Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Psoriasis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135548
• Other study ID #: 1368-0015
• Secondary ID: 2016-004573-40
• Status: Completed
• Phase: Phase 2
• Start date: May 30, 2017
• Est. completion date: November 14, 2018

Study information

• Verified date: November 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 14, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Spesolimab (low dose)
12 weeks treatment
• Placebo
12 weeks treatment
• Spesolimab (high dose)
12 weeks treatment

Locations

Country	Name	City	State
Canada	Dr. Irina Turchin PC Inc.	Fredericton	New Brunswick
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Denmark	Aarhus University Hospital, Skejby	Aarhus
Denmark	Gentofte Hospital	Hellerup
Denmark	Bispebjerg og Frederiksberg Hospital	København NV
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Italy	Ospedale San Giovanni di Dio	Cagliari
Italy	Pol. Universitario Tor Vergata	Roma
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Sweden	Sahlgrenska US, Göteborg	Göteborg
Sweden	Karolinska Univ. sjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Canada,  Denmark,  Germany,  Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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

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