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

An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials

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.

Study Overview

• Status: Terminated
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Drug: Spesolimab

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Paratus Clinical Research Woden
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Brussels - UNIV Saint-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• Czechia
  • Pardubice, Czechia, 530 02
    • CCBR Czech a.s.
  • Prague, Czechia, 11000
    • Sanatorium Prof. Arenebergera
  • Praha, Czechia, 100 34
    • Univ. Hospital Kralovske Vinohrady
• France
  • Nice, France, 06200
    • HOP l'Archet
  • Paris, France, 75010
    • HOP Saint-Louis
  • Toulouse, France, 31059
    • HOP Larrey
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Frankfurt am Main, Germany, 60596
    • Universitätsklinikum Frankfurt
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
• Hungary
  • Pecs, Hungary, 7632
    • University of Pecs
  • Szombathely, Hungary, 9700
    • Markusovszky University Teaching Hospital
• Japan
  • Aichi, Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Chiba, Ichikawa, Japan, 272-8513
    • Tokyo Dental College Ichikawa General Hospital
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Gifu, Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hokkaido, Asahikawa, Japan, 078-8510
    • Asahikawa Medical University Hospital
  • Hokkaido, Obihiro, Japan, 080-0013
    • Takagi Dermatological Clinic
  • Kagawa, Takamatsu, Japan, 760-0017
    • Takamatsu Red Cross Hospital
  • Kanagawa, Sagamihara, Japan, 252-0392
    • Sagamihara National Hospital
  • Kumamoto, Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Nagano, Matsumoto, Japan, 390-8621
    • Shinshu University Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Okinawa, Nakagami-gun, Japan, 903-0215
    • University of the Ryukyus Hospital
  • Osaka, Osaka, Japan, 531-0071
    • Nakatsu Dermatology Clinic
  • Osaka, Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Osaka, Suita, Japan, 565-0871
    • Osaka University Hospital
  • Shiga, Otsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital
  • Tochigi, Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokyo, Itabashi-ku, Japan, 173-8606
    • Teikyo University Hospital
  • Tokyo, Itabashi-ku, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Wakayama, Wakayama, Japan, 641-8509
    • Wakayama Medical University Hospital
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
• Poland
  • Krakow, Poland, 31-559
    • Barbara Rewerska Diamond Clinic, Krakow
  • Lodz, Poland, 90-436
    • Dermoklinika medical center, Lodz
  • Lublin, Poland, 20-081
    • Independent Public Clin.Hosp.no1 Lublin
  • Olsztyn, Poland, 10-229
    • Municipal Hospital Complex in Olsztyn
  • Wroclaw, Poland, 51-318
    • Dermmedica Sp. z o.o., Wroclaw
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
  • Kazan, Russian Federation, 420111
    • LLC "Medical Center Azbuka Zdorovia"
  • Saint-Petersburg, Russian Federation, 194021
    • Dermatovenereological Dispensary #10, St. Petersburg
• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • The Psoriasis Treatment Center of Central New Jersey
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Research Institute
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Up to 260 weeks	Drug: Spesolimab; Spesolimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)	TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.	From first administration of study drug until last administration of study drug + 112 days, up to 869 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96	Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial * 100%.	Week 0 (baseline) and Week 48, Week 96
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96	Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.	Week 0 (baseline) and Week 48, Week 96
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96	Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation. The PPP PGA total score was derived as the mean of all individual components: 0 = If mean=0, for all three components: = If 0 < mean <1.5; = If 1.5 <= mean <2.5; = If 2.5 <= mean <3.5; = If mean >=3.5	Week 48 and Week 96

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 1368-0024; 2020-000189-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No