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A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Primary Purpose

Palmoplantar Pustulosis

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

About this trial

This is an interventional treatment trial for Palmoplantar Pustulosis

Eligibility Criteria

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

Inclusion Criteria:

  • Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
  • Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
  • Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
  • Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

Exclusion Criteria:

  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Patients who experienced study treatment-limiting adverse events during the parent trial
  • Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
  • Patients with congestive heart disease, as assessed by the investigator
  • Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening in parent trial) 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 (e.g. splenomegaly)
  • Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
  • Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
  • Further exclusion criteria apply

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • University of Missouri Health System
  • The Psoriasis Treatment Center of Central New Jersey
  • University of Pittsburgh Medical Center
  • Menter Dermatology Research Institute
  • University of Utah Health
  • Paratus Clinical Research Woden
  • Westmead Hospital
  • Skin Health Institute Inc
  • Royal Melbourne Hospital
  • Brussels - UNIV Saint-Luc
  • UZ Leuven
  • Dr. Irina Turchin PC Inc.
  • SimcoDerm Medical and Surgical Dermatology Centre
  • The Guenther Dermatology Research Centre
  • Innovaderm Research Inc.
  • CCBR Czech a.s.
  • Sanatorium Prof. Arenebergera
  • Univ. Hospital Kralovske Vinohrady
  • HOP l'Archet
  • HOP Saint-Louis
  • HOP Larrey
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • University of Pecs
  • Markusovszky University Teaching Hospital
  • Fujita Health University Hospital
  • Tokyo Dental College Ichikawa General Hospital
  • Fukuoka University Hospital
  • Gifu University Hospital
  • Asahikawa Medical University Hospital
  • Takagi Dermatological 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
  • Nakatsu Dermatology Clinic
  • Osaka Metropolitan 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
  • Wakayama Medical University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • 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 Type

Experimental

Arm Label

Treatment group

Arm Description

Up to 260 weeks

Outcomes

Primary Outcome Measures

Occurrence of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial
Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial
Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear)

Full Information

First Posted
July 28, 2020
Last Updated
October 2, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04493424
Brief Title
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Official Title
An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
May 15, 2023 (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
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Up to 260 weeks
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Spesolimab
Primary Outcome Measure Information:
Title
Occurrence of treatment emergent adverse events (TEAEs)
Time Frame
Up to week 260
Secondary Outcome Measure Information:
Title
Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial
Time Frame
Up to week 260
Title
Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial
Time Frame
Up to week 260
Title
Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear)
Time Frame
Up to week 260

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly Exclusion Criteria: Women who are pregnant, nursing, or who plan to become pregnant while in the trial Patients who experienced study treatment-limiting adverse events during the parent trial Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof Patients with congestive heart disease, as assessed by the investigator Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening in parent trial) 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 (e.g. splenomegaly) Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix Patients who have developed active or severe infective disease and opportunistic infections/infective diseases Further exclusion 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
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
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
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
Paratus Clinical Research Woden
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
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
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
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
Sanatorium Prof. Arenebergera
City
Prague
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Univ. Hospital Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
HOP l'Archet
City
Nice
ZIP/Postal Code
06200
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
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
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
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 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
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
Nakatsu Dermatology Clinic
City
Osaka, Osaka
ZIP/Postal Code
531-0071
Country
Japan
Facility Name
Osaka Metropolitan 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
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
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 Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

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