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

NCT ID: NCT04015518

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-07-28

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.

Conditions

Palmoplantar Pustulosis (PPP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo & Spesolimab

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

Group Type: OTHER

Spesolimab

Intervention Type: DRUG

Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.

Placebo

Intervention Type: DRUG

Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.

Spesolimab 'Speso Low'

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

Group Type: EXPERIMENTAL

Spesolimab

Intervention Type: DRUG

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

Spesolimab 'Speso Medium-low'

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

Group Type: EXPERIMENTAL

Spesolimab

Intervention Type: DRUG

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

Spesolimab 'Speso Medium-high'

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

Group Type: EXPERIMENTAL

Spesolimab

Intervention Type: DRUG

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

Spesolimab 'Speso High'

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

Group Type: EXPERIMENTAL

Spesolimab

Intervention Type: DRUG

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

Interventions

Spesolimab

Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.

Intervention Type: DRUG

Placebo

Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.

Intervention Type: DRUG

Spesolimab

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

Intervention Type: DRUG

Spesolimab

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

Intervention Type: DRUG

Spesolimab

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

Intervention Type: DRUG

Spesolimab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Wallace Medical Group

Beverly Hills, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Advanced Medical Research PC

Sandy Springs, Georgia, United States

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

University of Missouri Health System

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Skin Specialists, P.C.

Omaha, Nebraska, United States

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

University of Utah Health

Murray, Utah, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Paratus Clinical Research Woden

Phillip, Australian Capital Territory, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Veracity Clinical Research

Wooloongabba, Queensland, Australia

Skin Health Institute Inc

Carlton, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Brussels - UNIV Saint-Luc

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

CARe Clinic

Red Deer, Alberta, Canada

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, Canada

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

The Guenther Dermatology Research Centre

London, Ontario, Canada

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada

K. Papp Clinical Research Inc.

Waterloo, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

CCBR Czech a.s.

Pardubice, , Czechia

Sanatorium Prof. Arenebergera

Prague, , Czechia

CCBR Czech Prague s.r.o.

Prague, , Czechia

HOP l'Archet

Nice, , France

HOP Saint-Louis

Paris, , France

HOP Larrey

Toulouse, , France

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

CRU Hungary Ltd, Private Practice, Miskolc

Miskolc, , Hungary

University of Pecs

Pécs, , Hungary

Markusovszky University Teaching Hospital

Szombathely, , Hungary

Veszprem County Csolnoky Ferenc Hospital

Veszprém, , Hungary

Nagoya City University Hospital

Aichi, Nagoya, , Japan

Fujita Health University Hospital

Aichi, Toyoake, , Japan

Tokyo Dental College Ichikawa General Hospital

Chiba, Ichikawa, , Japan

Ehime University Hospital

Ehime, Toon, , Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, , Japan

Gifu University Hospital

Gifu, Gifu, , Japan

Asahikawa Kosei General Hospital

Hokkaido, Asahikawa, , Japan

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, , Japan

Takagi Dermatological Clinic

Hokkaido, Obihiro, , Japan

Hosui General Medical Clinic

Hokkaido, Sapporo, , Japan

Takamatsu Red Cross Hospital

Kagawa, Takamatsu, , Japan

Sagamihara National Hospital

Kanagawa, Sagamihara, , Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, , Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, , Japan

Tohoku University Hospital

Miyagi, Sendai, , Japan

Shinshu University Hospital

Nagano, Matsumoto, , Japan

Okayama University Hospital

Okayama, Okayama, , Japan

University of the Ryukyus Hospital

Okinawa, Nakagami-gun, , Japan

Kindai University Hospital

Osaka, Osaka-sayama, , Japan

Nakatsu Dermatology Clinic

Osaka, Osaka, , Japan

Osaka City University Hospital

Osaka, Osaka, , Japan

Osaka University Hospital

Osaka, Suita, , Japan

Shiga University of Medical Science Hospital

Shiga, Otsu, , Japan

Jichi Medical University Hospital

Tochigi, Shimotsuke, , Japan

Teikyo University Hospital

Tokyo, Itabashi-ku, , Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, , Japan

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, , Japan

Seibo Hospital

Tokyo, Shinjuku, , Japan

Shirasaki Dermatology and Neurology Clinic

Toyama, Takaoka, , Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, , Japan

Amphia Ziekenhuis

Breda, , Netherlands

Barbara Rewerska Diamond Clinic, Krakow

Krakow, , Poland

Dermoklinika medical center, Lodz

Lodz, , Poland

Independent Public Clin.Hosp.no1 Lublin

Lublin, , Poland

Municipal Hospital Complex in Olsztyn

Olsztyn, , Poland

Dermmedica Sp. z o.o., Wroclaw

Wroclaw, , Poland

SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

Chelyabinsk, , Russia

LLC "Medical Center Azbuka Zdorovia"

Kazan', , Russia

Dermatovenereological Dispensary #10, St. Petersburg

Saint Petersburg, , Russia

Gachon University Gil Medical Center

Incheon, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

National Taiwan University Hospital

Taipei, , Taiwan

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Guy's Hospital

London, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Czechia; France; Germany; Hungary; Japan; Netherlands; Poland; Russia; South Korea; Taiwan; United Kingdom

References

Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.

Reference Type: DERIVED

PMID: 39216969 (View on PubMed)

Burden AD, Bissonnette R, Navarini AA, Murakami M, Morita A, Haeufel T, Ye B, Baehner F, Terui T. Spesolimab Efficacy and Safety in Patients with Moderate-to-Severe Palmoplantar Pustulosis: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Phase IIb, Dose-Finding Study. Dermatol Ther (Heidelb). 2023 Oct;13(10):2279-2297. doi: 10.1007/s13555-023-01002-1. Epub 2023 Sep 20.

Reference Type: DERIVED

PMID: 37731086 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://mystudywindow.com

Related Info

Other Identifiers

2018-003078-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1368-0016

Identifier Type: -

Identifier Source: org_study_id