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

NCT06639295 | Active Not Recruiting Phase 3

• 1 other identifier: SSGJ-611-CRS-III-01
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Polyps; Sinusitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at Week 24 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

  24 weeks

• Change From Baseline at Week 24 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.

  24 weeks

Secondary Outcomes (6)

• Change From Baseline to the End of study in Lund Mackay Score

  through study completion, an average of 13 months

• Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)

  through study completion, an average of 13 months

• Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score

  through study completion, an average of 13 months

• Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores

  through study completion, an average of 13 months

• Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.

  through study completion, an average of 13 months

Study Arms (2)

611

EXPERIMENTAL

611 2ml Q2W, subcutaneous (SC) injection

Drug: 611

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

611 DRUG

611 subcutaneous (SC) injection.

611

Placebo DRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Site 01

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Interventions

entacapone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 22, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)