Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Spesolimab (low dose)
* Drug: Placebo
* Drug: Spesolimab (high dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spesolimab (low dose)<br> | Drug: Spesolimab (low dose)<br>* 12 weeks treatment<br>|
| Experimental: Spesolimab (high dose)<br> | Drug: Spesolimab (high dose)<br>* 12 weeks treatment<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 12 weeks treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at 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)]. | Week 16 | 
| Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related AEs are presented. | From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Percentage of participants who achieved >75% reduction in ppPASI score was assessed by ppPASI75. 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)]. | Week 16 | 
| Percent Change From Baseline in the ppPASI at Week 16 | The percentage change in the ppPASI score from Baseline to Week 16 was measured. 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)]. | 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 | pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains. = Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules. = Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent. =Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved. =Severe = Severe scaling and/or erythema and / or crusting; numerous new (yellow) or old (brown) pustules with and/or without major conflence covering the entire area of at least 2 palmoplantar surfaces. | Week 16 |