A Phase 2, Randomized, Placebo-controlled, Double-Blind, Parallel Group, Multi-Center Study to Evaluate Efficacy and Safety of M127101 in Subjects with Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis

JRCT ID: jRCT2061240008

Registered date:10/05/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis
• Date of first enrollment: 16/05/2024
• Target sample size: 45
• Study type: Interventional
• Intervention(s): M127101 or M127101 placebo will be administered once daily via inhalation using a nebulizer

Outcome(s)

• Primary Outcome: Nasal Polyp Score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

- Patients with Eosinophilic Chronic Rhinosinusitis
- Patients with nasal polyps in both nasal cavities
- Patients with Nasal Congestion symptoms

Exclude criteria

- Patients scheduled to undergo endoscopic sinus surgery during the clinical trial period
- Patients with severe Asthma
- Patients who cannot undergo sinus CT examination
- Patients with presence of serious cardiac, hepatic, renal, pulmonary, hematologic, or other diseases considered inappropriate for participation in the clinical study
- Patients who are Pregnant or breastfeeding
- Patients who have not completed 120 days since participation in another clinical trial or are currently participating in another clinical trial

Related Information

• Primary Sponsor: Nishiura Tomoyuki