Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

October 8, 2025 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Dr. Irina Turchin Pc Inc.
    • Ontario
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Clinic and Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc.
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • København NV, Denmark, 2400
        • Bispebjerg og Frederiksberg Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Frankfurt am Main, Germany, 60596
        • Universitätsklinikum Frankfurt
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel
  • Italy
      • Cagliari, Italy, 09124
        • Ospedale San Giovanni di Dio
      • Roma, Italy, 00133
        • Pol. Universitario Tor Vergata
  • Spain
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska US, Göteborg
      • Stockholm, Sweden, 171 76
        • Karolinska Univ. sjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
12 weeks treatment
Experimental: Spesolimab (low dose)
Drug: Spesolimab (low dose)
12 weeks treatment
Experimental: Spesolimab (high dose)
Drug: Spesolimab (high dose)
12 weeks treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)].
Week 16
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.
From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16
Time Frame: 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
Time Frame: Baseline and 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
Time Frame: 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.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1368-0015
  • 2016-004573-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings