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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

NCT03135548 BI 655130.

Methods Double‐blind, randomised, placebo‐controlled, phase IIa study
Multi‐centre
Period of inclusion: starting 30 May 2017
Participants Inclusion criteria of the trial
  • Male or female patients, 18 to 65 years of age at screening

  • Palmoplantar pustulosis

  • Further inclusion criteria apply


Exclusion criteria of the trial
  • Presence or known history of anti‐tumour necrosis factor (TNF)‐induced palmoplantar pustulosis (PPP)‐like disease

  • Active or latent tuberculosis

  • Further exclusion criteria apply

Interventions Intervention 1
A: BI 655130 (low‐dose) 12 weeks of treatment
Intervention 2
B: Placebo 12 weeks of treatment
Intervention 3
C: BI 655130 (high‐dose) 12 weeks of treatment
Outcomes Primary outcomes of the trial
  • Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) 50 at week 16 (time frame: week 16)

  • Number of patients with drug‐related adverse events (AEs) (time frame: up to 32 weeks)


Secondary outcomes of the trial
  • Treatment success defined as achieving a clinical response of 0 or 1 = clear/almost clear via Palmoplantar Pustulosis Physicians Global Assessment (PPPGA) at week 16 (time frame: week 16)

  • Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) 75 at week 16 (time frame: week 16)

  • Percentage change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) at week 16 (time frame: baseline and week 16)

Notes Sponsor: Boehringer Ingelheim

AE: adverse event.

PPP: palmoplantar pustulosis.

ppPASI: Palmoplantar Pustular Psoriasis Area and Severity Index.

PPPGA: Palmoplantar Pustulosis Physicians Global Assessment.

PUVA: combination of psoralens and long‐wave ultraviolet radiation.

RCT: randomised controlled trial.

TNF: tumour necrosis factor.