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A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis


Phase 3
18 Years
75 Years
Not Enrolling
Both
Psoriatic Arthritis

Thank you

Trial Information

A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis


Inclusion Criteria:



Subjects must fulfill all of the following criteria before randomization at Study Day 1:

- 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subject's normal medical care, with the understanding that consent may be withdrawn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.

- Between the ages 18 and 75 years, inclusive.

- Female subjects must be neither pregnant nor breast-feeding, and must lack
childbearing potential, as defined by either:

- Being post-menopausal (i.e. at least 12 months past last menses) or surgically
sterile, or

- Using an effective form of contraception (i.e. condoms, oral contraceptives or
IUD).

[Confirmation that the subject is not pregnant must be established by a negative urinary
hCG test within 7 days before SD1. A pregnancy test is not required if the subject is
post-menopausal or surgically sterile.]

- An outpatient status at the time of enrollment.

- Plaque psoriasis for at least 12 months.

- Plaque psoriasis covering at least 10% 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:

To be eligible for inclusion in this study, the subjects must not meet any of the
following criteria:

- Use of more than one NSAID or having a change in NSAID regimen during the 28 days
before SD1. Note for guidance: subjects with psoriatic arthritis who are not
expected to be controlled with one stable dosing NSAID regimen throughout the entire
duration of the study should not be included.

- Previous systemic treatment with biologics, including interferon, and/or
cytokines/anti cytokines (e.g., anti-TNF-alpha, anti-CD4, IL-10, IL-1ra, anti-CD11a,
etc.) within 3 months before SD1.

- Participation in any other investigational study or experimental therapeutic
procedure considered to interfere with the study within 3 months before SD1
(exceptions to be discussed with Sponsor).

- Treatment with any systemic corticosteroids or intra-articular corticosteroid
injection during the 28 days before SD1.

- Any previous treatment with chlorambucil or cyclophosphamide.

- Treated with cyclosporine or methotrexate or oral retinoids within 28 days prior to
SD1.

- Treatment with topical therapies (vitamin D derivatives, corticosteroids) within 14
days before SD1.

- Phototherapy within 28 days before SD1.

- Use of tanning booths within 14 days before SD1.

- Abnormal liver function, defined by a total bilirubin>/= 1.2 times the upper limit of
normal values, aspartate aminotransferase, alanine aminotransferase or alkaline
phosphatase level>/= 1.5 times the upper limit of normal values.

- Inadequate bone marrow reserve, defined as:

- Leukocytes
- Thrombocytes
- Hemoglobin
- Abnormal renal function, defined by serum creatinine >150 micromol/L.

- Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV), 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).

- History of active tuberculosis, current active tuberculosis or current treatment or
prophylactic therapy for tuberculosis.

- Active severe infection (or non-severe infection at the discretion of the
Investigator).

- Opportunistic infection in the 3 months preceding SD1.

- 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 are scheduled at least 14 days
prior to SD1 or >3 months after the last injection of study drug).

- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of
psoriasis.

- Evidence of skin conditions other than psoriasis (e.g., eczema) that would interfere
with psoriasis disease assessments.

- Clinically significant psoriasis flare 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 SD1).

- Wheelchair-bound or bedridden status.

- Previous use of onercept.

In order to participate in this trial a subject must meet all of the inclusion and
exclusion criteria specified above. Requests for protocol exceptions/exemptions must come
from a participating, fully initiated site at which a prospective patient has consented to
undergo screening by the Trial Director. There is no program in place to allow drug for a
single patient IND, or for an expanded access protocol. This statement holds true for both
children and adults.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

24979

NCT ID:

NCT00090129

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Psoriatic Arthritis
  • DLQI - Dermatology life quality index
  • Plaque PASI - Psoriasis area and severity index
  • TH1- medicated
  • CD4+
  • CD8+
  • PGA- Physician's Global Assessment
  • PsA - Psoriatic arthritis
  • Arthritis
  • Arthritis, Psoriatic
  • Psoriasis

Name

Location

Rockwood Clinic, PSSpokane, Washington  99220
University of California, IrvineOrange, California  92868
Wake Forest Univ School of MedicineWinston Salem, North Carolina  27157-1082
Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.Little Rock, Arkansas  72205
Associates in Research Inc.Fresno, California  93710
Therapeutics Clinical ResearchLa Jolla, California  92037
University of CaliforniaSan Francisco, California  94108
Clinical Research Specialists Inc.Santa Monica, California  90404
Solano Clinical ResearchVallejo, California  94589
Dermatology Specialists IncVista, California  92083
Colorado Medical Research CenterDenver, Colorado  80210
Cherry Creek Research, Inc.Denver, Colorado  80246
Longmont Clinic PCLongmont, Colorado  80501
The Savin Center P.C.New Haven, Connecticut  06511
Dermatology Associates, P.C. at the Washington Hospital CTRWashington, District of Columbia  20010
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
North Florida Dermatology Associates, P.A.Jacksonville, Florida  32204
International Dermatology ResearchMiami, Florida  33144
Atlanta Dermatology Vein & Research CenterAlpharetta, Georgia  30005
Scott D. Glazer, MDBuffalo Grove, Illinois  60089
University of Michigan Department of DermatologyAnn Arbor, Michigan  48109
Midwest Cutaneous Research CorporationClinton Township, Michigan  48038
Minnesota Clinical Study CenterFridley, Minnesota  55432
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Piedmont Medical Research AssociatesWinston Salem, North Carolina  27103
Northwest Cutaneous Research SpecialistPortland, Oregon  97210
Oregon Medical Research Center, P.C.Portland, Oregon  97223
Rivergate DermatologyGoodlettsville, Tennessee  37072
Saint Mary's Centeral Wing AnnexKnoxville, Tennessee  37917
Tennessee Clinical Research CenterNashville, Tennessee  37221
DermResearch IncAustin, Texas  78759
Texas Dermatology Research InstituteDallas, Texas  75230
Center For Clinical StudiesHouston, Texas  77030
University Texas M.D. Anderson Cancer CenterHouston, Texas  77030
Virginia Clinical Research, IncNorfolk, Virginia  23507
Dermatology Associates P.L.L.C.Seattle, Washington  98101