Recruitment

Recruitment Status
Completed
Estimated Enrollment
522

Inclusion Criterias

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 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 able and willing to give signed informed consent
Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criterias

Who are pregnant or lactating.
Who have been treated with systemic therapy within 30days of randomization.
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 been treated with systemic therapy within 30days of randomization.
Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
Whose serum calcium levels exceed the upper limit of reference range
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
Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
Who have been treated with topical therapy within 14days before the day of randomization.

Summary

Conditions
Psoriasis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

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 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 able and willing to give signed informed consent
Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criterias

Who are pregnant or lactating.
Who have been treated with systemic therapy within 30days of randomization.
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 been treated with systemic therapy within 30days of randomization.
Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
Whose serum calcium levels exceed the upper limit of reference range
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
Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
Who have been treated with topical therapy within 14days before the day of randomization.

Locations

Norman, Oklahoma, 73071
Fountain Inn, South Carolina, 29644
Austin, Texas, 78705
Rochester, New York, 14623
Henderson, Nevada, 89052
...
Norman, Oklahoma, 73071
Fountain Inn, South Carolina, 29644
Austin, Texas, 78705
Rochester, New York, 14623
Henderson, Nevada, 89052
Encino, California, 91436
South Bend, Indiana, 46617
Warren, Michigan, 48088
Stony Brook, New York, 11790
San Antonio, Texas, 78229
Salt Lake City, Utah, 84117
Nashville, Tennessee, 37215
Austin, Texas, 78759
San Diego, California, 92108
Baton Rouge, Louisiana, 70808
Skokie, Illinois, 60077
St. Louis, Missouri, 63141
Lousville, Kentucky, 40202
San Diego, California, 92123
Aventura, Florida, 33180
Wilmington, North Carolina, 28403
Mesa, Arizona, 85202
Overland Park, Kansas, 66215
Santa Monica, California, 90404
Charlotte, North Carolina, 28209
East Windsor, New Jersey, 08520
Mt Pleasant, South Carolina, 29464
Cincinnati, Ohio, 45249
Louiville, Kentucky, 40217
Las Vegas, Nevada, 89106
Jacksonville, Florida, 32216
Denver, Colorado, 80220
Dallas, Texas, 75246
High Point, North Carolina, 27262

Tracking Information

NCT #
NCT01878461
Collaborators
Not Provided
Investigators
Not Provided