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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00504270 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: R3421 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 170 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: R3421
20mg po daily
|
| 2: Experimental |
Drug: R3421
120mg po daily
|
| 3: Placebo Comparator |
Drug: Placebo
po daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: NS20454 | 973-235-5000 | |
| Contact: or | 800-526-6367 (FOR US ONLY) |
| United States, Arkansas | |
| LITTLE ROCK, Arkansas, United States, 72205 | |
| HOT SPRINGS, Arkansas, United States, 71913 | |
| United States, California | |
| SANTA MONICA, California, United States, 90404 | |
| United States, Georgia | |
| ALPHARETTA, Georgia, United States, 30005 | |
| United States, New Jersey | |
| EAST WINDSOR, New Jersey, United States, 08520 | |
| United States, New Mexico | |
| ALBUQUERQUE, New Mexico, United States, 87106 | |
| United States, New York | |
| NEW YORK, New York, United States, 10029 | |
| NEW YORK, New York, United States, 10016 | |
| STONY BROOK, New York, United States, 11790 | |
| United States, North Carolina | |
| WINSTON-SALEM, North Carolina, United States, 27157 | |
| United States, Rhode Island | |
| PROVIDENCE, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| NASHVILLE, Tennessee, United States, 37215 | |
| United States, Texas | |
| SAN ANTONIO, Texas, United States, 78229 | |
| GALVESTON, Texas, United States, 77550 | |
| HOUSTON, Texas, United States, 77058 | |
| Study Chair: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | NS20454 |
| Study First Received: | July 18, 2007 |
| Last Updated: | August 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00504270 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
|
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
