|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00563524 |
Purpose
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: ILV-094 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of ILV-094 Administered Subcutaneously or Intravenously to Subjects With Psoriasis |
| Estimated Enrollment: | 6 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: ILV-094
Each subject receives ILV-094 or Placebo every 2 weeks for a total of 4 administations
|
To evaluate the clinical effect of ILV-094 on psoriasis activity as defined by change in the psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Trial Manager | clintrialparticipation@wyeth.com |
| United States, California | |
| Completed | |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| Recruiting | |
| Miami, Florida, United States, 33173 | |
| United States, Indiana | |
| Enrolling by invitation | |
| Indianapolis, Indiana, United States, 46256 | |
| Recruiting | |
| Evansville, Indiana, United States, 47714 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States | |
| United States, Missouri | |
| Enrolling by invitation | |
| St. Louis, Missouri, United States, 63117 | |
| United States, New York | |
| Enrolling by invitation | |
| New York, New York, United States, 10028 | |
| Recruiting | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Withdrawn | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Withdrawn | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Enrolling by invitation | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| Enrolling by invitation | |
| Dallas, Texas, United States, 75246 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| Enrolling by invitation | |
| Toronto, Ontario, Canada, M9L3A2 | |
| Enrolling by invitation | |
| Montreal, Ontario, Canada, H2K4L5 | |
| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3199K2-1105 |
| Study First Received: | November 21, 2007 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00563524 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
|
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
