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

NCT05865496 | Unknown Phase 2

• 1 other identifier: SSGJ-611-CRS-II-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Sinusitis; Nasal Polyps; Polyps

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

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

  Up to 16 weeks

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

  Up to 16 weeks

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

  Up to 16 weeks

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

  Up to 16 weeks

• 611 Concentration in Serum

  Up to 24 weeks

Study Arms (3)

611 Dose A

EXPERIMENTAL

611 300 mg Q2W, subcutaneous (SC) injection.

Drug: 611

611 Dose B

EXPERIMENTAL

611 450 mg Q4W, subcutaneous (SC) injection.

Drug: 611

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

611 DRUG

611 subcutaneous (SC) injection.

611 Dose A; 611 Dose B

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 \> 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.

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 (4)

Site 03

Beijing, Beijing Municipality, 100005, China

Location

Site 01

Beijing, Beijing Municipality, 100730, China

Location

Site 04

Wuhan, Hubei, 430022, China

Location

Site 02

Xuzhou, Jiangsu, 221004, China

Location

MeSH Terms

Conditions

Sinusitis; Nasal Polyps; Polyps

Interventions

entacapone

Condition Hierarchy (Ancestors)

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

Study Officials

• Qinghong Zhou, BS

  Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  STUDY DIRECTOR

• Luo Zhang, MD

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 25, 2023
• First Posted: May 19, 2023
• Study Start: June 30, 2023
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)