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Trial record 1 of 1 for:    NCT04015518
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A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04015518
Recruitment Status : Active, not recruiting
First Posted : July 11, 2019
Last Update Posted : April 21, 2021
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.

Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

Condition or disease Intervention/treatment Phase
Palmoplantar Pustulosis (PPP) Drug: Spesolimab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : August 6, 2020
Estimated Study Completion Date : August 5, 2021

Arm Intervention/treatment
Experimental: Dose group 1 Drug: Spesolimab
BI 655130

Drug: Placebo

Experimental: Dose group 2 Drug: Spesolimab
BI 655130

Drug: Placebo

Experimental: Dose group 3 Drug: Spesolimab
BI 655130

Drug: Placebo

Experimental: Dose group 4 Drug: Spesolimab
BI 655130

Drug: Placebo

Placebo Comparator: Placebo only Drug: Placebo

Primary Outcome Measures :
  1. Percent change in PPP ASI from baseline [ Time Frame: week 16 ]

Secondary Outcome Measures :
  1. Change from baseline in PPP Pain Visual Analog Scale (VAS) score [ Time Frame: weeks 4 and 16 ]
  2. PPP SI change from baseline [ Time Frame: week 16 ]
  3. PPP ASI50 [ Time Frame: week 16 ]
  4. PPP ASI75 [ Time Frame: week 16 ]
  5. PPP PGA clear/almost clear [ Time Frame: week 16 ]
  6. PPP PGA pustules clear/almost clear [ Time Frame: week 16 ]
  7. Percent change in PPP ASI from baseline [ Time Frame: week 52 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 to 75 years of legal age (according to local legislation) at screening.
  • Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
  • PPP PGA of at least moderate severity (≥3) at screening and baseline.
  • A minimum PPP ASI score of 12 at screening and baseline.
  • Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
  • Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
  • Further criteria apply.

Exclusion Criteria:

  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
  • Presence or known history of anti-TNF-induced PPP-like disease.
  • Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
  • Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Further criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04015518

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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT04015518    
Other Study ID Numbers: 1368-0016
2018-003078-28 ( EudraCT Number )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases