Moderate to Severe Chronic Plaque Psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged = 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Active inflammatory diseases other than psoriasis that might confound trial evaluations. 2. Previous treatment with more than 1 biological agent, or adalimumab or adalimumab Biosimilar. No prior biologic exposure within last 6 months of screening will be permitted. 3. significant disease other than psoriasis and/or a significant uncontrolled Disease. 4. Major surgery performed within 12 weeks prior to randomization or planned within 6 months after screening. 5. documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. 6. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. 7. Currently enrolled in another investigational device or drug study. 8. Chronic alcohol or drug abuse. 9. Women who are pregnant, nursing, or who plan to become pregnant during the study or within 6 months following completion or discontinuation from trial. 10. Forms of psoriasis other than chronic plaque psoriasis. Drug-induced psoriasis. 11. Primary or secondary immunodeficiency, including known history of HIV infection or a positive HIV test at screening. 12. Known chronic or relevant acute tuberculosis. 13. Known clinically significant coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure or interstitial lung disease observed on chest X-ray. 14. History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients. 15. Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV). 16. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit; patients who are expecting to receive any live/attenuated virus or bacterial vaccinations during the trial or up to 3 months after the last dose of trial drug. 17. Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial. 18. Known active infection of any kind (excluding fungal infections of nail beds), any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti-infectives within 4 weeks of the Screening or completion of oral anti-infectives within 2 weeks of the Screening Visit. 19. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) at Screening. 20. Hemoglobin < 8.0 g/dL at Screening. 21. Platelets < 100,000/µL at Screening. 22. Leukocyte count < 4000/µL at Screening. 23. Creatinine clearance < 60 mL/min/1.73 m2 at Screening. 24. Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate equivalence in efficacy between BI 695501 and US-licensed Humira® at Week 16 in patients with active moderate to severe chronic plaque psoriasis.;Secondary Objective: To compare the safety and efficacy profiles of BI 695501 and US-licensed Humira. ;Primary end point(s): Proportion of patients with a 75% reduction in Psoriasis Area and Severity Index (PASI 75);Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: • Proportion of patients with a PASI 75 response • Mean percentage improvement in PASI • Proportion of patients with a sPGA = 1 (clear or almost clear) • Proportion of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 Safety endpoint: • Proportion of patients with drug-related AEs;Timepoint(s) of evaluation of this end point: Efficacy endpoints: • Proportion of patients with a PASI 75 response at Week 24 • Mean percentage improvement in PASI at Week 16 • Proportion of patients with a sPGA = 1 (clear or almost clear) at Week 16 • Proportion of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 Safety endpoint: • Proportion of patients with drug-related AEs (for the duration of the study) | — |
Countries
Czech Republic, European Union, Germany, Poland, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed