A study to test how effective and safe different doses of BI 655130 are in patients with a moderate to severe form of the skin disease Palmoplantar Pustulosis

Phase 1

Conditions: Palmoplantar Pustulosis
MedDRA version: 21.1Level: PTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2018-003078-28-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130<br>compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI<br>at Week 16. The target dose(s) will be estimated from the model by incorporating<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Change from baseline in PPP Pain Visual Analog Scale (VAS) score <br>2) PPP SI change from baseline <br>3) PPP ASI50 <br>4) PPP ASI75 <br>5) PPP PGA clear/almost clear <br>6) PPP PGA pustules clear/almost clear <br>7) Percent change in PPP ASI from baseline <br>;Timepoint(s) of evaluation of this end point: 1) Weeks 4 and 16<br>2) Week 16<br>3) Week 16<br>4) Week 16<br>5) Week 16<br>6) Week 16<br>7) Week 52

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