An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725348
• Other study ID #: BT0700NED001
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2008
• Last updated: September 23, 2011
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2006
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female of non-childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion)

• Presence of moderate to severe plaque psoriasis with a PASI of at least 5

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Talarozole
1.0 mg oral dose per day

Locations

Country	Name	City	State
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Universitair Medisch Centrum Nijmegen Sint Radboud	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Stiefel, a GSK Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI Scores		Various Visits	No