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

NCT04493424 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00242020-000189-41
• Study Type: interventional
• Target: 108
• Locations: 14 countries
• Sites: 66

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.

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96

  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

  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

  Week 48 and Week 96

Study Arms (1)

Treatment group

EXPERIMENTAL

Up to 260 weeks

Drug: Spesolimab

Interventions

Spesolimab DRUG

Spesolimab

Treatment group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (66)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, 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

Paratus Clinical Research Woden

Phillip, Australian Capital Territory, 2606, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, 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

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

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

CCBR Czech a.s.

Pardubice, 530 02, Czechia

Location

Univ. Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Sanatorium Prof. Arenebergera

Prague, 11000, Czechia

Location

HOP l'Archet

Nice, 06200, 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

University of Pecs

Pécs, 7632, Hungary

Location

Markusovszky University Teaching Hospital

Szombathely, 9700, Hungary

Location

Fujita Health University Hospital

Aichi, Toyoake, 470-1192, Japan

Location

Tokyo Dental College Ichikawa General Hospital

Chiba, Ichikawa, 272-8513, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, 078-8510, Japan

Location

Takagi Dermatological Clinic

Hokkaido, Obihiro, 080-0013, 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

Nakatsu Dermatology Clinic

Osaka, Osaka, 531-0071, Japan

Location

Osaka Metropolitan 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

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8509, Japan

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 Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The trial was prematurely discontinued due to the sponsor's (Boehringer Ingelheim) decision to terminate the clinical program studying spesolimab in patients with PPP. This decision was not based on any safety finding in the clinical trials.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: September 4, 2020
• Primary Completion: January 16, 2023
• Study Completion: May 15, 2023
• Last Updated: October 20, 2025
• Results First Posted: March 20, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3); TW (1); GB (2); JP (23); US (6); PL (5); AU (4); CA (4); CZ (3); DE (5); HU (2); BE (2); FR (3); KR (3)