Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP)

SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 140 人开始时间: 2019年5月16日最近更新: 2021年8月10日

适应症

试验速览

暂无简介。

•- 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

•- 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
•- 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.

发起方

SCS Boehringer Ingelheim Comm.V