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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
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): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].
Time frame: Week 16
Number of Participants With Drug-related Adverse Events (AEs)
Number of participants with drug-related AEs are presented.
Time frame: From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
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): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].
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Innovaderm Research Inc.
Montreal, Quebec, Canada
Aarhus University Hospital, Skejby
Aarhus, Denmark
Gentofte Hospital
Hellerup, Denmark
Bispebjerg og Frederiksberg Hospital
København NV, Denmark
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
TFS Trial Form Support GmbH
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
...and 8 more locations
Time frame: 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): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].
Time frame: 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. 1. = Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules. 2. = Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent. 3. =Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved. 4. =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.
Time frame: Week 16