moderate to severe chronic plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Code: BI 695501
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: not available
Current Sponsor code: BI 695501
Concentration unit: mg/ml milligram(s)/mill
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 48
Exclusion criteria
Exclusion criteria: 1. Active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to Investigator's judgment. 2. Prior exposure to any biologic therapies for any auto-immune diseases (eg: RA, Psoriasis, Crohns Disease, etc). 3. Patients with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders). A significant disease is defined as a disease which, in the opinion of the Investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial. 4. Major surgery (major according to the Investigator's assessment) performed within 12 weeks before enrollment or planned within 6 months after screening, e.g., total hip replacement. 5. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated (in the opinion of the Investigator) 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 trial, or less than 30 days (or less than 5 half-lives, whichever is longer) since ending another investigational device or drug trial(s), or receiving other investigational treatment(s). 8. Chronic alcohol or drug abuse or any condition that, in the Investigator's opinion, makes the patient an unreliable trial subject or unlikely to complete the trial. 9. Women who are pregnant, nursing, or who plan to become pregnant during the course of this trial or within the period at least 6 months following completion or discontinuation from the trial medication. 10. Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g., beta blockers or lithium). 11. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection or a positive HIV test at screening (per the Investigator discretion and where mandated by local authorities). 12. Known chronic or relevant acute TB; IGRA TB test or PPD skin test will be performed according to the labelling for Humira®. If the result is positive, patients may participate in the trial if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If latent TB is confirmed, then treatment must have been initiated before treatment in the study and continued according to local country guidelines. 13. Known clinically significant (per Investigator opinion) coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure (New York Heart Association Classes III or IV) or interstitial lung disease observed on chest X-ray. 14. Patients with a history of any clinically significant adverse reaction (including serious allergic reactions, or anaphylactic reaction, or hypersensitivity) to murine or chimeric proteins, previously used biological drug or its excipients, or natural rubber and latex. 15. Positive serology for HBV or HCV. 16. Rec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetic (PK) similarity between patients receiving United States (US)-licensed Humira® continuously vs those who switch between BI 695501 and US-licensed Humira®, in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: To descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving US-licensed Humira® continuously vs those who switch between BI 695501 and US-licensed Humira®.;Primary end point(s): 1)AUCt, 30-32 (Area under the adalimumab plasma concentration-time curve [AUC] over the dosing interval of Week 30-32) 2)Cmax, 30-32 (Maximum observed adalimumab plasma concentration during the dosing interval Week 30-32);Timepoint(s) of evaluation of this end point: 1) and 2) visits 17 and 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic 1)Cmin, 30-32 (Minimum observed adalimumab plasma concentration during the dosing interval Week 30-32) 2) tmax, 30-32 (Time to maximum observed adalimumab plasma concentration during the dosing interval Week 30-32) Efficacy 3) Proportion of patients with a PASI75 response at Week 32 4) Proportion of patients with an Static Physician’s Global Assessment (sPGA) = 1 (clear or almost clear) at Week 32 Immunogenicity 5) Proportion of patients with ADAs at Week 32 6) ADA titer of patients with ADAs at Week 32 7)Proportion of patients with neutralizing antibody (nAb) frequency and titer at Week 32 Safety 8)Proportion of patients with drug-related AEs during the treatment phase and the safety follow-up period;Timepoint(s) of evaluation of this end point: 1) and 2) visits 17 and 18 (weeks 30-32) 3) and 4) visits: 1,2,4,6,9,11,13,16,18 5) 6) and 7)visits: 2,3,6,8,9,11,13,17,18 8) all the visits from visit 2 to visit 28 (week 58) | — |
Countries
Australia, Chile, Germany, Hungary, Latvia, Mexico, New Zealand, Poland, Russian Federation, South Africa, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed