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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04493424
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Palmoplantar Pustulosis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Treatment group

Up to 260 weeks

Interventions

Drug: - Spesolimab

Spesolimab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Active, not recruiting

Address

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205

University of Missouri Health System, Columbia, Missouri

Status

Active, not recruiting

Address

University of Missouri Health System

Columbia, Missouri, 65212

East Windsor, New Jersey

Status

Active, not recruiting

Address

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Active, not recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Menter Dermatology Research Institute, Dallas, Texas

Status

Active, not recruiting

Address

Menter Dermatology Research Institute

Dallas, Texas, 75246

University of Utah Health, Murray, Utah

Status

Active, not recruiting

Address

University of Utah Health

Murray, Utah, 84107

International Sites

Woden Dermatology, Phillip, Australian Capital Territory, Australia

Status

Recruiting

Address

Woden Dermatology

Phillip, Australian Capital Territory, 2606

Site Contact

Diana Rubel

[email protected]

+612 6282 8410

Westmead Hospital, Westmead, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Site Contact

Pablo Fernandez-Penas

[email protected]

61 2 8890 9767

Skin Health Institute Inc, Carlton, Victoria, Australia

Status

Recruiting

Address

Skin Health Institute Inc

Carlton, Victoria, 3053

Site Contact

Peter Foley

[email protected]

+61 3 9623 9400

Royal Melbourne Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

Royal Melbourne Hospital

Parkville, Victoria, 3050

Site Contact

Johannes Kern

[email protected]

61 3 9342 4531

Brussels - UNIV Saint-Luc, Bruxelles, Belgium

Status

Recruiting

Address

Brussels - UNIV Saint-Luc

Bruxelles, , 1200

Site Contact

Pierre-Dominique Ghislain

[email protected]

+32 (0)2 764 14 72

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Site Contact

Tom Hillary

[email protected]

+32 16 33 79 50

Dr. Irina Turchin PC Inc., Fredericton, New Brunswick, Canada

Status

Active, not recruiting

Address

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9

Barrie, Ontario, Canada

Status

Completed

Address

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1

The Guenther Dermatology Research Centre, London, Ontario, Canada

Status

Active, not recruiting

Address

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7

Innovaderm Research Inc., Montreal, Quebec, Canada

Status

Active, not recruiting

Address

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1

CCBR Czech a.s., Pardubice, Czechia

Status

Recruiting

Address

CCBR Czech a.s.

Pardubice, , 530 02

Site Contact

Jaroslava Vaneckova

[email protected]

+420 774 477 460

Sanatorium Prof. Arenebergera, Prague, Czechia

Status

Recruiting

Address

Sanatorium Prof. Arenebergera

Prague, , 11000

Site Contact

Petr Arenberger

[email protected]

+420602214443

HOP l'Archet, Nice, France

Status

Active, not recruiting

Address

HOP l'Archet

Nice, , 06200

HOP Saint-Louis, Paris, France

Status

Active, not recruiting

Address

HOP Saint-Louis

Paris, , 75010

HOP Larrey, Toulouse, France

Status

Active, not recruiting

Address

HOP Larrey

Toulouse, , 31059

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Active, not recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Frankfurt

Frankfurt am Main, , 60596

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Completed

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

Kiel, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , 24105

University of Pecs, Pecs, Hungary

Status

Recruiting

Address

University of Pecs

Pecs, , 7632

Site Contact

Rolland Gyulai

[email protected]

+3672536882

Szombathely, Hungary

Status

Recruiting

Address

Markusovszky University Teaching Hospital

Szombathely, , 9700

Site Contact

Eniko Telegdy

[email protected]

+36943115425671

Fujita Health University Hospital, Aichi, Toyoake, Japan

Status

Active, not recruiting

Address

Fujita Health University Hospital

Aichi, Toyoake, , 470-1192

Chiba, Ichikawa, Japan

Status

Completed

Address

Tokyo Dental College Ichikawa General Hospital

Chiba, Ichikawa, , 272-8513

Fukuoka University Hospital, Fukuoka, Fukuoka, Japan

Status

Active, not recruiting

Address

Fukuoka University Hospital

Fukuoka, Fukuoka, , 814-0180

Gifu University Hospital, Gifu, Gifu, Japan

Status

Active, not recruiting

Address

Gifu University Hospital

Gifu, Gifu, , 501-1194

Asahikawa Medical University Hospital, Hokkaido, Asahikawa, Japan

Status

Active, not recruiting

Address

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, , 078-8510

Takagi Dermatological Clinic, Hokkaido, Obihiro, Japan

Status

Active, not recruiting

Address

Takagi Dermatological Clinic

Hokkaido, Obihiro, , 080-0013

Takamatsu Red Cross Hospital, Kagawa, Takamatsu, Japan

Status

Active, not recruiting

Address

Takamatsu Red Cross Hospital

Kagawa, Takamatsu, , 760-0017

Sagamihara National Hospital, Kanagawa, Sagamihara, Japan

Status

Active, not recruiting

Address

Sagamihara National Hospital

Kanagawa, Sagamihara, , 252-0392

Kumamoto University Hospital, Kumamoto, Kumamoto, Japan

Status

Active, not recruiting

Address

Kumamoto University Hospital

Kumamoto, Kumamoto, , 860-8556

Kyoto, Kyoto, Japan

Status

Active, not recruiting

Address

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, , 602-8566

Tohoku University Hospital, Miyagi, Sendai, Japan

Status

Active, not recruiting

Address

Tohoku University Hospital

Miyagi, Sendai, , 980-8574

Shinshu University Hospital, Nagano, Matsumoto, Japan

Status

Active, not recruiting

Address

Shinshu University Hospital

Nagano, Matsumoto, , 390-8621

Okayama University Hospital, Okayama, Okayama, Japan

Status

Active, not recruiting

Address

Okayama University Hospital

Okayama, Okayama, , 700-8558

University of the Ryukyus Hospital, Okinawa, Nakagami-gun, Japan

Status

Active, not recruiting

Address

University of the Ryukyus Hospital

Okinawa, Nakagami-gun, , 903-0215

Nakatsu Dermatology Clinic, Osaka, Osaka, Japan

Status

Active, not recruiting

Address

Nakatsu Dermatology Clinic

Osaka, Osaka, , 531-0072

Osaka City University Hospital, Osaka, Osaka, Japan

Status

Active, not recruiting

Address

Osaka City University Hospital

Osaka, Osaka, , 545-8586

Osaka University Hospital, Osaka, Suita, Japan

Status

Active, not recruiting

Address

Osaka University Hospital

Osaka, Suita, , 565-0871

Shiga, Otsu, Japan

Status

Active, not recruiting

Address

Shiga University of Medical Science Hospital

Shiga, Otsu, , 520-2192

Jichi Medical University Hospital, Tochigi, Shimotsuke, Japan

Status

Active, not recruiting

Address

Jichi Medical University Hospital

Tochigi, Shimotsuke, , 329-0498

Teikyo University Hospital, Tokyo, Itabashi-ku, Japan

Status

Active, not recruiting

Address

Teikyo University Hospital

Tokyo, Itabashi-ku, , 173-8606

Nihon University Itabashi Hospital, Tokyo, Itabashi-ku, Japan

Status

Active, not recruiting

Address

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, , 173-8610

Tokyo Medical University Hospital, Tokyo, Shinjuku-ku, Japan

Status

Active, not recruiting

Address

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, , 160-0023

Wakayama Medical University Hospital, Wakayama, Wakayama, Japan

Status

Active, not recruiting

Address

Wakayama Medical University Hospital

Wakayama, Wakayama, , 641-8510

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Active, not recruiting

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seongnam, Korea, Republic of

Status

Active, not recruiting

Address

Seoul National University Bundang Hospital

Seongnam, , 13620

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Barbara Rewerska Diamond Clinic, Krakow, Krakow, Poland

Status

Recruiting

Address

Barbara Rewerska Diamond Clinic, Krakow

Krakow, , 31-559

Site Contact

Barbara Rewerska

[email protected]

+48 696049029

Dermoklinika medical center, Lodz, Lodz, Poland

Status

Recruiting

Address

Dermoklinika medical center, Lodz

Lodz, , 90-436

Site Contact

Aleksandra Lesiak

[email protected]

+48 42 230 96 57, +48609279389

Independent Public Clin.Hosp.no1 Lublin, Lublin, Poland

Status

Recruiting

Address

Independent Public Clin.Hosp.no1 Lublin

Lublin, , 20-081

Site Contact

Dorota Krasowska

[email protected]

+48815349677, +48608098578

Municipal Hospital Complex in Olsztyn, Olsztyn, Poland

Status

Recruiting

Address

Municipal Hospital Complex in Olsztyn

Olsztyn, , 10-229

Site Contact

Waldemar Placek

[email protected]

+48896786654

Dermmedica Sp. z o.o., Wroclaw, Wroclaw, Poland

Status

Recruiting

Address

Dermmedica Sp. z o.o., Wroclaw

Wroclaw, , 51-318

Site Contact

Jolanta Weglowska

[email protected]

+48713253446, +48 501425260

SBHI Chelyabinsk Reg.Clin.Derma.Dispen., Chelyabinsk, Russian Federation

Status

Recruiting

Address

SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

Chelyabinsk, , 454048

Site Contact

Oleg Ziganshin

[email protected]

+73512320093

LLC "Medical Center Azbuka Zdorovia", Kazan, Russian Federation

Status

Recruiting

Address

LLC "Medical Center Azbuka Zdorovia"

Kazan, , 420111

Site Contact

Bulat Khalilov

[email protected]

+78435280206

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Dermatovenereological Dispensary #10, St. Petersburg

Saint-Petersburg, , 194021

Site Contact

Alexey Sukharev

[email protected]

+78123297168

National Taiwan University Hospital, Taipei, Taiwan

Status

Completed

Address

National Taiwan University Hospital

Taipei, , 10002

Royal Devon and Exeter Hospital, Exeter, United Kingdom

Status

Active, not recruiting

Address

Royal Devon and Exeter Hospital

Exeter, , EX2 5DW

Guy's Hospital, London, United Kingdom

Status

Active, not recruiting

Address

Guy's Hospital

London, , SE1 9RT

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