A Study of the Safety and How the Body Affects a Drug (CNTO 1959) in Healthy Volunteers and in Patients With Psoriasis

A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects With Moderate to Severe Psoriasis

The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO 1959) in healthy volunteers and in patients with psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: CNTO 1959; Placebo

Detailed Description

CNTO 1959 is an experimental drug. In this study, CNTO 1959 will be tested to see if it may be useful in treating psoriasis. This disease causes inflammation of skin and nails. This is a Randomized (study drug assigned by chance), Double-blind (neither physician nor patient knows the name of the assigned drug), Placebo-controlled study of the experimental drug CNTO 1959 in both healthy patients as well as patients with psoriasis. This study will compare the effects (both good and bad) of CNTO 1959 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 1959 given to healthy volunteers and patients with moderate to severe psoriasis. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 1959, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. This is the first time that CNTO 1959 will be studied in humans. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with psoriasis. About 47 healthy volunteers and 24 patients with moderate to severe psoriasis will take part in the study. Enrollment for the healthy volunteer part is closed as of 23SEP09. CNTO 1959 will be administered as either an intravenous (IV) infusion or subcutaneous (SC) injection. Duration of participation may be up to 28 weeks.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
    • San Diego, California, United States
  • Florida
    • Miramar, Florida, United States
  • Kansas
    • Overland Park, Kansas, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New York
    • New York, New York, United States
  • Oregon
    • Portland, Oregon, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female with no clinically significant abnormalities and have a body weight of 50 to 100 kg (Enrollment of healthy volunteers closed on 23SEP09)
• Patients with moderate to severe psoriasis and have a body weight not greater than 120 kg.

Exclusion Criteria:

• Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the patient, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, respiratory disease, hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
• Known or recent history of alcohol or drug abuse
• Major or traumatic surgery within 12 weeks of screening
• Donated blood greater than 500 ml within 56 days of screening
• Pregnant or nursing
• Have recently received phototherapy or any systemic medications/treatments that could affect psoriasis

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis.	Assessments will occur at each study visit and up to 24 weeks following administration of study agent

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics.	Assessments will occur at study visits through 24 weeks following administration of study agent.
Pharmacodynamics	Assessments will occur at study visits through 24 weeks following administration of study agent.
Immune Response	Assessments will occur at study visits through 24 weeks following administration of study agent.
Clinical Response	Assessments will occur at study visits through 24 weeks following administration of study agent.

Collaborators and Investigators

• Sponsor: Centocor, Inc.

Publications and helpful links

Helpful Links

• Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects with Moderate to Severe Psoriasis

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2009
• Primary Completion (Actual): October 11, 2010
• Study Completion (Actual): October 11, 2010

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 19, 2009
• First Posted (Estimate): June 22, 2009

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Psoriasis; Healthy Volunteers; CNTO 1959
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CR015817; CNTO1959PSO1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No