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A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.

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ClinicalTrials.gov Identifier: NCT00504270
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

July 18, 2007
July 19, 2007
November 2, 2016
July 2007
September 2009   (Final data collection date for primary outcome measure)
Adverse events (AEs), laboratory parameters, pharmacokinetics [ Time Frame: Throughout study ]
AEs, laboratory parameters, pharmacokinetics.
Complete list of historical versions of study NCT00504270 on ClinicalTrials.gov Archive Site
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers [ Time Frame: Throughout study ]
Change from baseline over time in static PGA score, PASI and exploratory biomarkers.
Not Provided
Not Provided
 
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: Placebo
    po daily
  • Drug: RG3421 120mg
    120mg po daily
  • Drug: RG3421 20mg
    20mg po daily
  • Placebo Comparator: Placebo
    po daily
    Intervention: Drug: Placebo
  • Experimental: RG3421 120mg
    120mg po daily
    Intervention: Drug: RG3421 120mg
  • Experimental: RG3421 20mg
    20mg po daily
    Intervention: Drug: RG3421 20mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
Not Provided
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • medically stable, moderate to severe chronic plaque psoriasis.

Exclusion Criteria:

  • any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
  • confounding or concomitant condition or treatment.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00504270
NS20454
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP