Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT00090129

Run by

EMD Serono

People needed

854

Starts

2004-09-01

Expected to finish

2005-06-01

Last updated by the study team

2013-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
• At least 18 years of age
• Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
• Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
• Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
• An out-patient status at the time of enrollment
• Plaque psoriasis for at least 12 months
• Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
• Candidate for phototherapy or systemic therapy
• Static Physician's Global Assessment (sPGA) of 3 or more

You may not qualify if…

• Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
• Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
• Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
• Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
• Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
• Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
• Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
• Phototherapy within 28 days before Study Day 1
• Use of tanning booths within 14 days before Study Day 1
• Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values
• Inadequate bone marrow reserve, defined as:
• Leukocytes less than or equal to 3.5 * 10\^9 per liter (/L), or
• Thrombocytes less than or equal to 100 * 10\^9 /L, or
• Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).
• Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.
• Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)
• Planned major surgery within the treatment period of the study.
• History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer
• History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis
• Active severe infection (or non-severe infection at the discretion of the Investigator).
• History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency
• Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)
• Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study
• History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse
• Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study

Where it is running

• Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A. — Little Rock, Arkansas, United States
• Associates in Research Inc. — Fresno, California, United States
• University of California, Irvine — Irvine, California, United States
• Therapeutics Clinical Research — La Jolla, California, United States
• University of California — San Francisco, California, United States
• Clinical Research Specialists Inc. — Santa Monica, California, United States
• Solano Clinical Research — Vallejo, California, United States
• Dermatology Specialists Inc — Vista, California, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• Longmont Clinic PC — Longmont, Colorado, United States
• The Savin Center P.C. — New Haven, Connecticut, United States
• Dermatology Associates, P.C. at the Washington Hospital CTR — Washington D.C., District of Columbia, United States
• North Florida Dermatology Associates, P.A. — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• International Dermatology Research — Miami, Florida, United States
• Atlanta Dermatology Vein & Research Center — Alpharetta, Georgia, United States
• Scott D. Glazer, MD — Buffalo Grove, Illinois, United States
• University of Michigan Department of Dermatology — Ann Arbor, Michigan, United States
• Midwest Cutaneous Research Corporation — Clinton Township, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• Wake Forest Univ School of Medicine — Winston-Salem, North Carolina, United States
• Northwest Cutaneous Research Specialist — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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