Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIa Study to Investigate Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacogenomics of Multiple Intravenous Doses of BI 655130 in Patients With Palmoplantar Pustulosis (PPP)
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 59
- Locations
- 18
- Primary Endpoint
- Number of Participants With Drug-related Adverse Events (AEs)
Overview
Brief Summary
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients, 18 to 65 years of age at screening.
- •Palmoplantar Pustulosis
- •Further inclusion criteria apply
Exclusion Criteria
- •Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar Pustulosis (PPP)-like disease.
- •Active or latent tuberculosis
- •Further exclusion criteria apply
Arms & Interventions
Spesolimab (low dose)
Intervention: Spesolimab (low dose) (Drug)
Spesolimab (high dose)
Intervention: Spesolimab (high dose) (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Drug-related Adverse Events (AEs)
Time Frame: From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
Number of participants with drug-related AEs are presented.
Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16
Time Frame: Week 16
Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].
Secondary Outcomes
- Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16(Week 16)
- Percent Change From Baseline in the ppPASI at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16(Week 16)