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NCT05865496 | ACTIVE NOT RECRUITING | Sinusitis

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

sunshine GU O key pharmaceutical (Shanghai) co., Ltd.

Brief Summary:

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

Condition or disease

Sinusitis

Nasal Polyps

Polyps

Intervention/treatment

611

Placebo

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2023-06-30
Estimated Primary Completion Date : 2024-05-31
Estimated Study Completion Date : 2024-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Location Details

NCT05865496

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Site 03

Beijing, Beijing, China, 100005

Not yet recruiting

China, Beijing

Site 01

Beijing, Beijing, China, 100730

Not yet recruiting

China, Hubei

Site 04

Wuhan, Hubei, China, 430022

Not yet recruiting

China, Jiangsu

Site 02

Xuzhou, Jiangsu, China, 221004