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Spesolimab shows promise for Long-Term control of painful hand and foot pustules

NCT ID NCT04493424

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looks at the long-term safety of spesolimab for people with palmoplantar pustulosis, a chronic skin condition causing painful pustules on hands and feet. Participants who benefited from spesolimab in earlier trials can continue treatment for up to 5 years, with monthly injections and regular check-ups. The goal is to see if the drug remains safe and helps control symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spesolimab
What this could lead to
If successful, this could show that spesolimab is safe and effective for long-term control of palmoplantar pustulosis, offering a treatment option for this chronic skin condition.
What could go wrong
This is a small, early-phase extension study that was terminated early, so results may be limited. Long-term safety and effectiveness are not yet proven, and side effects are possible.

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

108 people

The number who actually took part.

Started

Sep 2020

Finished

May 2023

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 years and older

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: * 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

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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

Contacts and locations

Locations

  • 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

  • CCBR Czech a.s.

    Pardubice, 530 02, Czechia

  • 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

  • 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, 06200, France

  • 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

  • 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

  • Nakatsu Dermatology Clinic

    Osaka, Osaka, 531-0071, 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 Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Osaka University Hospital

    Osaka, Suita, 565-0871, Japan

  • 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

  • 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

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Skin Health Institute Inc

    Carlton, Victoria, 3053, Australia

  • 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

  • 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

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34, Czechia

  • 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

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8509, Japan

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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