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Phase II study of M118103 in the treatment of nodular prurigo which does not respond to topical steroid treatment

Phase II study of M118103

29

The majority of participants were female (69.0%). The age of participants ranged from 19 to 77 years old, with the mean age of 45.

Of the 41 participants enrolled in this study, 29 were randomized, excluding 12 who discontinued the study during the run-in period. The investigational products were administered to all 29 randomized participants. However, among these, 2 participants discontinued the study due to adverse events considered to make it difficult for the participants to continue the study.

The incidence of adverse events, regardless of their causality with the investigational product, was 41.4% (12 of 29 participants). Of these, adverse events considered related to M118103 accounted for 6.9% (2 of 29), and those considered related to diflorasone diacetate ointment were 17.2% (5 of 29). The severity of all adverse events was either moderate or mild, with no serious adverse events reported after randomization. Significant adverse events leading to study treatment discontinuation occurred in two participants (application site dermatitis and application site erythema each). The investigational products showed no effects on clinical laboratory values.

No primary endpoint for efficacy was set because this study was exploratory.

Overall assessment and severity of skin findings improved over time with all investigational products, with a greater improvement rate in diflorasone diacetate ointment. In side-to-side comparison of therapeutic effects, diflorasone diacetate ointment was superior to M118103. The diameter, thickness, and number of nodules, as well as pruritus NRS and pruritus VAS, decreased over time with all investigational products, with a greater reduction in diflorasone diacetate ointment.

This study was conducted to explore efficacy endpoints appropriate for nodular prurigo. The results showed that endpoints for overall lesions, for individual nodules and for pruritus, were considered acceptable to evaluate the effects on prurigo modulars. Regarding safety, the severity of all adverse events was mild or moderate, and adverse events leading to discontinuation of study treatment were resolved or resolving. Therefore, treatment with M118103 was considered to have no significant clinical issues.

July. 05, 2024

No

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

completed

Feb. 20, 2018

Interventional

Active-control, randomized, open-label, right and left comparision, exploratory, multi-center study

treatment purpose

2

Patients with nodular prurigo which does not respond to topical steroid treatment patients

1) Patients who have a history or presence of serious drug hyper sensivity
2) Patients who have cardiac, hepatic, renal, pulmonary, blood disease considered inappropriate for participation in clinical trials

Both

Nodular prurigo which does not respond to topical steroid treatment

investigational material(s)
Generic name etc : M118103
INN of investigational material : Heparinoid
Therapeutic category code : 333 Anticoagulants
Dosage and Administration for Investigational material : Topical

control material(s)
Generic name etc : Diflorasone Diacetate ointment
INN of investigational material : Diflorasone Diacetate ointment
Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammatory agents
Dosage and Administration for Investigational material : Topical

efficacy
exploratory
IGA, pruritus
The investigator will assess IGA at every visit and patients will assess NRS every day.

safety
NA
NA

Mar. 15, 2019