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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2061240008
Enrollment
45
Registered
2024-05-10
Start date
2024-05-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis

Interventions

M127101 or M127101 placebo will be administered once daily via inhalation using a nebulizer

Sponsors

Nishiura Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Nasal Polyp Score—

Contacts

Public ContactClinical Trials Information -

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-75-325-3279

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026