A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT ID: NCT05865496
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2023-06-30
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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611 Dose A
611 300 mg Q2W, subcutaneous (SC) injection.
611
611 subcutaneous (SC) injection.
611 Dose B
611 450 mg Q4W, subcutaneous (SC) injection.
611
611 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Interventions
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611
611 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Qinghong Zhou, BS
Role: STUDY_DIRECTOR
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Luo Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Site 03
Beijing, Beijing Municipality, China
Site 01
Beijing, Beijing Municipality, China
Site 04
Wuhan, Hubei, China
Site 02
Xuzhou, Jiangsu, China
Countries
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Other Identifiers
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SSGJ-611-CRS-II-01
Identifier Type: -
Identifier Source: org_study_id
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