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Palmoplantar PustulosisPhase 2NCT04493424

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

A Phase 2 study testing Spesolimab in people with Palmoplantar Pustulosis, run by Boehringer Ingelheim at 66 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Pustulosis
What is being tested?
Spesolimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
66 sitesin 14 countries
Study dates
4 Sep 2020to 15 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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 locations and contacts

66 sites in 14 countries.

66 sites in 14 countries

Japan23 sites

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • Tokyo Dental College Ichikawa General Hospital

    Chiba, Ichikawa, 272-8513

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Asahikawa Medical University Hospital

    Hokkaido, Asahikawa, 078-8510

  • Takagi Dermatological Clinic

    Hokkaido, Obihiro, 080-0013

  • Takamatsu Red Cross Hospital

    Kagawa, Takamatsu, 760-0017

  • Sagamihara National Hospital

    Kanagawa, Sagamihara, 252-0392

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Shinshu University Hospital

    Nagano, Matsumoto, 390-8621

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • University of the Ryukyus Hospital

    Okinawa, Nakagami-gun, 903-0215

  • Nakatsu Dermatology Clinic

    Osaka, Osaka, 531-0071

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Osaka University Hospital

    Osaka, Suita, 565-0871

  • Shiga University of Medical Science Hospital

    Shiga, Otsu, 520-2192

  • Jichi Medical University Hospital

    Tochigi, Shimotsuke, 329-0498

  • Teikyo University Hospital

    Tokyo, Itabashi-ku, 173-8606

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8509

Other trials in Japan

United States6 sites

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama, 35205

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246

  • The Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • University of Utah Health

    Murray, Utah, 84107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

Germany5 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

Other trials in Germany

Poland5 sites

  • Barbara Rewerska Diamond Clinic, Krakow

    Krakow, 31-559

  • Dermoklinika medical center, Lodz

    Lodz, 90-436

  • Independent Public Clin.Hosp.no1 Lublin

    Lublin, 20-081

  • Municipal Hospital Complex in Olsztyn

    Olsztyn, 10-229

  • Dermmedica Sp. z o.o., Wroclaw

    Wroclaw, 51-318

Other trials in Poland

Australia4 sites

  • Skin Health Institute Inc

    Carlton, Victoria, 3053

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Paratus Clinical Research Woden

    Phillip, Australian Capital Territory, 2606

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada4 sites

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Dr. Irina Turchin PC Inc.

    Fredericton, New Brunswick, E3B 1G9

  • The Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

Other trials in Canada

Czechia3 sites

  • CCBR Czech a.s.

    Pardubice, 530 02

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34

  • Sanatorium Prof. Arenebergera

    Prague, 11000

Other trials in Czechia

France3 sites

  • HOP l'Archet

    Nice, 06200

  • HOP Saint-Louis

    Paris, 75010

  • HOP Larrey

    Toulouse, 31059

Other trials in France

Russia3 sites

  • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

    Chelyabinsk, 454048

  • LLC "Medical Center Azbuka Zdorovia"

    Kazan', 420111

  • Dermatovenereological Dispensary #10, St. Petersburg

    Saint Petersburg, 194021

Other trials in Russia

South Korea3 sites

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

Belgium2 sites

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Hungary2 sites

  • University of Pecs

    Pécs, 7632

  • Markusovszky University Teaching Hospital

    Szombathely, 9700

Other trials in Hungary

United Kingdom2 sites

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Guy's Hospital

    London, SE1 9RT

Other trials in United Kingdom

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials

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.

Being tested
Spesolimab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpesolimabDrug

    Spesolimab

Study groups in NCT04493424
Study groupRoleWhat they receive
Treatment groupExperimentalUp to 260 weeks
Receives: Drug: Spesolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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'.

    Measured: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.

Secondary outcomes (3)

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

    Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial * 100%.

    Measured: Week 0 (baseline) and Week 48, Week 96

  2. Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96

    Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.

    Measured: Week 0 (baseline) and Week 48, Week 96

  3. Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96

    Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation.

    The PPP PGA total score was derived as the mean of all individual components:

    0 = If mean=0, for all three components:

    1. = If 0 < mean <1.5
    2. = If 1.5 <= mean <2.5
    3. = If 2.5 <= mean <3.5
    4. = If mean >=3.5

    Measured: Week 48 and Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start4 Sep 2020
  3. Primary completion16 Jan 2023
  4. Study completion15 May 2023

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493424
Sponsor's protocol ID
1368-0024
Other IDs
2020-000189-41
Status last verified
Oct 2025
First submitted
28 Jul 2020
Last updated
20 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spesolimab in people with Palmoplantar Pustulosis, run by Boehringer Ingelheim at 66 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Japan, United States, Germany, Poland, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) (time frame: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04493424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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