan, Hubei, 430023
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
The Affiliated Hospital of Yanbian University
Yanji, Jilin, 133002
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zibo Central Hospital
Zibo, Shandong, 255036
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials to Assess the Effectiveness, Safety and Pharmacokinetics of TQH2722 Injection in Patients With Chronic Sinusitis With or Without Nasal Polyps.
To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps.
- Conditions
- Sinusitis
- Being tested
- 300mg of TQH2722 injection, 600mg of TQH2722 injection, TQH2722 injection matching placebo
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300mg of TQH2722 injectionDrug
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
600mg of TQH2722 injectionDrug
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection matching placeboDrug
Placebo without active substance.
| Study group | Role | What they receive |
|---|---|---|
| 300mg of TQH2722 injection | Experimental | TQH2722 injection, 14 days as a treatment cycle. Receives: Drug: 300mg of TQH2722 injection |
| 600mg of TQH2722 injection | Experimental | TQH2722 injection, 14 days as a treatment cycle. Receives: Drug: 600mg of TQH2722 injection |
| TQH2722 injection matching placebo | Placebo comparator | TQH2722 injection matching placebo, 14 days as a treatment cycle. Receives: Drug: TQH2722 injection matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nasal polyp score from baseline in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16 in part A
Changes in nasal polyp score from baseline in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16 in part A. The total score is 0-8 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in Lund-Mackay score on sinus CT scan from baseline in subjects with chronic rhinosinusitis without nasal polyps (CRSsNP) at week 16 in part B
Changes in Lund-Mackay score on sinus CT scan from baseline in subjects with chronic rhinosinusitis without nasal polyps (CRSsNP) at week 16 in part B. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Secondary outcomes (79)
Changes in sinus CT scan Lund Mackay score in Part A
Changes in sinus CT scan Lund Mackay score in subjects with chronic sinusitis without nasal polyps (CRSsNP) from baseline in Part A. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Lund-Kennedy score by nasal endoscopy in Part A
Changes in subjects' nasal endoscopy modified Lund-Kennedy score from baseline in Part A. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in Nasal Total Symptom Score (sTSS) in Part A
Changes in subjects' Nasal Total Symptom Score (sTSS) from baseline in Part A. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in 22-item Sino-Nasal Outcome Test (SNOT-22) in Part A.
Changes in 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline in Part A. The total score is 0-110 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in University of Pennsylvania Smell Identification Test (UPSIT) in Part A.
Changes in University of Pennsylvania Smell Identification Test (UPSIT) of patients from baseline in Part A. The total score is 0-40 points, with the lower score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Anosmia score in Part A.
Changes in subjects' Anosmia scores from baseline in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in nasal congestion score (NCS) in Part A.
Change in subjects' Nasal congestion Score (NCS) from baseline at week 16 in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in nasal/post-nasal discharge scores in Part A
Changes in subjects' nasal/post-nasal discharge scores from baseline at week 16 in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in facial pain/pressure scores in Part A
Changes in subjects' facial pain/pressure scores from baseline in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Visual analogue Scale (VAS) of sinusitis in Part A
Changes in the Visual Analogue Scale (VAS) for sinusitis in subjects from baseline in Part A. The total score is 0-10 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Subjects' Health-related Quality of Life (HRQoL) questionnaire in Part A
Effects of Subjects' Health-related Quality of Life (HRQoL) from baseline in Part A. The total score is 0-100 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in nasal peak inspiratory flow rate (NPIF) in Part A
Changes in the subject's nasal peak inspiratory flow rate (NPIF) from baseline in Part A
Measured: Up to 16 weeks.
Systemic glucocorticoid (SCS) remedial or surgical treatment rate in Part A
Proportion of patients receiving systemic glucocorticoid (SCS) remedial or surgical treatment during 16 weeks in Part A
Measured: Up to 16 weeks.
Incidence of adverse events in Part A
Incidence of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part A
Measured: Up to 24 weeks.
Severity of adverse events in Part A
Severity of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part A
Measured: Up to 24 weeks.
Peak concentration (Cmax) in Part A
Maximum plasma drug concentration in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Trough concentration (Cmin) in Part A
Minimum plasma drug concentration in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Peak time (Tmax) in Part A
The time required to reach peak concentration after administration in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under blood concentration-time curve (AUC0-t) in Part A
The area enclosed by the blood concentration curve to the timeline in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state peak concentration (Css-max) in Part A
The highest blood concentration that occurs in steady state in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state valley concentration (Css-min) in Part A
The lowest blood concentration that occurs in steady state in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Mean steady-state blood concentration (Css-av) in Part A
The quotient obtained by dividing the area under the blood concentration-time curve by the interval time τ during a dose interval when the blood concentration reaches a steady state in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state peak time (Tss-max) in Part A
The time required to reach peak steady-state concentration after administration in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under steady state blood concentration-time curve (AUC ss,0-t) in Part A
Area under the blood concentration-time curve in steady state in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Elimination half-life in Part A
The time it takes for half the drug to be eliminated from the body in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Apparent volume of distribution (Vd/F) in Part A
The ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Clearance rate (CL/F) in Part A
Per unit time, the volume of drug-containing liquid is completely and effectively removed by the elimination organ in Part A
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Anti-drug antibody (ADA) positive rate of subjects in Part A
Anti-drug antibody (ADA) positive rate of subjects in Part A
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Titer of Anti-drug antibody (ADA) of subjects in Part A
Titer of Anti-drug antibody (ADA) of subjects in Part A
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Incidence of subjects with neutralizing antibodies (Nab) in Part A
Incidence of subjects with neutralizing antibodies (Nab) in Part A
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Changes in University of Pennsylvania Smell Identification Test (UPSIT) in Part B.
Changes in University of Pennsylvania Smell Identification Test (UPSIT) of patients from baseline in Part B. The total score is 0-40 points, with the lower score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Anosmia score in Part B.
Changes in subjects' Anosmia scores from baseline in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Lund-Kennedy score by nasal endoscopy in Part B
Changes in subjects' nasal endoscopy modified Lund-Kennedy score from baseline in Part B. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in Nasal Total Symptom Score (sTSS) in Part B
Changes in subjects' Nasal Total Symptom Score (sTSS) from baseline in Part B. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in 22-item Sino-Nasal Outcome Test (SNOT-22) in Part B.
Changes in 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline in Part B. The total score is 0-110 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in nasal/post-nasal discharge scores in Part B
Changes in subjects' nasal/post-nasal discharge scores from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in facial pain/pressure scores in Part B
Changes in subjects' facial pain/pressure scores from baseline in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in the Visual analogue Scale (VAS) of sinusitis in Part B
Changes in the Visual Analogue Scale (VAS) for sinusitis in subjects from baseline in Part B. The total score is 0-10 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Systemic glucocorticoid (SCS) remedial or surgical treatment rate in Part B
Proportion of patients receiving systemic glucocorticoid (SCS) remedial or surgical treatment during 16 weeks in Part B.
Measured: Up to 16 weeks.
Incidence of adverse events in Part B
Incidence of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part B.
Measured: Up to 24 weeks.
Severity of adverse events in Part B
Severity of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part B.
Measured: Up to 24 weeks.
Peak concentration (Cmax) in Part B
Maximum plasma drug concentration in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Trough concentration (Cmin) in Part B
Minimum plasma drug concentration in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Peak time (Tmax) in Part B
The time required to reach peak concentration after administration in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under blood concentration-time curve (AUC0-t) in Part B
The area enclosed by the blood concentration curve to the timeline in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state peak concentration (Css-max) in Part B
The highest blood concentration that occurs in steady state in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state valley concentration (Css-min) in Part B
The lowest blood concentration that occurs in steady state in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Mean steady-state blood concentration (Css-av) in Part B
The quotient obtained by dividing the area under the blood concentration-time curve by the interval time τ during a dose interval when the blood concentration reaches a steady state in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Steady-state peak time (Tss-max) in Part B
The time required to reach peak steady-state concentration after administration in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under steady state blood concentration-time curve (AUC ss,0-t) in Part B
Area under the blood concentration-time curve in steady state in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Elimination half-life in Part B
The time it takes for half the drug to be eliminated from the body in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Apparent volume of distribution (Vd/F) in Part B
The ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Clearance rate (CL/F) in Part B
Per unit time, the volume of drug-containing liquid is completely and effectively removed by the elimination organ in Part B.
Measured: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Anti-drug antibody (ADA) positive rate of subjects in Part B
Anti-drug antibody (ADA) positive rate of subjects in Part B.
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Titer of Anti-drug antibody (ADA) of subjects in Part B
Titer of Anti-drug antibody (ADA) of subjects in Part B.
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Incidence of subjects with neutralizing antibodies (Nab) in Part B
Incidence of subjects with neutralizing antibodies (Nab) in Part B.
Measured: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Changes in Asthma Control Questionnaire (ACQ-6) score from baseline among subjects with combined asthma in part A
Change in ACQ-6 score from baseline among subjects with combined asthma in part A. The total score ranges from 0 to 6, with higher scores indicating less well-controlled asthma
Measured: Up to 16 weeks.
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in Part A
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in subjects at Week 16 in Part A.
Measured: Up to 16 weeks.
Change of Eosinophil count in peripheral blood from baseline in Part A
Change of Eosinophil count in peripheral blood from baseline in subjects in Part A.
Measured: Up to 16 weeks.
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects in Part A
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects at Week 16 in Part A.
Measured: Up to 16 weeks.
Change from baseline in Cystatin-SN (CST1) in subjects in part A
Change from baseline in Cystatin-SN (CST1) in subjects at Week 16 in part A.
Measured: Up to 16 weeks
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in Part A
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in subjects at Week 16 in Part A.
Measured: Up to 16 weeks
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in Part A
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in subjects at Week 16 in Part A
Measured: Up to 16 weeks
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part A
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part A.
Measured: Up to 16 weeks.
Change from baseline inArachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in Part A
Change from baseline in Arachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in subjects at Week 16 in Part A
Measured: Up to 16 weeks.
Change from baseline in cytokines in nasal secretions of Part A
Change from baseline in cytokines in nasal secretions in subjects at Week 16 of Part A.
Measured: Up to 16 weeks
Change from baseline in microbiota in nasal secretions of Part A
Change from baseline in microbiota in nasal secretions in subjects at Week 16 of Part A.
Measured: Up to 16 weeks.
Changes in nasal congestion score (NCS) in Part B.
Change in subjects' Nasal congestion Score (NCS) from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Measured: Up to 16 weeks.
Changes in Asthma Control Questionnaire (ACQ-6) score from baseline among subjects with combined asthma in part B
Change in ACQ-6 score from baseline among subjects with combined asthma in part B. The total score ranges from 0 to 6, with higher scores indicating less well-controlled asthma.
Measured: Up to 16 weeks.
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in Part B
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in subjects at Week 16 in Part B
Measured: Up to 16 weeks
Change of Eosinophil count in peripheral blood from baseline in Part B
Change of Eosinophil count in peripheral blood from baseline in subjects in Part A
Measured: Up to 16 weeks
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects in Part B
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects at Week 16 in Part B
Measured: Up to 16 weeks.
Change from baseline in Cystatin-SN (CST1) in subjects in part B
Change from baseline in Cystatin-SN (CST1) in subjects at Week 16 in part B
Measured: Up to 16 weeks.
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in Part B
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in subjects at Week 16 in Part B.
Measured: Up to 16 weeks.
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in Part B
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in subjects at Week 16 in Part B.
Measured: Up to 16 weeks.
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part B
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in subjects at Week 16 in Part B.
Measured: Up to 16 weeks.
Change from baseline inArachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in Part B
Change from baseline in Arachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in subjects at Week 16 in Part B.
Measured: Up to 16 weeks.
Change from baseline in cytokines in nasal secretions of Part B
Change from baseline in cytokines in nasal secretions in subjects at Week 16 of Part B.
Measured: Up to 16 weeks.
Change from baseline in microbiota in nasal secretions of Part B
Change from baseline in microbiota in nasal secretions in subjects at Week 16 of Part B.
Measured: Up to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start28 Dec 2023
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089278
- Sponsor's protocol ID
- TQH2722-II-02
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No