Patients with moderate to severe chronic plaque psoriasis. MedDRA version: 17.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with moderate to severe chronic plaque psoriasis, who have successfully completed the preceding trial, 1311.2. Successful completion of preceding trial is defined as either of the following: a. Completion of the entire follow up period, thus reaching EOS visit. b. Loss of response, defined as decrease in response to =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: -Patients who experienced any drug related Serious Adverse Event in the preceding trial -Patients who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the investigator), during the preceding trial 1311.2 -Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator, would compromise the safety of the patient or the quality of the data -Known clinically important acute or chronic infections including hepatitis, HIV and tuberculosis (including latent tuberculosis), or a positive interferon gamma release assay (IGRA) testing for tuberculosis (if available at visit 1) -Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial 1311.2 (except treated cutaneous squamous cell or basal cell carcinoma or carcinoma in situ of the cervix that have been adequately treated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of BI 655066 during open-label, long-term treatment;Secondary Objective: Assess the long term efficacy BI 655066 in patients with moderate to severe chronic plaque psoriasis.;Primary end point(s): 1: The primary efficacy endpoint is achievement of a greater than or equal to 90% reduction in PASI score from baseline (i.e., achieving PASI 90) at the week 12 visit. Baseline PASI for this study is defined as the baseline PASI for the 1311.2 study. 2: Occurrence of AE 3: Occurrence of drug related AEs 4: Occurrence of SAEs ;Timepoint(s) of evaluation of this end point: 1: 12 Weeks 2: 4.5 years 3: 4.5 years 4: 4.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Achievement of PASI 50 at the week 12 visit: 2: Proportion of patients achieving an sPGA of clear or almost clear 3: Achievement of PASI 75 at the week 12 visit: 4: Achievement of PASI 100at the week 12 visit: ;Timepoint(s) of evaluation of this end point: 1: 12 Weeks 2: 12 Weeks 3: 12 Weeks 4: 12 Weeks | — |
Countries
Canada, Finland, France, Germany, Norway, Sweden, United States
Contacts
Public ContactQRPE pSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH
Outcome results
None listed