Clinical trial NCT05873803: The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps
Official title: A Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety of GR1802 Injection in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis with Nasal Polyps
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks).

70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.

Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility criteria: Inclusion Criteria:

1. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps
2. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
3. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).
4. Recorded use of intranasal corticosteroids for at least 4 weeks before screening

Exclusion Criteria:

1. Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。
2. Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.
3. Other.

Primary outcomes:
measure: Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
timeFrame: at Week 16
measure: Change From Baseline at Week 16 in Nasal Polyp Score
timeFrame: at Week 16
Secondary outcomes:
measure: Time to the first response of NPS
timeFrame: Baseline up to Week 24
measure: Lund-Mackay score
timeFrame: at Week 16
measure: Bilateral endoscopic NPS
timeFrame: at Week 4, 8, 12, 24
measure: Nasal Congestion/Obstruction Symptom score(NCS)
timeFrame: at Week 4, 8, 12, 24
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: at Week 16
measure: Total Nasal Symptom Score(TNSS) score
timeFrame: at Week 16
measure: Visual Analogue Scale (VAS) for Rhinosinusitis
timeFrame: at Week 16
measure: Proportion of subjects receiving rescue therapy for nasal polyps
timeFrame: Baseline up to Week 24
measure: Pharmacokinetics(PK)
timeFrame: Baseline up to Week 24
measure: Pharmacodynamics(PD)
timeFrame: at Week 16
measure: Anti-drug antibodies(ADA)
timeFrame: Baseline up to Week 24
measure: Safety parameters
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: