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

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Ustekinumab — BIOLOGICAL
  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 — BIOLOGICAL
  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
• UST Placebo — DRUG
  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.
• ABA Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 19, 2014

Status verified

Dec 2018

Primary completion

Dec 7, 2017

Completion

Mar 1, 2018

Study Design

Enrollment

108 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: UST, ABA/UST Placebo
  Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and were then randomized to receive blinded (masked) treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
• Active Comparator: UST, UST/ABA Placebo
  Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and were then randomized to receive blinded (masked) treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.

Primary Outcome Measure

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse) [ Time Frame: Post-randomization (Week 12 to 88) ]

Locations (8)

Find similar trials in Los Angeles, CA

Related Studies

• Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
  Recruiting · University of California, San Diego · La Jolla, California
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
  PHASE4 · Recruiting · Bausch Health Americas, Inc. · Fountain Valley, California
• Skin Microbial Ecology in Atopic Dermatitis
  Recruiting · University of Rochester · Rochester, New York