An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
An Open-Label, Multi-Center Pilot Trial to Assess the Efficacy and Safety of Oral R115866 in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
1 other identifier
interventional
19
1 country
2
Brief Summary
This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get active medication, there is no placebo arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedSeptember 26, 2011
July 1, 2008
11 months
July 17, 2008
September 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PASI Scores
Various Visits
Study Arms (1)
A
EXPERIMENTALR115866
Interventions
Eligibility Criteria
You may qualify if:
- Presence of moderate to severe plaque psoriasis with a PASI of at least 5
You may not qualify if:
- Pustular, guttate or other non-plaque forms of psoriasis or psoriatic arthritis
- Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
- Use of vitamin A (\>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroidal anti-inflammatory drugs, non-potassium-sparing diuretics
- Previous use of any systemic immunomodulatory therapy (biologicals) or psoriasis vaccine
- Use of other systemic therapy for psoriasis (e.g. PUVA, systemic steroids, cyclosporin A, methotrexate, retinoids) within four weeks prior to Visit 2
- Use of UV therapy or excessive UV exposure or topical therapy for psoriasis other than bland emollients within two weeks prior to Visit 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Universitair Medisch Centrum Nijmegen Sint Radboud
Nijmegen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. P. van de Kerkhof, MD, PhD
University of Nijmegen, Maastricht, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 30, 2008
Study Start
April 1, 2004
Primary Completion
March 1, 2005
Study Completion
December 1, 2006
Last Updated
September 26, 2011
Record last verified: 2008-07