Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00716144
• Date of registration: 15/07/2008
• Prospective Registration: No
• Primary sponsor: Stiefel, a GSK Company
• Public title: Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
• Scientific title: A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study of the Safety and Efficacy of Oral R115866 and R115866 Placebo in the Treatment of Plaque Psoriasis
• Date of first enrolment: June 2006
• Target sample size: 176
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00716144
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany, Ireland, Netherlands, Russian Federation, United Kingdom

Contacts

• Name: Christopher EM Griffiths, MD
• Affiliation: Hope Hospital, University of Manchester, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Plaque Psoriasis with PASI greater than or equal to 10

- Male or a female who was NOT of childbearing potential (i.e., post-
menopausal for greater than 12 months or had a complete hysterectomy);

Exclusion Criteria:

- Spontaneously improving or rapidly deteriorating plaque psoriasis

- Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis

- Subject was under treatment for a heart disorder or had a history of cardiovascular
disease (excluding effectively controlled hypertension)

- Any acute psychiatric condition, including an increased risk for suicide attempt,
based on medical and psychiatric history

- Previous use of a psoriasis vaccine or had participated in an investigational study
of a psoriasis vaccine

- Previous use of systemic immunomodulatory therapy known to affect psoriasis and to
typically decrease immune cell populations

- Previous use of any systemic immunomodulatory therapy known to affect psoriasis and
NOT typically to decrease immune cell populations

- Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic
psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or
cyclosporine) within the previous four weeks

- Pregnant or a nursing mother

- Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia,
chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a
positive test for human immunodeficiency virus (HIV), a history indicating adrenal
cortex dysfunction



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: Talarozole

Primary Outcome(s)

PASI75 success at Visit 6 [Time Frame: Visit 6 (post 12 weeks on treatment)]

Secondary Outcome(s)

PASI75 [Time Frame: each post-baseline visit except Visit 6]

Investigator's Global Assessment [Time Frame: each post-baseline visit]

PASI50 [Time Frame: each post-baseline visit]

Secondary ID(s)

BT0720-201-INT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors