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

NCT00090129 | Terminated Phase 3

• 1 other identifier: 24979
• Study Type: interventional
• Target: 854
• Locations: 2 countries
• Sites: 40

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

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12

  Week 12

• Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52

  Week 52

Secondary Outcomes (10)

• Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12

  Week 12

• Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score

  Baseline up to Week 12

• Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score

  Baseline up to Week 12

• Mean percentage improvement in the itching scale

  Baseline up to Week 12

• Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12

  Baseline and Week 12

Study Arms (2)

Onercept

EXPERIMENTAL

Drug: Onercept

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Onercept 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.

Also known as: recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)

Onercept

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (40)

Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.

Little Rock, Arkansas, 72205, United States

Location

Associates in Research Inc.

Fresno, California, 93710, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Therapeutics Clinical Research

La Jolla, California, 92037, United States

Location

University of California

San Francisco, California, 94108, United States

Location

Clinical Research Specialists Inc.

Santa Monica, California, 90404, United States

Location

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Dermatology Specialists Inc

Vista, California, 92083, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80246, United States

Location

Longmont Clinic PC

Longmont, Colorado, 80501, United States

Location

The Savin Center P.C.

New Haven, Connecticut, 06511, United States

Location

Dermatology Associates, P.C. at the Washington Hospital CTR

Washington D.C., District of Columbia, 20010, United States

Location

North Florida Dermatology Associates, P.A.

Jacksonville, Florida, 32204, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

Atlanta Dermatology Vein & Research Center

Alpharetta, Georgia, 30005, United States

Location

Scott D. Glazer, MD

Buffalo Grove, Illinois, 60089, United States

Location

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

Midwest Cutaneous Research Corporation

Clinton Township, Michigan, 48038, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Northwest Cutaneous Research Specialist

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center, P.C.

Portland, Oregon, 97223, United States

Location

Rivergate Dermatology

Goodlettsville, Tennessee, 37072, United States

Location

Saint Mary's Centeral Wing Annex

Knoxville, Tennessee, 37917, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37221, United States

Location

DermResearch Inc

Austin, Texas, 78759, United States

Location

Texas Dermatology Research Institute

Dallas, Texas, 75230, United States

Location

Center For Clinical Studies

Houston, Texas, 77030, United States

Location

University Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Center for Clinical Studies

Houston, Texas, 77058, United States

Location

Virginia Clinical Research, Inc

Norfolk, Virginia, 23507, United States

Location

Dermatology Associates P.L.L.C.

Seattle, Washington, 98101, United States

Location

Rockwood Clinic, PS

Spokane, Washington, 99202, United States

Location

Probity Medical Research

Edmonton, Alberta, T5J3S9, Canada

Location

Guenther Dermatology Research Center

London, Ontario, N6A 3H7, Canada

Location

Probity Medical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 20718590 RESULT

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

recombinant human tumor necrosis factor-binding protein-1

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2004
• First Posted: August 26, 2004
• Study Start: September 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

CA (3); US (37)