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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00925574
First received: June 16, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CNTO 1959; Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis. [ Time Frame: Assessments will occur at each study visit and up to 24 weeks following administration of study agent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics. [ Time Frame: Assessments will occur at study visits through 24 weeks following administration of study agent. ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: Assessments will occur at study visits through 24 weeks following administration of study agent. ] [ Designated as safety issue: No ]
  • Immune Response [ Time Frame: Assessments will occur at study visits through 24 weeks following administration of study agent. ] [ Designated as safety issue: No ]
  • Clinical Response [ Time Frame: Assessments will occur at study visits through 24 weeks following administration of study agent. ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925574

Locations
United States, California
Los Angeles, California, United States
San Diego, California, United States
United States, Florida
Miramar, Florida, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, Oregon
Portland, Oregon, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00925574     History of Changes
Other Study ID Numbers: CR015817, CNTO1959PSO1001, CR015817
Study First Received: June 16, 2009
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
CNTO 1959
Healthy Volunteers
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014