A randomised, placebo-controlled, double-blind, left-right comparison, multi centre phase IIa study to investigate the efficacy and safety of M518101 in plaque psoriasis patients

• Conditions: Psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2009-010805-35-CZ
• Lead Sponsor: Maruho Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1.Who are able and willing to give signed informed consent at Visit 1.
2.Who are male or females aged between 18 and 65 years, inclusive, on the day of signing the informed consent form (ICF) with plaque psoriasis confirmed by the Investigator at Visit 1.
3.Who have less than 20% of BSA afflicted with plaques at Visits 1, 2, and 3.
4.Who have symmetrical (i.e., similar on the left and right side) psoriatic plaques (minimum size of each plaque: 10 cm2), each of which PSI score is =12 (at trunk [either chest, abdomen, or upper/lower back], upper or lower extremities) at Visit 3. A difference between the left and right target plaque in the total PSI score of up to ±4, and in each element of the PSI score of up to ±2, will be allowed.
5.Whose PSI score does not decrease by more than 6 on any of the symmetrical psoriatic plaques (target plaques) during the lead in period (between Visits 2 and 3).
6.Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Females with childbearing potential must have a negative serum pregnancy test on the day of signing the ICF (Visit 1), and must use a highly effective method of oral or injectable contraception during the study and for 90 days following completion of the last dose of study drug (non childbearing potential is defined as post menopausal for at least 2 years, or surgical sterilisation or hysterectomy at least 12 weeks before Visit 1). If male, he must be willing to use contraception to avoid contributing to pregnancies during the study and for 90 days following completion of the last dose of study drug.
7.Who are willing and able to comply with the trial procedures and to communicate clearly with the Investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (based on serum pregnancy test) or lactating.
5.Who have any renal (serum creatinine level >2 fold above upper limit of reference range) or hepatic insufficiency (alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase level >3 fold above upper limit of reference range), or clinically significant cardiac, renal or hepatic disease.
6.Who, in the opinion of the Investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7.Who, in the opinion of the Investigator, 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 at Visits 2 and 3 exceed the upper limit of reference range (>2.50 mmol/L).
9.Who have used M5181 (active ingredient of M518101) before the study.
10.Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks before Visit 3 (20 weeks before Visit 1).
11.Who have been treated with PUVA, ultraviolet A (UVA), UVB, oral retinoids, oral immunosuppressive/immunomodulative drugs, oral vitamin D3 derivatives, calcium preparations, hormone preparations for treatment of psoriasis, cyclosporine or methotrexate within 8 weeks before Visit 3 (4 weeks before Visit 1).
12.Who have been treated with biologics within 12 weeks before Visit 3 (8 weeks before Visit 1).
13.Who have been treated with topical steroids, topical immunosuppressive/immunomodulative drugs, topical vitamin D3 derivatives, topical retinoids, dithranol or coal tar on any part of the body during the wash-out and lead-in period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified