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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

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(1) 0.0003% M127101 group (M127101 group) - Age(mean): 56.4 years - Sex: 21 male participants(63.6%) - Race: 100% Asian - Baseline nasal polyp score (nasal endoscopy) (mean): 5.2 - Baseline nasal obstruction severity score(mean): 1.75 - Time since first onset of nasal polyps associated with eosinophilic chronic rhinosinusitis (median) (minimum, maximum): 8.12(0.3, 34.7) years - Proportion of participants with a first-time onset of nasal polyps associated with eosinophilic chronic rhinosinusitis: 60.6% (2) M127101 vehicle group (vehicle group) - Age(mean): 59.8 years - Sex: 10 male participants(62.5%) - Race: 100% Asian - Baseline nasal polyp score (nasal endoscopy) (mean): 5.6 - Baseline nasal obstruction severity score(mean): 1.77 - Time since first onset of nasal polyps associated with eosinophilic chronic rhinosinusitis (median) (minimum, maximum): 2.92(0.5, 30.6)years - Proportion of participants with a first-time onset of nasal polyps associated with eosinophilic chronic rhinosinusitis: 75.0%

Participant disposition (1) M127101 group - Received the study drug: 33 - Completed the study: 32 - Discontinued the study: 2 (2) Vehicle group - Received the study drug: 16 - Completed the study: 15 - Discontinued the study: 1

Safety analyses were performed in the safety analysis set (33 participants in the M127101 group and 16 participants in the vehicle group). The incidence of adverse events was 63.6% (21 of 33 participants) in the M127101 group and 43.8% (7 of 16 participants) in the vehicle group. All the severities were mild except for 2 participants of moderate (1 participant of herpes zoster [M127101 group] and 1 participant of influenza [vehicle group]). No treatment-related adverse events were observed in the M127101 group, compared to one participant reported in the vehicle group (asthma, mild). There were no deaths or other serious adverse events. Adverse events leading to discontinuation of the study drug were observed in the vehicle group only (1 participant of asthma, treatment-related). However, no adverse events led to dose interruption or dose reduction of the study drug in either group. As treatment-emergent adverse event(TEAE)s of special interest, respiratory function-related TEAEs were observed in 1 participant each in the M127101 group and the vehicle group, coagulation/fibrinolysis-related TEAEs were observed in 2 participants in the M127101 group, allergic or hypersensitivity symptoms suspected to be caused by the study drug were observed in 2 participants each in the M127101 group and the vehicle group. Severity of all adverse events were mild and only one participant in the vehicle group (asthma, mild, previously stated) was reported as treatment related. Except for epistaxis of coagulation/fibrinolysis-related TEAE in the M127101 group (1 participant, not resolved), the adverse events resolved. No significant changes were observed in clinical laboratory values between pre- and post-administration of the study drug. No significant changes were observed in respiratory function tests (peak flow) between pre- and post-administration of the study drug.

As this was an exploratory study, no primary or secondary endpoints were set. Important efficacy endpoints: (1) Nasal polyp score (nasal endoscopy) The least squares mean (95% confidence interval) of the nasal polyp score evaluated by the investigator through nasal endoscopy showed no change in the M127101 group, with a baseline of 5.2(4.8, 5.6) and 5.3(4.8, 5.7) after 16 weeks of administration. The vehicle group also showed no change, with scores of 5.6 (5.0, 6.1) and 5.4 (4.7, 6.1). (2) Nasal obstruction severity score The weekly average least squares mean (95% confidence interval) of the nasal obstruction severity score showed no change in the M127101 group, with a baseline of 1.75(1.53, 1.97) and 1.66(1.35, 1.97) after 16 weeks of administration. The vehicle group also showed no change, with scores of 1.77 (1.46, 2.08) and 1.57 (1.12, 2.03).

Participants with nasal polyps associated with eosinophilic chronic rhinosinusitis were administered 0.0003% M127101 once daily for 16 weeks. No improvement was observed in any efficacy endpoints, including nasal polyp score (nasal endoscopy) and nasal obstruction severity score, following M127101 administration. No safety issues associated with M127101 administration were observed.

Feb. 10, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2061240008

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 Chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

- Clinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

May. 10, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

- 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

Both

Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis

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

Nasal Polyp Score

+81-836-22-2428

April. 16, 2024

none