Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

NCT03135548 | Completed Phase 2 Results DMC

• 2 other identifiers: 1368-00152016-004573-40
• Study Type: interventional
• Target: 59
• Locations: 6 countries
• Sites: 18

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

Spesolimab (low dose)

EXPERIMENTAL

Drug: Spesolimab (low dose)

Spesolimab (high dose)

EXPERIMENTAL

Drug: Spesolimab (high dose)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Spesolimab (low dose) DRUG

12 weeks treatment

Spesolimab (low dose)

Placebo DRUG

12 weeks treatment

Placebo

Spesolimab (high dose) DRUG

12 weeks treatment

Spesolimab (high dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, 18 to 65 years of age at screening.
• Palmoplantar Pustulosis

You may not qualify if:

• Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar Pustulosis (PPP)-like disease.
• Active or latent tuberculosis

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Bispebjerg og Frederiksberg Hospital

København NV, 2400, Denmark

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20537, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Ospedale San Giovanni di Dio

Cagliari, 09124, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Sahlgrenska US, Göteborg

Gothenburg, 413 45, Sweden

Location

Karolinska Univ. sjukhuset

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.

  PMID: 39216969 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: May 30, 2017
• Primary Completion: July 12, 2018
• Study Completion: November 14, 2018
• Last Updated: October 16, 2025
• Results First Posted: November 26, 2019

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); DE (5); SE (2); CA (3); DK (3); IT (2)