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)

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) - 1368-0016

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48187

Enrollment

Registered

2019-05-07

Start date

2019-10-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmoplantar Pustulosis

Interventions

Approximately 140 eligible patients with Palmoplantar Pustulosis will be randomised in a 2:1:1:1:2 ratio to one of the 5 following treatment arms: Arm 1: BI 655130 Loading Dose 1 = 3000 mg (600 mg at

Maintenance Treatment 600 mg q4w (N=40) Arm 2: BI 655130 Loading Dose 1 = 3000 mg (600 mg at Day 1, W1, W2, W3, and W4)

Maintenance Treatment 300 mg q4w (N=20) Arm 3: BI 655130 Loading Dose 2 = 1500 mg (300 mg at Day 1, W1, W2, W3, and W4)

MaintenanceTreatment 600 mg q4w (N=20) Arm 4: BI 655130 Loading Dose 2 = 1500 mg (300 mg at Day 1, W1, W2, W3, and W4)

Maintenance Treatment 300 mg q4w until W16 (W8, W12, and W16) followed by 300 mg q8w (N=20) Arm 5: Placebo Loading Dose Placebo

Maintenance Treatment Placebo until Week 16 followed by Maintenance Treatment 600 mg q4w starting at Week 16 (N=40) Mode of administration: Subcutaneous injections Trial includes safety lab and uri

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male or female patients, 18 to 75 years of legal age (according to local legislation) at screening (visit 1) * Diagnosed with Palmoplantar Pustulosis with a minimum PPP ASI score of 12 and PPP PGA of at least moderate severity (*3), both at screening (visit 1) and baseline (visit 2) * Presence of white or yellow pustules on palms and/or soles at screening (visit 1) and baseline (visit 2) * Pustular severity score *2 in at least one region and *10 well-demarcated pustules (white or yellow pustules) across all regions at screening (visit 1) and baseline (visit 2)

Exclusion criteria

Exclusion criteria: * Patients with a reduction in PPP ASI total score * 5 from screening (Visit 1) to baseline (Visit 2) are excluded * Patients with plaque psoriasis with worsening of plaque psoriasis within the last 3 months prior to screening.

Design outcomes

Primary

Measure	Time frame
The primary endpoint to assess efficacy of BI 655130 is % change in PPP ASI (Palmoplantar Pustulosis Area and Severity Index) from baseline at Week 16.	—

Secondary

Measure	Time frame
* Change from baseline in Pain Visual Analogue Scale (VAS) score at Week 4 and 16 * PPP SI change from baseline at Week 16 * PPP ASI50 at Week 16 * PPP ASI75 at Week 16 * PPP PGA clear/almost clear at Week 16 * PPP PGA pustules clear/almost clear at Week 16 * Percent change in PPP ASI from baseline at Week 52	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)