Clinical trial NCT05865496: A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sinusitis
Nasal Polyps
Polyps
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
timeFrame: Up to 16 weeks
measure: Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change From Baseline to the End of study in Lund Mackay Score
timeFrame: Up to 16 weeks
measure: Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
timeFrame: Up to 16 weeks
measure: Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
timeFrame: Up to 16 weeks
measure: Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
timeFrame: Up to 16 weeks
measure: 611 Concentration in Serum
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site 03
state: Beijing
city: Beijing
country: China
facility: Site 01
state: Beijing
city: Wuhan
country: China
facility: Site 04
state: Hubei
city: Xuzhou
country: China
facility: Site 02
state: Jiangsu
Study officials:
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, BS
role: STUDY_DIRECTOR
affiliation: Beijing Tongren Hospital
name: Luo Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: