A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.16 sites in 1 country80 target enrollmentDecember 8, 2023

ConditionsChronic Sinusitis Nasal Polyps

InterventionsTQC2731 injection TQC2731 matching placebo

DrugsTQC2731 injection TQC2731 matching placebo

Overview

Phase: Phase 2
Intervention: TQC2731 injection
Conditions: Chronic Sinusitis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 80
Locations: 16
Primary Endpoint: Nasal Polyp Score (NPS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy, safety and pharmacokinetics of TQC2731 injection in the treatment of Chronic Sinusitis with Nasal Polyps.

Registry

clinicaltrials.gov

Start Date

December 8, 2023

End Date

March 27, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects sign informed consent before study, fully understand the purpose, procedures and possible adverse reactions of the study;
•Male and female, ≥18 years old and ≤ 75 years old;
•Bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) who met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of chronic rhinosinusitis (2018);
•Received nasal polyp surgery or received systemic glucocorticoid treatment 2 years before screening;
•Bilateral nasal polyp score (NPS) ≥5 and each nostril was scored ≥ 2 when screening and randomization;
•Nasal congestion score (NCS) ≥2 when screening and randomization;
•Persistent nasal leakage or smell decrease or loss last more than 8 weeks before screening;
•Sinonasal outcome testing 22 (SNOT-22) score ≥ 30 when screening and randomization;
•Subjects received steady dose of intranasal glucocorticoids (INCS) over 4 weeks before screening (subjects agree use Mometasone Furoate Aqueous Nasal Spray (MFNS) while studying);
•Subjects with asthma start inhaled stable dose of glucocorticoid therapy over 4 weeks before screening, and are willing to keep the dose during whole study;

Exclusion Criteria

•Presence of conditions/concomitant diseases that affect the evaluation of efficacy, such as:
•Posterior nostril polyps;
•Deviation of the nasal septum resulted in obstruction of at least one nostril;
•Acute sinusitis, nasal infection, or upper respiratory tract infection had occurred 2 weeks before screening, screening period or mediation period;
•Drug induced rhinitis;
•Allergic granulomatous vasculitis (Churg-Strauss syndrome), granuloma with poly vasculitis (Wegener's granuloma), Young syndrome, Kartagener syndrome, or other dysphoric ciliary syndrome, with cystic fibrosis;
•Imaging suspected or confirmed fungal sinusitis;
•NPS cannot be evaluated due to nasal surgery to alter the structure of the lateral nasal wall;
•Subjects with nasal malignancies and benign tumors (papilloma, blood furuncle, etc.)
•Any type of active malignancy or a history of malignancy (Patient with basal cell carcinoma, skin localized squamous cell carcinoma or carcinoma in situ of cervix, can participate in the study if curative treatment was completed for more than 12 months prior to visit 1; Patients with other malignant tumors can participate in the study if curative therapy had been completed for at least 5 years prior to visit 1);

Arms & Interventions

TQC2731 injection 210 mg

TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Intervention: TQC2731 injection

TQC2731 injection 420 mg

TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Intervention: TQC2731 injection

TQC2731 matching placebo

TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Intervention: TQC2731 matching placebo

Outcomes

Primary Outcomes

Nasal Polyp Score (NPS)

Time Frame: Baseline up to 24 weeks

NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.

Secondary Outcomes

Anosmia Score(Baseline up to 24 weeks)
Total symptom score (TSS)(Baseline up to 24 weeks)
Incidence of Adverse event (AE)(Baseline up to 32 weeks)
Severity of AE(Baseline up to 32 weeks)
Peak concentration (Cmax)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Trough concentration (Cmin)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Time to Peak concentration (Tmax)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Area under the concentration time curve (AUC0-t)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Maximum plasma concentration at steady state (Css-max)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Minimum plasma concentration at steady state (Css-min)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Plasma concentration at steady state (Css-av)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Nasal congestion score (NCS)(Baseline up to 24 weeks)
Visual analogue scale (VAS) for sinusitis(Baseline up to 24 weeks)
Nasal polyp (NP) surgery time(Baseline up to 32 weeks)
Nasal polyp (NP) surgery ratio(Baseline up to 32 weeks)
Time of Systemic glucocorticoids (SCS) remedial treatment(Baseline up to 32 weeks)
Ratio of Systemic glucocorticoids (SCS) treatment(Baseline up to 32 weeks)
Lund Mackay (LMK) score(Baseline up to 24 weeks)
Time to Peak concentration at steady state (Tss-max)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Area under the concentration time curve (AUC0-t) at steady state(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Half life (t1/2)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Apparent volume distribution (Vd/F)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Plasma clearance (CL/F)(Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.)
Anti-drug antibody (ADA)(Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal)
Neutralizing antibody (Nab)(Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal)