Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396422
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2006-11-03
Brief Title:
Study to Investigate the Safety Tolerability Absorption Distribution Metabolism and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Phase IIa Randomized Double-blind Placebo-Controlled Parallel Group Multi-Center Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of RWJ-445380 Administered to Patients With Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the safety and tolerability of 50 100 200 and 300 mgday doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis
Detailed Description:
Trials with a new first-in-class drug will be done to ascertain safety tolerability absorption and other effects in the treatment of psoriasis such as effects on biomarkers Approximately 60 adult patients with psoriasis covering at least 3 percent of their body surface area will be recruited for the study They will be randomly assigned to one of 5 treatment arms each patient has an equal chance of receiving the placebo 50 mg 100 mg 200 mg or 300 mg dose Patients will receive study medication in a blinded fashion ie the patient the doctor and the study sponsor will not know what group the patient is in until all patients complete the study Patients will take the medication daily for 12 weeks The study will be enrolled in two enrollment groups of about 30 patients each so that extent of side effects can be ascertained and expectations on their extent confirmed The investigator and the sponsor will monitor the study for the occurrence of possible side effects In addition to a screening visit patients will have visits every week for the first month and then every two weeks until 12 weeks of treatment At 12 weeks there are 2 visits on consecutive days for tests and there is one followup visit 4 weeks after the last dose of study drug is taken
Medical history physical examination blood pressure and heart rate and ECGs are checked periodically Blood samples will be taken for standard laboratory tests as well as special tests of the drug blood level biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation and skin biopsies from areas both involved and not involved with psoriasis The blood and skin samples will be used to see whether some of the characteristics of psoriasis are changed by taking the drug Samples will also be taken to see whether certain types of immune cells are affected by taking the drug Immunizations with tetanus and hepatitis A vaccines will be done to see if taking the drug might affect immune responses to these agents Patients will receive RWJ-445380 50 100 200 300 mg or placebo Patients will receive an oral capsule daily for up to 12 weeks
Medical history physical examination blood pressure and heart rate and ECGs are checked periodically Blood samples will be taken for standard laboratory tests as well as special tests of the drug blood level biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation and skin biopsies from areas both involved and not involved with psoriasis The blood and skin samples will be used to see whether some of the characteristics of psoriasis are changed by taking the drug Samples will also be taken to see whether certain types of immune cells are affected by taking the drug Immunizations with tetanus and hepatitis A vaccines will be done to see if taking the drug might affect immune responses to these agents Patients will receive RWJ-445380 50 100 200 300 mg or placebo Patients will receive an oral capsule daily for up to 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None