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The Study of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GR1802 injection
placebo
Sponsored by
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline). Recorded use of intranasal corticosteroids for at least 4 weeks before screening Exclusion Criteria: Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。 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. Other.

Sites / Locations

  • Beijing Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: GR1802

Placebo Comparator: Placebo

Arm Description

GR1802 injection 300mg every two weeks for 16-week treatment

Placebo every two weeks for 16-week treatment

Outcomes

Primary Outcome Measures

Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
Change From Baseline at Week 16 in Nasal Polyp Score
NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

Secondary Outcome Measures

Time to the first response of NPS
Time to the first response of NPS (defined as bilateral endoscopic NPS improved ≥1).
Lund-Mackay score
Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse rhinosinusitis.
Bilateral endoscopic NPS
Change from baseline in the bilateral endoscopic NPS at Week 4, 8, 12, 24.
Nasal Congestion/Obstruction Symptom score(NCS)
Change from baseline in NCS at Week 4, 8, 12, 24.
University of Pennsylvania Smell Identification Test (UPSIT)
Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
Total Nasal Symptom Score(TNSS) score
Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
Visual Analogue Scale (VAS) for Rhinosinusitis
Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
Proportion of subjects receiving rescue therapy for nasal polyps
Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
Pharmacokinetics(PK)
Plasma concentration of GR1802 injection. PK parameter including trough concentration and exposure（CL/F, Vz/F etc.）
Pharmacodynamics(PD)
Change from baseline in serum biomarker level (Periostin, TARC, total IgE and eosinophil level) and biomarkers in nasal secretions and nasal exfoliated cells。
Anti-drug antibodies(ADA)
Incidence of ADA
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05873803
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: GR1802
Arm Type
Experimental
Arm Description
GR1802 injection 300mg every two weeks for 16-week treatment
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every two weeks for 16-week treatment
Intervention Type
Biological
Intervention Name(s)
GR1802 injection
Intervention Description
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
Description
Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
Time Frame
at Week 16
Title
Change From Baseline at Week 16 in Nasal Polyp Score
Description
NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Time Frame
at Week 16
Secondary Outcome Measure Information:
Title
Time to the first response of NPS
Description
Time to the first response of NPS (defined as bilateral endoscopic NPS improved ≥1).
Time Frame
Baseline up to Week 24
Title
Lund-Mackay score
Description
Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse rhinosinusitis.
Time Frame
at Week 16
Title
Bilateral endoscopic NPS
Description
Change from baseline in the bilateral endoscopic NPS at Week 4, 8, 12, 24.
Time Frame
at Week 4, 8, 12, 24
Title
Nasal Congestion/Obstruction Symptom score(NCS)
Description
Change from baseline in NCS at Week 4, 8, 12, 24.
Time Frame
at Week 4, 8, 12, 24
Title
University of Pennsylvania Smell Identification Test (UPSIT)
Description
Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
Time Frame
at Week 16
Title
Total Nasal Symptom Score(TNSS) score
Description
Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
Time Frame
at Week 16
Title
Visual Analogue Scale (VAS) for Rhinosinusitis
Description
Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
Time Frame
at Week 16
Title
Proportion of subjects receiving rescue therapy for nasal polyps
Description
Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
Time Frame
Baseline up to Week 24
Title
Pharmacokinetics(PK)
Description
Plasma concentration of GR1802 injection. PK parameter including trough concentration and exposure（CL/F, Vz/F etc.）
Time Frame
Baseline up to Week 24
Title
Pharmacodynamics(PD)
Description
Change from baseline in serum biomarker level (Periostin, TARC, total IgE and eosinophil level) and biomarkers in nasal secretions and nasal exfoliated cells。
Time Frame
at Week 16
Title
Anti-drug antibodies(ADA)
Description
Incidence of ADA
Time Frame
Baseline up to Week 24
Title
Safety parameters
Description
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline). Recorded use of intranasal corticosteroids for at least 4 weeks before screening Exclusion Criteria: Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。 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. Other.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Luo, PhD.
Phone
01065141136
Email
dr.luozhang@139.com
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Luo, PhD.
Phone
010-65141136
Email
dr.luozhang@139.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Study of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

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