A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Sinusitis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05865496
• Other study ID #: SSGJ-611-CRS-II-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female and male patients aged =18 and = 75 years at the time of screening.

2. Bilateral CRSwNP.

3. Bilateral NPS of =5 with a minimum score of 2 in each nasal cavity

4. Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization.

5. 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:

1. Patients with other nasal diseases or symptoms.

2. 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.

3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.

4. History of cancer.

5. Known or suspected history of immunosuppression.

6. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• 611
611 subcutaneous (SC) injection.
• Placebo
Placebo subcutaneous (SC) injection.

Locations

Country	Name	City	State
China	Site 01	Beijing	Beijing
China	Site 03	Beijing	Beijing
China	Site 04	Wuhan	Hubei
China	Site 02	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 16 weeks
Primary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	611 Concentration in Serum	The concentration of 611 in Serum.	Up to 24 weeks