Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)
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.
Drug: Placebo for Ustekinumab
Drug: Placebo for Abatecept
|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)|
- 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.
- 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 ]
|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)|
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.
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.
125 mg sub-cutaneous injection
Other Name: orenciaDrug: 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.
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.
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: StelaraDrug: Placebo for Abatecept
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999868
|United States, California|
|Dermatology Research Associates||Not yet recruiting|
|Los Angeles, California, United States, 90045|
|Contact: Emily Stekol 310-337-7171 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: C. Leonardi, MD|
|United States, New York|
|The Rockefeller University||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mary Sullivan -Whalen email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Richard Langley, MD|
|Innovaderm Research Inc.||Not yet recruiting|
|Montreal, Quebec, Canada, H2K 4L5|
|Contact: Patricia Diaz 514-521-3111 firstname.lastname@example.org|
|Principal Investigator: Robert Bissonnette, MD|
|Principal Investigator:||James Krueger, MD, PhD||The Rockefeller University|