Overview

Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maruho Co., Ltd.
Treatments:
Calcipotriene
Criteria
Inclusion Criteria:

1. Who are able and willing to give signed informed consent

2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the
Investigator.

3. Who have less than 20% of body surface area (BSA) afflicted with plaques

4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the
study.

Exclusion Criteria:

1. Who have a history of allergy to vitamin D3 derivative preparations.

2. Who have a history of relevant drug hypersensitivity.

3. Who have a history of contact dermatitis induced by a topical medicine.

4. Who are pregnant or lactating.

5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal
or hepatic disease.

6. Who are not deemed eligible as determined by medical history, physical examination or
clinical laboratory safety tests.

7. Who have clinically relevant history or presence of any disease or surgical history
other than psoriasis which is likely to affect the conduct of the study.

8. Whose serum calcium levels exceed the upper limit of reference range

9. Who have used any investigational medicinal product and/or participated in any
clinical study within 60 days before the day of signing the ICF.

10. Who have been treated with systemic therapy within 2 weeks before the day of signing
the ICF and during the wash-out period.

11. Who have been treated with biologics within 5 half-lives of the biologics before the
day of randomization.

12. Who have been treated with topical therapy during the wash-out period.