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-GB

Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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: 0
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 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 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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