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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Ustekinumab (Biological); Abatacept (Biological); Placebo for Ustekinumab (Procedure); Placebo for Abatacept (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
James Krueger, MD, PhD, Principal Investigator, Affiliation: The Rockefeller University

Summary

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.

Clinical Details

Official title: Efficacy of Ustekinumab (Anti-IL-12/23) Followed by Abatacept (CTLA4-Ig) for the Treatment of Psoriasis Vulgaris (ITN059AI)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of participants who experience a psoriasis relapse at any time between week 12 and week 88

Secondary outcome:

The proportion of randomized participants who experience a psoriasis disease relapse prior to week 40

The proportion of participants who experience a psoriasis disease relapse between week 28 and week 88

The proportion of participants who experience a psoriasis disease relapse between week 40 and week 88

Mean length of time after week 12 to psoriasis relapse

Physician's Global Assessment (PGA) of cleared or minimal at week 40 and week 88

Dermatology Life Quality Index (DLQI)

Frequency and severity of all AEs and SAEs

Detailed description: Psoriasis is a chronic immune disease of the skin and joints that affects about 2% of the population. The most common form of psoriasis is plaque psoriasis, also called psoriasis vulgaris. A variety of drugs, including biologics, are available for treatment of moderate to severe psoriasis. When biologic agents are stopped, psoriasis can return (relapse) and often requires the biologic to be restarted and continued. No treatment program has been identified to prevent relapse of psoriasis. The study design has a lead-in period of weight-based ustekinumab treatment, with all participants receiving either 45 mg ustekinumab (<= 100 kg) or 90 mg ustekinumab (> 100 kg) administered subcutaneously at weeks 0 and 4. At week 12, participants will be assessed for a Psoriasis Area and Severity Index (PASI) 75 response to ustekinumab. Participants who do not achieve a PASI 75 score will be discontinued from the investigation and permitted to seek standard therapy.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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: 1. White blood count <3,000/μL or >14,000/μL; 2. Lymphocyte count <1,000/μL; 3. Neutrophil count <1,500/μL; 4. Platelet count <150,000 /μL; or 5. Hemoglobin <10 g/dL.

- Females who are pregnant, lactating, planning on pregnancy during the study period,

or unwilling to use FDA-approved method of birth control

- Receipt of a live vaccine (e. g., varicella, measles, mumps, rubella, cold-attenuated

intranasal influenza vaccine, and smallpox) in the 6 weeks before enrollment

- BCG (Bacillus Calmette-Guérin) vaccine one year prior to enrollment

Locations and Contacts

Dermatology Research Associates, Los Angeles, California 90045, United States; Recruiting
Clara Bieck, Phone: 310-337-7171, Email: cbieck@drsofen.com
Howard Sofen, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Tina Kiguradze, MD, Phone: 312-695-4625, Email: tinatin.kiguradze@northwestern.edu
Ann Laumann, MD, Principal Investigator

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Kathryn Keely, Phone: 734-936-4075, Email: ktkeeley@umich.edu
Y. Helfrich, MD, Principal Investigator

Central Dermatology, St. Louis, Missouri 63117, United States; Withdrawn

Mount Sinai School of Medicine, New York, New York 10029, United States; Withdrawn

The Rockefeller University, New York, New York 10065, United States; Recruiting
Mary Sullivan -Whalen, Email: whalems@mail.rockefeller.edu
James Krueger, MD, Principal Investigator

Wake Forest University, Winston-Salem, North Carolina 27104, United States; Recruiting
Judy Holbrook, Phone: 336-716-8991, Email: jholbroo@wakehealth.edu
Steven Feldman, M.D., Ph.D., Principal Investigator

Eastern Canada Cutaneous Research Associates, Halifax, Nova Scotia B3H 0A2, Canada; Withdrawn

Case Western University, Cleveland, Ohio 44106, United States; Recruiting
Jennie Pexa, Phone: 216-983-0879, Email: Jennie.Pexa@Uhhospitals.org
Neil Korman, M.D., Ph.D., Principal Investigator

Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada; Recruiting
Sarah Bezzaoucha, Phone: 514-521-3111, Ext: 244, Email: sbezzaouacha@innovaderm.ca
Robert Bissonnette, MD, Principal Investigator

Menter Dermatology Research Institute, Dallas, Texas 75246, United States; Withdrawn

The University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Melissa Weidner, Email: melissa.weidner@hsc.utah.edu
Gerald Krueger, MD, Principal Investigator

Additional Information

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network Web site

Starting date: February 2014
Last updated: June 15, 2015

Page last updated: August 23, 2015

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