Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06639295

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 01

Beijing, Beijing Municipality, 100730, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

611

Drug

611 subcutaneous (SC) injection.

Placebo

Drug

Placebo subcutaneous (SC) injection.

Primary outcomes

  1. Change From Baseline at Week 24 in Bilateral Nasal Polyp Score (NPS)

    Time frame: 24 weeks

    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

  2. Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score (NCS)

    Time frame: 24 weeks

    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.

Secondary outcomes

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

    Time frame: through study completion, an average of 13 months

    The Lund Mackay Score scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease

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

    Time frame: through study completion, an average of 13 months

    TNSS is a composite of nasal congestion, loss of smell, and rhinorrhea (anterior/posterior nasal discharge), each access on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranges from 0 (no symptoms) to 12 (severe symptoms). Higher score indicated more severe symptoms.

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

    Time frame: through study completion, an average of 13 months

    The UPSIT is a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss

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

    Time frame: through study completion, an average of 13 months

    The SNOT-22 is a validated questionnaire that used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life

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

    Time frame: through study completion, an average of 13 months

    The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

  6. 611 Concentration in Serum

    Time frame: through study completion, an average of 13 months

    The concentration of 611 in Serum

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.