Palmoplantar Pustulosis MedDRA version: 21.1 Level: PT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: BI 655130
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/m
Sponsors
SCS Boehringer Ingelheim Comm.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 to 75 years of legal age (according to local legislation) at screening. - Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body. - Presence of white or yellow pustules on palms and/or soles at screening and baseline. - Pustular severity score =2 in at least one region and =10 well-demarcated pustules (white or yellow pustules) across all regions at screening and baseline. - PPP PGA of at least moderate severity (=3) at screening and baseline. - A minimum PPP ASI score of 12 at screening and baseline. - Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2). - Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Reduction in PPP ASI total score = 5 from screening visit (Visit 1) to baseline (randomisation visit, Visit 2). - Patients with plaque psoriasis with worsening of plaque psoriasis within the last 3 months prior to screening. - Skin conditions that affect ability to score area and severity of PPP components (such as dyshidrotic eczema, calluses, tinea, xerotic scaling on heels, or maceration of interdigital areas). - Women who are pregnant, nursing, or who plan to become pregnant while in the trial. - Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. - Presence or known history of anti-TNF-induced PPP-like disease. - Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal). - Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.;Secondary Objective: Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.;Primary end point(s): 1) Percent change in PPP ASI from baseline;Timepoint(s) of evaluation of this end point: 1) Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change from baseline in PPP Pain Visual Analog Scale (VAS) score 2) PPP SI change from baseline 3) PPP ASI50 4) PPP ASI75 5) PPP PGA clear/almost clear 6) PPP PGA pustules clear/almost clear 7) Percent change in PPP ASI from baseline ;Timepoint(s) of evaluation of this end point: 1) Weeks 4 and 16 2) Week 16 3) Week 16 4) Week 16 5) Week 16 6) Week 16 7) Week 52 | — |
Countries
Australia, Belgium, Canada, Czechia, Czech Republic, France, Germany, Hungary, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed