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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 18, 2007
First Posted Date  ICMJE July 19, 2007
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE July 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Adverse events (AEs), laboratory parameters, pharmacokinetics [ Time Frame: Throughout study ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
AEs, laboratory parameters, pharmacokinetics.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
Change from baseline over time in static PGA score, PASI and exploratory biomarkers.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Placebo
    po daily
  • Drug: RG3421 120mg
    120mg po daily
  • Drug: RG3421 20mg
    20mg po daily
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2010)
66
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00504270
Other Study ID Numbers  ICMJE NS20454
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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