Psoriasis MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Anti IL-23 Monoclonal Anitbody
Product Code: SCH 900222
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Anti-Human Interleukin-23 Monoclonal Antibody
Current
Sponsors
Schering-Plough Research Institute, a Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject must meet all the criteria listed below to participate in the trial. 1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, provide written informed consent in accordance with institutional and regulatory guidelines, and, for subjects at US sites, authorization to use protected health information (Health Insurance Portability and Accountability Act [HIPAA]). 2. Subject must be =18 years of age. A subject may be of either sex and of any race/ethnicity. 3. Diagnosis of predominantly plaque psoriasis for =6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator). 4. Subject is considered to be a candidate for phototherapy or systemic therapy. 5. PASI score =12 at Baseline. 6. Psoriasis BSA involvement =10% at Baseline. 7. PGA of at least moderate disease (moderate, marked, or severe) at Baseline. 8. Subject is considered to be eligible according to the following tuberculosis (TB) Screening criteria: a. Has no history of untreated latent or active TB prior to Screening. Prophylactic treatment for latent TB (as per local guidelines) must be initiated at least 4 weeks prior to first administration of study medication. b. Has no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c. Has had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication. d. Within 4 weeks prior to the first administration of study medication, either has negative diagnostic TB test results (defined as a negative tuberculin skin test or a negative QuantiFERON-TB Gold test. e. A subject who has a positive intradermal skin test or positive QuantiFERON gold TB test, or who has had recent close contact with a person with active TB, or has signs or symptoms suggestive of active TB upon medical history and/or physical examination, must have a negative chest CT scan taken within 4 weeks of the first administration of study medication. The scan must be read by a qualified radiologist, and must have no evidence of current active TB or old inactive TB. 9. Subject is unlikely to conceive, as indicated by at least one “yes” answer to the following questions: a. Subject is a male. b. Subject is a surgically sterilized female. c. Subject is a postmenopausal female =45 years of age with >1year since last menses. d. Subject is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity OR use double barrier contraception (ie, condom with spermicide or has a vasectomized partner PLUS oral, intramuscular or implanted contraceptives, diaphragm with spermicide, contraceptive sponge, intrauterine device [IUD]) OR use appropriate double barrier contraception as per local regulations or guidelines. 10. For women of childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to the first dose of study medication. 11. Subject must have results of clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator and medical monitor (or app
Exclusion criteria
Exclusion criteria: A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial: 1. Presence of nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medicationexacerbated psoriasis, or new onset guttate psoriasis. 2. Subject who will require oral or injectable corticosteroids during the trial. 3. Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening. 4. Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. 5. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface antigen, or hepatitis C test result. 6. Prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous call carcinomaof the skin in situ, squamous call carcinoma with no evidence of recurrence within 5 years, or carcinoma in situ of the cervix that has been adequately treated). 7. Subject who has received live virus vaccination within 4 weeks prior to Baseline or who intends to receive live virus vaccination during the trial. 8. Previous exposure to any agents targeting IL-12 and/or IL-23. 9. Subject with prior exposure to two or more TNF antagonists with discontinuation due to lack of efficacy. 10. Subject who is currently participating in another interventional clinical trial or have participated in an interventional clinical trial within 4 weeks prior to Screening. Note: Subjects participating in observational studies or noninterventional registry studies may be included in the study. 11. The subject or a family member is among the personnel of the investigational or sponsor staff directly involved with this trial. 12. Within 6 months prior to Screening, any significant organ dysfunction, including cardiac (see below), renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, psychiatric, ophthalmologic, or metabolic conditions or clinically significant laboratory abnormalities that place the subject at unacceptable risk for participation in a trial of an immunomodulatory therapy in the judgment of the investigator and sponsor. However, if the subject has significant organ dysfunction or exceeds the ranges below, the investigator should confer with the medical monitor (or appropriate designee) regarding study enrollment: a. absolute neutrophil count <1500/mm3 b. platelet count <100,000/mm3 c. hemoglobin <11 g/dL d. creatinine =1.5 x the upper limit of normal (ie, =133 µmol/L) e. alanine transaminase (ALT [SGPT]) or aspartate transaminase (AST [SGOT]) =2.5 x the upper limit of normal 13. History of myocardial infarction, congestive heart failure (New York Heart Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening. 14. Subject who, in the opinion of the investigator, will not be able to participate optimally in the trial. 15. Subject with a history of alcohol or drug abuse in the previous 2 years. 16. Subject who has received any of the medications listed below within the indicated washout period prior to randomiza
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of Part 1 (Weeks 0 to 16) is to evaluate the optimal dose regimen of SCH 900222 to induce PASI 75 response at Week 16 in subjects with moderate-to-severe psoriasis.The primary objective of Part 2 (Weeks 16-52) is to evaluate the optimal dose regimen to maintain PASI 75 response at Week 52. The primary objective of Part 3 (Weeks 52-72) is to assess the duration of effect of SCH 900222 as determined by the time at which the Week 52 improvement from baseline is reduced by > 50% (ie, disease relapse). The primary safety objective is to assess the safety/tolerability of multiple-dose administration of SCH 900222.;Secondary Objective: Assess efficacy as defined by PASI 75 at Week 12. Assess efficacy as defined by PGA at Week 16.;Primary end point(s): 1) Primary Efficacy Endpoint for Part 1: PASI 75 response (ie, proportion of subjects with greater than or equal to 75 % improvement in PASI from Baseline) at week 16. 2) Primary Efficacy Endpoint for Part 2: PASI 75 response at week 52. 3) Primary Efficacy Endpoint for Part 3: the time at which the Week 52 improvement from baseline in PASI score is reduced by greater than 50% in subjects who attain PASI 75 at endpoint of Week 52. Primary Safety Endpoints: 1) Percent of subjects with serious infections, defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring IV antibiotics whether or not reported as a serious event, as per the regulatory definition. 2) Percent of subjects with malignancies 3) Percent of subjects with major cardiovascular adverse events including nonfatal stroke, non-fatal myocardial infarction or cardiovascular death 4) Percent of subjects with injection site reactions. 5) Percent of subjects with drug-related hypersensitivity reactions -Adjudication of major cardiovascular events will be conducted by external panels. Additional CRFs will be used to record more detailed data following occurrence of malignancies | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) PASI 75 response at Week 12. 2) Proportion of subjects with PGA "cleared" or "minimal" at Week 16;Timepoint(s) of evaluation of this end point: 1) Baseline and Week 12 2) Baseline and Week 16 | — |
Countries
Argentina, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Japan, Norway, United Kingdom, United States
Contacts
Public ContactRichard S. Shames, MD
Schering-Plough Research Institute, a Division of Schering Corporation
Outcome results
None listed