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

NCT ID: NCT00090129

Last Updated: 2013-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 854 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-06-30

Brief Summary

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.

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic Arthritis; Moderate plaque psoriasis; severe plaque psoriasis; Onercept; Placebo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Onercept

Group Type: EXPERIMENTAL

Onercept

Intervention Type: DRUG

Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.

Interventions

Onercept

Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.

Intervention Type: DRUG

Placebo

Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.

Intervention Type: DRUG

Other Intervention Names

recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
• Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments
• Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigator's discretion)
• Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study
• Bedridden status
• Previous use of onercept

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Locations

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

Oregon Medical Research Center, P.C.

Portland, Oregon, United States

Rivergate Dermatology

Goodlettsville, Tennessee, United States

Saint Mary's Centeral Wing Annex

Knoxville, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

DermResearch Inc

Austin, Texas, United States

Texas Dermatology Research Institute

Dallas, Texas, United States

Center For Clinical Studies

Houston, Texas, United States

University Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Dermatology Associates P.L.L.C.

Seattle, Washington, United States

Rockwood Clinic, PS

Spokane, Washington, United States

Probity Medical Research

Edmonton, Alberta, Canada

Guenther Dermatology Research Center

London, Ontario, Canada

Probity Medical Research

Waterloo, Ontario, Canada

Countries

United States; Canada

References

Papp K. Clinical development of onercept, a tumor necrosis factor binding protein, in psoriasis. Curr Med Res Opin. 2010 Oct;26(10):2287-300. doi: 10.1185/03007995.2010.507492.

Reference Type: RESULT

PMID: 20718590 (View on PubMed)

Other Identifiers

24979

Identifier Type: -

Identifier Source: org_study_id