ID

43063

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01194219

Länk

http://clinicaltrials.gov/show/NCT01194219

Nyckelord

  1. 2013-03-19 2013-03-19 - Martin Dugas
  2. 2014-04-19 2014-04-19 - Julian Varghese
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility NCT01194219 Plaque Psoriasis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Alter mindestens 18 Jahre
Males or females, ≥ 18 years of age at the time of signing the informed consent document
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
Have moderate to severe plaque psoriasis at Screening and Baseline
Must meet all laboratory criteria
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
Ausschlusskriterien
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Pregnant or breast feeding
History of allergy to any component of the study drug
Hepatitis B surface antigen positive at Screening
Anti-hepatitis C antibody positive at Screening
Active tuberculosis (TB) or a history of incompletely treated TB
Clinically significant abnormality on 12-Lead ECG at Screening
Clinically significant abnormal chest x-ray
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
Psoriasis flare or rebound within 4 weeks prior to Screening
Evidence of skin conditions that would interfere with clinical assessments
Topical therapy within 2 weeks of randomization
Systemic therapy for psoriasis within 4 weeks prior to randomization
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Use of any investigational drug within 4 weeks prior to randomization
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Prior treatment with apremilast

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