Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)
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|ClinicalTrials.gov Identifier: NCT01999868|
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Biological: Ustekinumab Biological: Abatacept Procedure: Placebo for Ustekinumab Drug: Placebo for Abatacept||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Ustekinumab (Anti-IL-12/23) Followed by Abatacept (CTLA4-Ig) for the Treatment of Psoriasis Vulgaris (ITN059AI)|
|Actual Study Start Date :||March 19, 2014|
|Actual Primary Completion Date :||December 7, 2017|
|Actual Study Completion Date :||March 1, 2018|
Experimental: Abatacept 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
Procedure: Placebo for Ustekinumab
The abatacept treatment group will also receive subcutaneous placebo for ustekinumab (sterile normal saline) at week 16 and week 28, corresponding to the ustekinumab dosing regimen.
Other Name: Ustekinumab Placebo
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.
Drug: Placebo for Abatacept
The ustekinumab treatment group will also receive weekly subcutaneous injections of placebo for abatacept from week 12 to week 39, corresponding to the abatacept dosing regimen.
Other Name: Abatacept Placebo
- The proportion of participants who experience a psoriasis relapse at any time between week 12 and week 88 [ Time Frame: Week 88 ]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 ]
- The proportion of participants who experience a psoriasis disease relapse between week 28 and week 88 [ Time Frame: Week 88 ]
- The proportion of participants who experience a psoriasis disease relapse between week 40 and week 88 [ Time Frame: Week 88 ]
- Mean length of time after week 12 to psoriasis relapse [ Time Frame: Week 88 ]
- Physician's Global Assessment (PGA) of cleared or minimal at week 40 and week 88 [ Time Frame: Week 88 ]
- Dermatology Life Quality Index (DLQI) [ Time Frame: Weeks 40 and 88 ]
- Frequency and severity of all AEs and SAEs [ Time Frame: Week 88 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999868
|United States, California|
|Dermatology Research Associates|
|Los Angeles, California, United States, 90045|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Louisiana|
|Tulane University School of Medicine: Dept. of Dermatology|
|New Orleans, Louisiana, United States, 70112|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27104|
|United States, Ohio|
|Case Western University|
|Cleveland, Ohio, United States, 44106|
|United States, Utah|
|The University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Kirk Barber Research|
|Calgary, Alberta, Canada, T2G 1B1|
|Innovaderm Research Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Principal Investigator:||James Krueger, MD, PhD||The Rockefeller University|