Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis

February 17, 2011 updated by: Alza Corporation, DE, USA

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

The primary objective of the study is to evaluate the safety and tolerability of 50, 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, i.e, 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of plaque psoriasis for at least 6 months
  • willingness to undergo tissue biopsies

Exclusion Criteria:

  • No current oral or injectable medications for psoriasis (30 days to 3 months)
  • no other major health issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory assessments, physical exam and ECGs in patients with psoriasis

Secondary Outcome Measures

Outcome Measure
Explore effectiveness of drug through accepted psoriasis clinical measures and biomarkers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alza Corporation, DE, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 6, 2006

First Posted (Estimate)

November 7, 2006

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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