Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Ustekinumab; Abatacept; UST Placebo; ABA Placebo
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 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.; 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; 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.; 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 intervention name(s): anti-IL-12/23; Stelara; CTLA4-Ig; cytotoxic T lymphocyte antigen immunoglobulin fusion protein; Orencia; Placebo for Ustekinumab; Ustekinumab Placebo; Placebo for Abatacept; Abatacept Placebo
Intervention MeSH terms: Abatacept; Ustekinumab; Immunoglobulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis vulgaris; ustekinumab; abatacept