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
1 other identifier
interventional
66
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
15 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
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 2, 2016
November 1, 2016
2.2 years
July 18, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs), laboratory parameters, pharmacokinetics
Throughout study
Secondary Outcomes (1)
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Throughout study
Study Arms (3)
Placebo
PLACEBO COMPARATORpo daily
RG3421 120mg
EXPERIMENTAL120mg po daily
RG3421 20mg
EXPERIMENTAL20mg po daily
Interventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-70 years of age;
- medically stable, moderate to severe chronic plaque psoriasis.
You may not qualify if:
- any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- confounding or concomitant condition or treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Alpharetta, Georgia, 30005, United States
Unknown Facility
East Windsor, New Jersey, 08520, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Stony Brook, New York, 11790, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Providence, Rhode Island, 02903, United States
Unknown Facility
Nashville, Tennessee, 37215, United States
Unknown Facility
Galveston, Texas, 77550, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 19, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11