Back to resultsA Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Primary Purpose
Sinusitis, Nasal Polyps, Polyps
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
611
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis
Eligibility Criteria
Inclusion Criteria: Female and male patients aged ≥18 and ≤ 75 years at the time of screening. Bilateral CRSwNP. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization. Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF. Exclusion Criteria: Patients with other nasal diseases or symptoms. Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. History of cancer. Known or suspected history of immunosuppression. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
Sites / Locations
- Site 03
- Site 01
- Site 04
- Site 02
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
611 Dose A
611 Dose B
Placebo
Arm Description
611 300 mg Q2W, subcutaneous (SC) injection.
611 450 mg Q4W, subcutaneous (SC) injection.
Placebo subcutaneous (SC) injection.
Outcomes
Primary Outcome Measures
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease.
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
Secondary Outcome Measures
Change From Baseline to the End of study in Lund Mackay Score
The Lund Mackay Score scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease.
Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
TNSS is a composite of nasal congestion, loss of smell, and rhinorrhea (anterior/posterior nasal discharge), each access on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranges from 0 (no symptoms) to 12 (severe symptoms). Higher score indicated more severe symptoms.
Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT is a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss.
Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
The SNOT-22 is a validated questionnaire that used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
611 Concentration in Serum
The concentration of 611 in Serum.
Full Information
NCT ID
NCT05865496
First Posted
April 25, 2023
Last Updated
May 15, 2023
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05865496
Brief Title
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Detailed Description
The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Nasal Polyps, Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
611 Dose A
Arm Type
Experimental
Arm Description
611 300 mg Q2W, subcutaneous (SC) injection.
Arm Title
611 Dose B
Arm Type
Experimental
Arm Description
611 450 mg Q4W, subcutaneous (SC) injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
611
Intervention Description
611 subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous (SC) injection.
Primary Outcome Measure Information:
Title
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
Description
NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease.
Time Frame
Up to 16 weeks
Title
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
Description
NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to the End of study in Lund Mackay Score
Description
The Lund Mackay Score scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease.
Time Frame
Up to 16 weeks
Title
Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
Description
TNSS is a composite of nasal congestion, loss of smell, and rhinorrhea (anterior/posterior nasal discharge), each access on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranges from 0 (no symptoms) to 12 (severe symptoms). Higher score indicated more severe symptoms.
Time Frame
Up to 16 weeks
Title
Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
Description
The UPSIT is a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss.
Time Frame
Up to 16 weeks
Title
Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
Description
The SNOT-22 is a validated questionnaire that used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
Time Frame
Up to 16 weeks
Title
611 Concentration in Serum
Description
The concentration of 611 in Serum.
Time Frame
Up to 24 weeks
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:
Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
Bilateral CRSwNP.
Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization.
Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
Exclusion Criteria:
Patients with other nasal diseases or symptoms.
Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
History of cancer.
Known or suspected history of immunosuppression.
Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghong Zhou, BS
Phone
+86 18911301578
Email
zhouqinghong@3sbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghong Zhou, BS
Organizational Affiliation
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luo Zhang, MD
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 03
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD
Facility Name
Site 01
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Zhang, MD
Facility Name
Site 04
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Chen, MD
Facility Name
Site 02
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Liu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
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