Trial record 3 of 21 for:    Ustekinumab | Open Studies

Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01999868
First received: November 26, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.

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 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.


Condition Intervention Phase
Psoriasis
Biological: Ustekinumab
Biological: Abatacept
Drug: Placebo for Ustekinumab
Drug: Placebo for Abatecept
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ustekinumab (Anti-IL-12/23) Followed by Abatacept (CTLA4-Ig) for the Treatment of Psoriasis Vulgaris (ITN059AI)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The proportion of participants who experience a psoriasis relapse at any time between week 12 and week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Psoriasis relapse is defined as loss of > 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 12. The primary endpoint will be assessed in all randomized participants.


Secondary Outcome Measures:
  • The proportion of randomized participants who experience a psoriasis disease relapse prior to week 40. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
  • The proportion of participants who experience a psoriasis disease relapse between week 28 and week 88. [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
  • The proportion of participants who experience a psoriasis disease relapse between week 40 and week 88. [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
  • Mean length of time after week 12 to psoriasis relapse. [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment (PGA) of cleared or minimal at week 40 and week 88. [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) [ Time Frame: Weeks 40 and 88 ] [ Designated as safety issue: No ]
  • Frequency and severity of all AEs and SAEs. [ Time Frame: Week 88 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abatecept Treatment After Removal of Ustekinumab
Subjects in this arm receive abatacept subcutaneous injections of 125 mg, from week 12 to week 39. The abatacept treatment group will also receive subcutaneous ustekinumab placebo at week 16 and week 28, corresponding to the ustekinumab dosing regimen.
Biological: Abatacept

Abatacept (one form of the protein called CTLA4-Ig) interacts with the immune system, reducing the activity of T-cells and may prevent relapse. Orencia™ is the trade name for abatacept, and it is approved by the FDA to treat rheumatoid arthritis in adults.

Dose:

125 mg sub-cutaneous injection

Other Name: orencia
Drug: Placebo for Ustekinumab
Active Comparator: Continued Ustekinumab
The continued ustekinumab treatment group will receive subcutaneous injections of 45 mg ustekinumab (< 100 kg) or 90 mg ustekinumab (> 100 kg) at week 16 and week 28. The ustekinumab treatment group will also receive weekly subcutaneous injections of abatacept placebo from week 12 to week 39, corresponding to the abatacept dosing regimen.
Biological: Ustekinumab

Ustekinumab interferes with the actions of proteins, interleukin 12 (IL12) and interleukin 23 (IL23), which reduces inflammation (swelling) in the skin. Stelara™ is the trade name for ustekinumab and is approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis.

Dose:

Participants who weigh < 100 kg at study entry will receive 45 mg of ustekinumab.

Participants who weigh > 100 kg at study entry will receive 90 mg of ustekinumab.

Other Name: Stelara
Drug: Placebo for Abatecept

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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 vaccines one year prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999868

Locations
United States, California
Dermatology Research Associates Not yet recruiting
Los Angeles, California, United States, 90045
Contact: Emily Stekol    310-337-7171    estekol@drsofen.com   
Principal Investigator: Howard Sofen, MD         
United States, Illinois
University of Michigan Not yet recruiting
Ann Arbor, Illinois, United States, 48109
Contact: Kathryn Keely    734-936-4075    ktkeeley@umich.edu   
Principal Investigator: Y. Helfrich, MD         
Northwestern Medical Faculty Foundation Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Ann Laumann, MD         
United States, Missouri
Central Dermatology Not yet recruiting
St. Louis, Missouri, United States, 63117
Contact: Patrick Behnke    314-721-5565    patrick@centralderm.com   
Principal Investigator: C. Leonardi, MD         
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Mary Sullivan -Whalen       whalems@mail.rockefeller.edu   
Principal Investigator: James Krueger, MD         
Mount Sinai School of Medicine Not yet recruiting
New York, New York, United States, 10029
Contact: Matthew Gagliotti       Matthew.Gagliotti@mssm.edu   
Principal Investigator: Mark Lebwohl, MD         
United States, Texas
Menter Dermatology Research Institute Not yet recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Alan Mentor, MD         
Sub-Investigator: Ryan Caitroina, MD         
United States, Utah
The University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Melissa Weidner       melissa.weidner@hsc.utah.edu   
Principal Investigator: Gerald Krueger, MD         
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 0A2
Contact: Denise Teas       denise.teas@hotmail.com   
Principal Investigator: Richard Langley, MD         
Canada, Quebec
Innovaderm Research Inc. Not yet recruiting
Montreal, Quebec, Canada, H2K 4L5
Contact: Patricia Diaz    514-521-3111    pdiaz@innovaderm.ca   
Principal Investigator: Robert Bissonnette, MD         
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Investigators
Principal Investigator: James Krueger, MD, PhD The Rockefeller University
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01999868     History of Changes
Other Study ID Numbers: DAIT ITN059AI
Study First Received: November 26, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014