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

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.