Psoriasis
Conditions
Brief summary
Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.
Interventions
BIOLOGICALInfliximab
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older, either gender, and any race. * Psoriasis affecting \>=5% of body surface, PASI score \>=10 (maximum score 72). * History of plaque psoriasis for \>6 months. * Informed written consent. * Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa \[PUVA\], or systemic therapy). * Negative chest x-ray and purified protein derivative (PPD) within 1 month. * Understand and be able to adhere to dosing and visit schedules. * Screening laboratory tests must meet protocol-specified criteria. * Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.
Exclusion criteria
* Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment. * Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb \[UVB\], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins. * Received previous immunobiologics. * Have HIV, hepatitis B or C. * Recently transplanted (exception - corneal transplant \>3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence). * Concurrent medications that are not permitted. * congestive heart failure (CHF) * Use of cyclosporine or tacrolimus within 4 weeks prior to Screening. * Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening. * Treatment with any investigational drug within 3 months prior to Screening. * Allergy to murine proteins. * Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months. * History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening. * Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease. * Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk. * History of current alcohol or drug abuse. * Not observed designated washout periods for any of the prohibited medications in protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 | 10 weeks | PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab 5 mg/kg Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Infliximab 5 mg/kg |
|---|---|
| Age, Continuous | 37.05 years STANDARD_DEVIATION 13.15 |
| Region of Enrollment Middle East | 22 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab 5 mg/kg | Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 | 16 participants |