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

NCT04015518 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00162018-003078-28
• Study Type: interventional
• Target: 152
• Locations: 15 countries
• Sites: 88

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  week 0 (baseline) and week 16

Secondary Outcomes (8)

• Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4

  week 0 (baseline) and week 4.

• Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16

  week 0 (baseline) and week 16.

• Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16

  week 0 (baseline) and week 16.

• Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)

  week 0 (baseline) and week 16

• Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)

  week 0 (baseline) and week 16

Study Arms (5)

Placebo & Spesolimab

OTHER

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

Drug: Spesolimab; Drug: Placebo

Spesolimab 'Speso Low'

EXPERIMENTAL

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

Drug: Spesolimab

Spesolimab 'Speso Medium-low'

EXPERIMENTAL

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

Drug: Spesolimab

Spesolimab 'Speso Medium-high'

EXPERIMENTAL

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

Drug: Spesolimab

Spesolimab 'Speso High'

EXPERIMENTAL

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

Drug: Spesolimab

Interventions

Spesolimab DRUG

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

Placebo & Spesolimab

Placebo DRUG

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

Placebo & Spesolimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (88)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Wallace Medical Group

Beverly Hills, California, 90211, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66215, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Skin Specialists, P.C.

Omaha, Nebraska, 68144, United States

Location

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

University of Utah Health

Murray, Utah, 84107, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Paratus Clinical Research Woden

Phillip, Australian Capital Territory, 2606, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Veracity Clinical Research

Wooloongabba, Queensland, 4102, Australia

Location

Skin Health Institute Inc

Carlton, Victoria, 3053, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Brussels - UNIV Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CARe Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

CCBR Czech a.s.

Pardubice, 530 02, Czechia

Location

Sanatorium Prof. Arenebergera

Prague, 11000, Czechia

Location

CCBR Czech Prague s.r.o.

Prague, 130 00, Czechia

Location

HOP l'Archet

Nice, 06202, France

Location

HOP Saint-Louis

Paris, 75010, France

Location

HOP Larrey

Toulouse, 31059, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

CRU Hungary Ltd, Private Practice, Miskolc

Miskolc, 3529, Hungary

Location

University of Pecs

Pécs, 7632, Hungary

Location

Markusovszky University Teaching Hospital

Szombathely, 9700, Hungary

Location

Veszprem County Csolnoky Ferenc Hospital

Veszprém, 8200, Hungary

Location

Nagoya City University Hospital

Aichi, Nagoya, 467-8602, Japan

Location

Fujita Health University Hospital

Aichi, Toyoake, 470-1192, Japan

Location

Tokyo Dental College Ichikawa General Hospital

Chiba, Ichikawa, 272-8513, Japan

Location

Ehime University Hospital

Ehime, Toon, 791-0295, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Asahikawa Kosei General Hospital

Hokkaido, Asahikawa, 078-8211, Japan

Location

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, 078-8510, Japan

Location

Takagi Dermatological Clinic

Hokkaido, Obihiro, 080-0013, Japan

Location

Hosui General Medical Clinic

Hokkaido, Sapporo, 064-0807, Japan

Location

Takamatsu Red Cross Hospital

Kagawa, Takamatsu, 760-0017, Japan

Location

Sagamihara National Hospital

Kanagawa, Sagamihara, 252-0392, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Shinshu University Hospital

Nagano, Matsumoto, 390-8621, Japan

Location

Okayama University Hospital

Okayama, Okayama, 700-8558, Japan

Location

University of the Ryukyus Hospital

Okinawa, Nakagami-gun, 903-0215, Japan

Location

Kindai University Hospital

Osaka, Osaka-sayama, 589-8511, Japan

Location

Nakatsu Dermatology Clinic

Osaka, Osaka, 531-0072, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan

Location

Osaka University Hospital

Osaka, Suita, 565-0871, Japan

Location

Shiga University of Medical Science Hospital

Shiga, Otsu, 520-2192, Japan

Location

Jichi Medical University Hospital

Tochigi, Shimotsuke, 329-0498, Japan

Location

Teikyo University Hospital

Tokyo, Itabashi-ku, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, 173-8610, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, 160-0023, Japan

Location

Seibo Hospital

Tokyo, Shinjuku, 161-8521, Japan

Location

Shirasaki Dermatology and Neurology Clinic

Toyama, Takaoka, 933-0871, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8509, Japan

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Barbara Rewerska Diamond Clinic, Krakow

Krakow, 31-559, Poland

Location

Dermoklinika medical center, Lodz

Lodz, 90-436, Poland

Location

Independent Public Clin.Hosp.no1 Lublin

Lublin, 20-081, Poland

Location

Municipal Hospital Complex in Olsztyn

Olsztyn, 10-229, Poland

Location

Dermmedica Sp. z o.o., Wroclaw

Wroclaw, 51-318, Poland

Location

SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

Chelyabinsk, 454048, Russia

Location

LLC "Medical Center Azbuka Zdorovia"

Kazan', 420111, Russia

Location

Dermatovenereological Dispensary #10, St. Petersburg

Saint Petersburg, 194021, Russia

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39216969 DERIVED

• 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.

  PMID: 37731086 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: July 31, 2019
• Primary Completion: August 6, 2020
• Study Completion: July 28, 2021
• Last Updated: October 16, 2025
• Results First Posted: July 28, 2022

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); RU (3); CZ (3); FR (3); BE (2); HU (4); PL (5); AU (5); US (14); CA (7); NL (1); DE (5); KR (3); GB (2); JP (30)