Phase 2
Completed N=108
Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT01999868 ↗Enrolled (actual)
108
Serious AEs
4.5%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse) — 91.1; 87.0; 55.6; 30.4 percentage of participants — p=0.41
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse) |
91.1; 87.0; 55.6; 30.4; 88.9; 84.2 | 0.41 |
| SECONDARY Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse) |
75.6; 52.2; 42.2; 10.9; 83.3; 60.5 | 0.019 sig |
| SECONDARY Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status) |
89.5; 80.0; 48.7; 13.5; 88.2; 79.3 | 0.16 |
| SECONDARY Time to Psoriasis Relapse (Treating Drop-Outs as Relapse) |
28; 40 | 0.06 |
| SECONDARY Time to Psoriasis Relapse (Treating Drop-Outs as Censored) |
28; 48 | 0.005 sig |
| SECONDARY Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA) |
26.9; 58.8; 75.0; 50.0 | 0.013 sig |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) |
2.2; 0.6; -4.3; 0.0 | 0.18 |
| SECONDARY Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase) |
30; 2; 0; 0; 28; 2 | — |
| SECONDARY Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase) |
51; 2; 0; 0; 47; 2 | — |
| SECONDARY Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization) |
28; 22; 2; 5; 0; 0 | — |
| SECONDARY Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization) |
59; 59; 2; 9; 0; 0 | — |
Eligibility 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 (COPD)
- 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:
- White blood count 14,000/μL;
- Lymphocyte count <1,000/μL;
- Neutrophil count <1,500/μL;
- Platelet count <150,000 /μL; or
- 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 (Bacillus Calmette-Guérin) vaccine one year prior to enrollment
Data sourced from ClinicalTrials.gov (NCT01999868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.