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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

Primary Purpose

Palmoplantar Pustulosis (PPP)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Placebo
Spesolimab
Spesolimab
Spesolimab
Spesolimab
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmoplantar Pustulosis (PPP)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • Wallace Medical Group
  • Therapeutics Clinical Research
  • Advanced Medical Research PC
  • Epiphany Dermatology of Kansas, LLC
  • University of Missouri Health System
  • Washington University School of Medicine
  • Skin Specialists, P.C.
  • The Psoriasis Treatment Center of Central New Jersey
  • Paddington Testing Co., Inc.
  • University of Pittsburgh Medical Center
  • Menter Dermatology Research Institute
  • University of Utah Health
  • Virginia Clinical Research, Inc.
  • Woden Dermatology
  • Westmead Hospital
  • Veracity Clinical Research
  • Skin Health Institute Inc
  • Royal Melbourne Hospital
  • Brussels - UNIV Saint-Luc
  • UZ Leuven
  • CARe Clinic
  • Dr. Irina Turchin PC Inc.
  • SimcoDerm Medical and Surgical Dermatology Centre
  • The Guenther Dermatology Research Centre
  • York Dermatology Clinic and Research Centre
  • K. Papp Clinical Research Inc.
  • Innovaderm Research Inc.
  • CCBR Czech a.s.
  • CCBR Czech Prague s.r.o.
  • Sanatorium Prof. Arenebergera
  • HOP l'Archet
  • HOP Saint-Louis
  • HOP Larrey
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • CRU Hungary Ltd, Private Practice, Miskolc
  • University of Pecs
  • Markusovszky University Teaching Hospital
  • Veszprem County Csolnoky Ferenc Hospital
  • Nagoya City University Hospital
  • Fujita Health University Hospital
  • Tokyo Dental College Ichikawa General Hospital
  • Ehime University Hospital
  • Fukuoka University Hospital
  • Gifu University Hospital
  • Asahikawa Kosei General Hospital
  • Asahikawa Medical University Hospital
  • Takagi Dermatological Clinic
  • Hosui General Medical Clinic
  • Takamatsu Red Cross Hospital
  • Sagamihara National Hospital
  • Kumamoto University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Tohoku University Hospital
  • Shinshu University Hospital
  • Okayama University Hospital
  • University of the Ryukyus Hospital
  • Kindai University Hospital
  • Nakatsu Dermatology Clinic
  • Osaka City University Hospital
  • Osaka University Hospital
  • Shiga University of Medical Science Hospital
  • Jichi Medical University Hospital
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • Tokyo Medical University Hospital
  • Seibo Hospital
  • Shirasaki Dermatology and Neurology Clinic
  • Wakayama Medical University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Amphia Ziekenhuis
  • Barbara Rewerska Diamond Clinic, Krakow
  • Dermoklinika medical center, Lodz
  • Independent Public Clin.Hosp.no1 Lublin
  • Municipal Hospital Complex in Olsztyn
  • Dermmedica Sp. z o.o., Wroclaw
  • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
  • LLC "Medical Center Azbuka Zdorovia"
  • Dermatovenereological Dispensary #10, St. Petersburg
  • National Taiwan University Hospital
  • Royal Devon and Exeter Hospital
  • Guy's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo & Spesolimab

Spesolimab 'Speso Low'

Spesolimab 'Speso Medium-low'

Spesolimab 'Speso Medium-high'

Spesolimab 'Speso High'

Arm Description

Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.

Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.

Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.

Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.

Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.

Outcomes

Primary Outcome Measures

The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline
The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline * 100%. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Secondary Outcome Measures

Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4
Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( | ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16
Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( | ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16
PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)
Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline * 100% >= 50%, PPP ASI50 = 1.
Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)
Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline * 100% >= 75%, PPP ASI75 = 1.
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16
Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components.
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16
Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe.
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline
The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). LS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Full Information

First Posted
July 9, 2019
Last Updated
July 1, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04015518
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
July 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis (PPP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo & Spesolimab
Arm Type
Other
Arm Description
Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.
Arm Title
Spesolimab 'Speso Low'
Arm Type
Experimental
Arm Description
Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.
Arm Title
Spesolimab 'Speso Medium-low'
Arm Type
Experimental
Arm Description
Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.
Arm Title
Spesolimab 'Speso Medium-high'
Arm Type
Experimental
Arm Description
Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.
Arm Title
Spesolimab 'Speso High'
Arm Type
Experimental
Arm Description
Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Primary Outcome Measure Information:
Title
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline
Description
The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline * 100%. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Time Frame
week 0 (baseline) and week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4
Description
Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( | ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Time Frame
week 0 (baseline) and week 4.
Title
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16
Description
Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( | ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Time Frame
week 0 (baseline) and week 16.
Title
Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16
Description
PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Time Frame
week 0 (baseline) and week 16.
Title
Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)
Description
Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline * 100% >= 50%, PPP ASI50 = 1.
Time Frame
week 0 (baseline) and week 16
Title
Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)
Description
Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline * 100% >= 75%, PPP ASI75 = 1.
Time Frame
week 0 (baseline) and week 16
Title
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16
Description
Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components.
Time Frame
week 0 (baseline) and week 16
Title
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16
Description
Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe.
Time Frame
week 0 (baseline) and week 16
Title
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline
Description
The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). LS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
Time Frame
week 0 (baseline) and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Wallace Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Epiphany Dermatology of Kansas, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Skin Specialists, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
The Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Paddington Testing Co., Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Utah Health
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Veracity Clinical Research
City
Wooloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute Inc
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Facility Name
Dr. Irina Turchin PC Inc.
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
York Dermatology Clinic and Research Centre
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
CCBR Czech a.s.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CCBR Czech Prague s.r.o.
City
Prague 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Sanatorium Prof. Arenebergera
City
Prague
ZIP/Postal Code
11000
Country
Czechia
Facility Name
HOP l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
HOP Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
CRU Hungary Ltd, Private Practice, Miskolc
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Markusovszky University Teaching Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Veszprem County Csolnoky Ferenc Hospital
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Nagoya City University Hospital
City
Aichi, Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Fujita Health University Hospital
City
Aichi, Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Tokyo Dental College Ichikawa General Hospital
City
Chiba, Ichikawa
ZIP/Postal Code
272-8513
Country
Japan
Facility Name
Ehime University Hospital
City
Ehime, Toon
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu, Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Asahikawa Kosei General Hospital
City
Hokkaido, Asahikawa
ZIP/Postal Code
078-8211
Country
Japan
Facility Name
Asahikawa Medical University Hospital
City
Hokkaido, Asahikawa
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Takagi Dermatological Clinic
City
Hokkaido, Obihiro
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Hosui General Medical Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
064-0807
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Kagawa, Takamatsu
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Sagamihara National Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto, Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Shinshu University Hospital
City
Nagano, Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
University of the Ryukyus Hospital
City
Okinawa, Nakagami-gun
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osaka-sayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Nakatsu Dermatology Clinic
City
Osaka, Osaka
ZIP/Postal Code
531-0072
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka, Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka, Suita
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Shiga, Otsu
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi, Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo, Itabashi-ku
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Tokyo, Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seibo Hospital
City
Tokyo, Shinjuku
ZIP/Postal Code
161-8521
Country
Japan
Facility Name
Shirasaki Dermatology and Neurology Clinic
City
Toyama, Takaoka
ZIP/Postal Code
933-0871
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama, Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Barbara Rewerska Diamond Clinic, Krakow
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Dermoklinika medical center, Lodz
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Independent Public Clin.Hosp.no1 Lublin
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Municipal Hospital Complex in Olsztyn
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Dermmedica Sp. z o.o., Wroclaw
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
LLC "Medical Center Azbuka Zdorovia"
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Dermatovenereological Dispensary #10, St. Petersburg
City
Saint-Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing 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 https://www.mystudywindow.com/msw/datasharing 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.
IPD Sharing 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.
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 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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://mystudywindow.com
Description
Related Info

Learn more about this trial

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

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