Palmoplantar Pustulosis MedDRA version: 21.1 Level: PT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial - Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation - Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial. - Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in Section 4.2.3 and in the patient information. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 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: - Women who are pregnant, nursing, or who plan to become pregnant while in the trial. - Patients who experienced study treatment-limiting adverse events during the parent trial. - Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. - Patients with congestive heart disease, as assessed by the investigator. - Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening in parent trial) 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 (e.g. splenomegaly). - Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. - Patients who have developed active or severe infective disease and opportunistic infections/infective diseases. -- Patients with latent TB during preceding trial are allowed to be included in study 1368-0024, provided they have received and/or receive currently appropriate treatment according to local guidelines. - Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and efficacy of Spesolimab (BI 655130) in patients with PPP, who have completed previous Spesolimab (BI 655130) trials and are qualified for entry in this trial.;Secondary Objective: Supportive efficacy assessments will also be done on pre-specified secondary endpoints.;Primary end point(s): 1) occurrence of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: 1) up to 260 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percent change in PPP ASI from baseline in parent trial 2) Proportion of patients with PPP ASI50 compared to baseline in parent trial 3) Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear);Timepoint(s) of evaluation of this end point: 1) week 48, 96, 144, 192, 240 and 260 2) week 48, 96, 144, 192, 240 and 260 3) week 48, 96, 144, 192, 240 and 260 | — |
Countries
Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH&Co KG
Outcome results
None listed