Moderate-to-Severe Plaque Psoriasis MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ixekizumab
Other descriptive name: LY2439821
Concentration unit: mg milligram(s)
Conce
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline (Week 0; Visit 2), as determined by the investigator [2] Patients who are candidates for systemic therapy, and who are naive to systemic treatment for psoriasis. [3] Have a PASI score =10 and BSA =10 at screening (Visit 1) and at baseline (Week 0, Visit 2) [4] Are male or female patients of 18 years or older [5] If a male patient, agree to use a reliable method of birth control during the study and for at least 6 month following the last dose of investigational product. Male patients should not donate sperm during this period. [6] If a female patient of childbearing potential, must test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 15 weeks following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel [7] For non-childbearing potential female patients, patients must be: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), -or- women who are =60 years of age, or- women =40 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 10 Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis 11 Have a history of drug-induced psoriasis 12 Have received systemic nonbiologic psoriasis therapy 13 Have received natalizumab, or other agents targeting a 4 integrin 14 Have received phototherapy within 4 weeks of baseline or have had topical psoriasis treatment within 2 weeks of baseline 15 Exceptions: low potency to mild potency topical steroids will be permitted for use limited to the face, axilla, groin and/or genitalia Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy 16 Have any condition or contraindication as addressed in the local labeling for methotrexate or FAE that would preclude the patient from participating 18 Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study, or have participated in a vaccine clinical study within 12 weeks of baseline 19 Have had a vaccination with BCG within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study 20 Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient 22 Have had any major surgery within 8 weeks of baseline or will require surgery during the study that would pose an unacceptable risk 23 Have active or history of malignant disease within 5 years prior to baseline 24 Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening that pose an unacceptable risk to the patient or of interfering with the interpretation of data 25 Have ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the patient 26 Presence of significant uncontrolled neuropsychiatric disorder, have history of a suicide attempt, have a score of 3 on Item 12 (Thoughts of Death or Suicide) of the QIDS-SR16 at screening or baseline or are clinically judged by the investigator to be at risk for suicide 27 Have evidence or suspicion of active or latent TB 28 Have a known immunodeficiency 29 Are positive for human immunodeficiency virus serology 30 Have evidence of or test positive for HBV by testing positive for anti-hepatitis B core antibody and HBV DNA positive 31 Have evidence of or test positive for hepatitis C virus. 32 Have a body temperature =38°C at baseline, these patients may be re screened (1 time) =4 weeks after documented resolution of elevated temperature. 34 Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer 35 Are women who are planning to become pregnant, who are pregnant, or who are breast feeding 36 Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline; have had a serious bone or joint infection within 24 weeks of baseline, or have ever had an infection of an artificial joint; or are immunocompromised to an extent such that participation in the study would pose an unacceptable risk 37 Have or have had an infection typical of an immunocompromised host and/or that occurs with increased incidence in an immunocompromised host 38 Have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The coprimary objectives of the study are to test whether ixekizumab Q2W/Q4W is superior to FAE and is superior to MTX at Week 24 in the treatment of patients with moderate-to-severe psoriasis who are candidates for systemic therapy as measured by 75% improvement in Psoriasis Area and Severity Index (PASI 75) from baseline assuming, that non-adherent patients are treatment failures.;Secondary Objective: To assess whether ixekizumab is superior to FAE and is superior to MTX over the course of treatment in the treatment of patients with moderate-to-severe psoriasis who are candidates for systemic therapy assuming that non-adherent patients are treatment failures as measured by efficacy outcomes To assess whether ixekizumab is superior to FAE and superior to MTX at all study visits in the treatment of patients with moderate-to-severe psoriasis assuming that non-adherent patients are treatment failures as measured by health outcomes assessments To explore the treatment difference between MTX and FAE with respect to the same outcomes as described above. ;Primary end point(s): LPLV | — |
Countries
Germany
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed