Last updated: 11/04/2018 05:46:59
Dose ranging study of the safety and efficacy of R115966 in plaque psoriasis
GSK study ID
BT0720-201-INT
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Psoriasis Area Severity Index (PASI)75 success at Visit 6
Timeframe: Week 12 (Visit 6)
Secondary outcomes:
PASI50 success (the reduction in PASI score at each visit of at least 50 percent relative to Visit 2) at each post baseline visit
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8)
Investigator's Global Assessment (IGA) at each post baseline visit
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8)
PASI75 at each post baseline visit except visit 6
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)
Interventions:
Drug: Talarozole
Enrollment:
176
Observational study model:
Not applicable
Primary completion date:
2007-01-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
talarazole
Collaborators
GSK
Study date(s)
June 2006 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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);
- Spontaneously improving or rapidly deteriorating plaque psoriasis
- Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
Inclusion and 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
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-01-05
Actual study completion date
2007-01-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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