NCT Number: NCT01908595
Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Agave Clinical Research, Mesa, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Who are able and willing to give signed informed consent
- Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
- Who have up to 20% of body surface area (BSA) afflicted with plaques
- Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Exclusion criteria
- Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- 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.
- Whose serum calcium levels exceed the upper limit of reference range
- Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment.
- Who have been treated with systemic therapy within 30days of treatment.
- Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
- Who have been treated with topical therapy within 14days before the day of treatment.
Treatment and study plan
Primary outcomes
-
Time course change of Investigator Global Assessment
Time frame: 4 weeks interval
Sponsors and collaborators
Lead sponsor
Maruho North America Inc.
Industry
Registry information
Official study title
An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 25, 2013
- Registry last updated
- Sep 2, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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