Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

The purpose of this study is to determine if the use of ustekinumab, followed by abatacept, will prevent relapse in people with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT01999868

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

108

Starts

2014-03-19

Expected to finish

2018-03-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of plaque psoriasis for at least 6 months
• Baseline Psoriasis Area and Severity Index (PASI) score >= 12
• >=10% body surface area psoriasis involvement
• Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial
• Ability and willingness to provide informed consent and comply with study requirements

You may not qualify if…

• Non-plaque forms of psoriasis
• Grade 2 or 3 moderate to severe psoriatic arthritis not adequately managed with non-steroidal anti-inflammatory drugs (NSAIDs)
• Myocardial infarction, unstable angina, cerebrovascular accident, or other significant cardiovascular event within the previous one year
• Chronic obstructive pulmonary disease (COPD)
• Comorbid condition that requires regular systemic corticosteroid treatment
• History of malignancy, except treated basal cell skin carcinoma
• Treated basal cell skin carcinoma within the previous 5 years
• Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study
• History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections
• Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
• Positive QuantiFERON-TB Gold test. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON-TB Gold test.
• Severe reaction or anaphylaxis to any human monoclonal antibody
• Any previous treatment with agents targeting Interleukin (IL)-12 or IL-23, including ustekinumab
• Any previous treatment with abatacept
• Treatment with biologic agents within previous 3 months, including adalimumab, etanercept, and infliximab
• Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks
• Topical psoriasis treatment within previous 2 weeks, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar
• Investigational study medication within previous 6 months
• Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are >/= 2x the upper limit of normal (ULN).
• Serum creatinine >= 2x the ULN.
• Any of the following hematologic abnormalities, confirmed by repeat test at least 1 week apart:
• White blood count <3,000/μL or >14,000/μL;
• Lymphocyte count <1,000/μL;
• Neutrophil count <1,500/μL;
• Platelet count <150,000 /μL; or

Where it is running

• Dermatology Research Associates — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• Tulane University School of Medicine: Dept. of Dermatology — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• The Rockefeller University — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Case Western University — Cleveland, Ohio, United States
• The University of Utah — Salt Lake City, Utah, United States
• Kirk Barber Research — Calgary, Alberta, Canada
• Innovaderm Research Inc. — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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