inflammatory psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: HuMax-Inflam
Product Code: HuMax-Inflam
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: 887116-46-3
Current Sponsor code: HuMax-Inflam
Other descriptive
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with inflammatory, progressive psoriasis vulgaris 2) Man or woman =18 years of age 3) Development of psoriasis on tape-stripped skin within 3 weeks (Koebner-positive patients) 4) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study-related activity is carried out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) A diagnosis of pustular psoriasis 2) Koebner-negative patients 3) Patients previously treated with HuMax-Inflam 4) Treatment with systemic antipsoriatic drugs: etretinate, methotrexate, salazopyrine or cyclosporine =4 weeks prior to treatment start 5) Local treatment with antipsoriatic drugs and UV radiation within 20 cm of the injection area =2 weeks before treatment start 6) Primary or secondary immunodeficiency 7) Active autoimmune disease requiring treatment (in addition to psoriasis vulgaris) 8) Psoriatic rheumatism requiring systemic treatment except for Non-Steroid Antiinflammatoryr Drugs (NSAIDs) 9) Previous or current malignant disease except: a Cervix carcinoma Stage 1B or lower b Noninvasive basal cell carcinoma c Malignant melanoma with a complete response duration of more than 10 years d Other cancer diagnoses with a complete response duration of more than 5 years 10) Chronic or active infections such as (but not limited to) chronic kidney infection, chronic pulmonary infection with bronchial ectasia, rhinitis, and tuberculosis 11) Clinically significant heart disease including unstable angina, acute myocardial infarction within 6 months of Visit 1, heart failure, and arrhythmias requiring treatment except for extrasystoles and minor conductivity anomalies 12) Significant treatment requiring disease; disease conditions of (but not limited to) the kidneys, liver, hematological conditions, gastrointestinal tract, endocrine system, lungs, nervous system – including cerebral conditions, or mental disease 13) Previous significant cerebrovascular disease 14) Known or suspected HIV seropositive status 15) Known or suspected hepatitis B or hepatitis C 16) Laboratory values at screening: Hemoglobin 2 times the upper normal limit S- ALP >2 times the upper normal limit S-creatinine >133 µmol/L 17) Known or suspected sensitivity to the ingredients in the investigational product 18) Patients who have been treated with any non-marketed drug within 4 weeks of Visit 1 19) Concurrent participation in any other clinical trial 20) Patients who are known to be or suspected of being incapable of complying with the study protocol (for example, due to alcoholism, substance abuse or psychiatric illness) 21) Women who breast feed or women with a positive pregnancy test at Visit 1 22) Women of reproductive potential who are not willing to use a contraceptive, defined as oral contraceptive or a coil during the study or 3 months after the final HuMax-Inflam injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to investigate whether treatment with HuMax-Inflam induces regression or reduces progression of inflammatory, progressive psoriasis in comparison with isotonic saline solution.;Secondary Objective: ;Primary end point(s): The Investigator’s overall assessment of disease activity in the treated areas. | — |
Countries
Denmark
Outcome results
None listed