Extension trial assessing the safety and efficacy of BI 655066 in patients with moderate to severe chronic plaque psoriasis
- Conditions
- Patients with moderate to severe chronic plaque psoriasis.MedDRA version: 17.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-001687-36-FI
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
-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 - Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
-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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>baseline (i.e., achieving PASI 90) at the week 12 visit. Baseline PASI for this study is defined<br>as the baseline PASI for the 1311.2 study.<br><br>2: Occurrence of AE<br><br><br><br>3: Occurrence of drug related AEs<br><br>4: Occurrence of SAEs<br>;Timepoint(s) of evaluation of this end point: 1: 12 Weeks<br><br>2: 4.5 years<br><br>3: 4.5 years<br><br>4: 4.5 years<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Achievement of PASI 50 at the week 12 visit:<br><br>2: Proportion of patients achieving an sPGA of clear or almost clear<br><br>3: Achievement of PASI 75 at the week 12 visit:<br><br>4: Achievement of PASI 100at the week 12 visit:<br>;Timepoint(s) of evaluation of this end point: 1: 12 Weeks<br><br>2: 12 Weeks<br><br>3: 12 Weeks<br><br>4: 12 Weeks<br>