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New drug shows promise for painful hand and foot pustules

NCT ID NCT04015518

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested four different doses of an experimental drug (BI 655130) against a placebo in 152 adults with moderate to severe palmoplantar pustulosis (PPP), a skin condition causing painful pus-filled blisters on the palms and soles. The main goal was to see which dose best reduces skin redness, pustules, and scaling after 16 weeks. Researchers also measured pain relief and safety. The drug aims to control the disease, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

152 people

The number who actually took part.

Started

Jul 2019

Finished

Jul 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

palmoplantar pustulosis psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Palmoplantar pustulosis (PPP)

Contacts and locations

Locations

  • Advanced Medical Research PC

    Sandy Springs, Georgia, 30328, United States

  • Amphia Ziekenhuis

    Breda, 4818 CK, Netherlands

  • Asahikawa Kosei General Hospital

    Hokkaido, Asahikawa, 078-8211, Japan

  • Asahikawa Medical University Hospital

    Hokkaido, Asahikawa, 078-8510, Japan

  • Barbara Rewerska Diamond Clinic, Krakow

    Krakow, 31-559, Poland

  • Brussels - UNIV Saint-Luc

    Brussels, 1200, Belgium

  • CARe Clinic

    Red Deer, Alberta, T4P 1K4, Canada

  • CCBR Czech Prague s.r.o.

    Prague, 130 00, Czechia

  • CCBR Czech a.s.

    Pardubice, 530 02, Czechia

  • CRU Hungary Ltd, Private Practice, Miskolc

    Miskolc, 3529, Hungary

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Dermatovenereological Dispensary #10, St. Petersburg

    Saint Petersburg, 194021, Russia

  • Dermmedica Sp. z o.o., Wroclaw

    Wroclaw, 51-318, Poland

  • Dermoklinika medical center, Lodz

    Lodz, 90-436, Poland

  • Dr. Irina Turchin PC Inc.

    Fredericton, New Brunswick, E3B 1G9, Canada

  • Ehime University Hospital

    Ehime, Toon, 791-0295, Japan

  • Epiphany Dermatology of Kansas, LLC

    Overland Park, Kansas, 66215, United States

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192, Japan

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • HOP Larrey

    Toulouse, 31059, France

  • HOP Saint-Louis

    Paris, 75010, France

  • HOP l'Archet

    Nice, 06202, France

  • Hosui General Medical Clinic

    Hokkaido, Sapporo, 064-0807, Japan

  • Independent Public Clin.Hosp.no1 Lublin

    Lublin, 20-081, Poland

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1, Canada

  • Jichi Medical University Hospital

    Tochigi, Shimotsuke, 329-0498, Japan

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario, N2J 1C4, Canada

  • Kindai University Hospital

    Osaka, Osaka-sayama, 589-8511, Japan

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556, Japan

  • LLC "Medical Center Azbuka Zdorovia"

    Kazan', 420111, Russia

  • Markusovszky University Teaching Hospital

    Szombathely, 9700, Hungary

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246, United States

  • Municipal Hospital Complex in Olsztyn

    Olsztyn, 10-229, Poland

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602, Japan

  • Nakatsu Dermatology Clinic

    Osaka, Osaka, 531-0072, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610, Japan

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Osaka University Hospital

    Osaka, Suita, 565-0871, Japan

  • Paddington Testing Co., Inc.

    Philadelphia, Pennsylvania, 19103, United States

  • Paratus Clinical Research Woden

    Phillip, Australian Capital Territory, 2606, Australia

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW, United Kingdom

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

    Chelyabinsk, 454048, Russia

  • Sagamihara National Hospital

    Kanagawa, Sagamihara, 252-0392, Japan

  • Sanatorium Prof. Arenebergera

    Prague, 11000, Czechia

  • Seibo Hospital

    Tokyo, Shinjuku, 161-8521, Japan

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shiga University of Medical Science Hospital

    Shiga, Otsu, 520-2192, Japan

  • Shinshu University Hospital

    Nagano, Matsumoto, 390-8621, Japan

  • Shirasaki Dermatology and Neurology Clinic

    Toyama, Takaoka, 933-0871, Japan

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Skin Health Institute Inc

    Carlton, Victoria, 3053, Australia

  • Skin Specialists, P.C.

    Omaha, Nebraska, 68144, United States

  • Takagi Dermatological Clinic

    Hokkaido, Obihiro, 080-0013, Japan

  • Takamatsu Red Cross Hospital

    Kagawa, Takamatsu, 760-0017, Japan

  • Teikyo University Hospital

    Tokyo, Itabashi-ku, 173-8606, Japan

  • The Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7, Canada

  • The Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520, United States

  • Therapeutics Clinical Research

    San Diego, California, 92123, United States

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Tokyo Dental College Ichikawa General Hospital

    Chiba, Ichikawa, 272-8513, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama, 35205, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • University of Missouri Health System

    Columbia, Missouri, 65212, United States

  • University of Pecs

    Pécs, 7632, Hungary

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah Health

    Murray, Utah, 84107, United States

  • University of the Ryukyus Hospital

    Okinawa, Nakagami-gun, 903-0215, Japan

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Veracity Clinical Research

    Wooloongabba, Queensland, 4102, Australia

  • Veszprem County Csolnoky Ferenc Hospital

    Veszprém, 8200, Hungary

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502, United States

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8509, Japan

  • Wallace Medical Group

    Beverly Hills, California, 90211, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4C 9M7, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.