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

Stopped early · Phase 2

Conditions studied: Palmoplantar Pustulosis

In brief

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.

Key facts

Study ID: NCT04493424
Run by: Boehringer Ingelheim
People needed: 108
Starts: 2020-09-04
Expected to finish: 2023-05-15
Last updated by the study team: 2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Further exclusion criteria apply

Where it is running

University of Missouri Health System — Columbia, Missouri, United States
The Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Menter Dermatology Research Institute — Dallas, Texas, United States
University of Utah Health — Murray, Utah, United States
Paratus Clinical Research Woden — Phillip, Australian Capital Territory, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Skin Health Institute Inc — Carlton, Victoria, Australia
Royal Melbourne Hospital — Parkville, Victoria, Australia
Brussels - UNIV Saint-Luc — Brussels, Belgium
UZ Leuven — Leuven, Belgium
Dr. Irina Turchin PC Inc. — Fredericton, New Brunswick, Canada
SimcoDerm Medical and Surgical Dermatology Centre — Barrie, Ontario, Canada
The Guenther Dermatology Research Centre — London, Ontario, Canada
Innovaderm Research Inc. — Montreal, Quebec, Canada
CCBR Czech a.s. — Pardubice, Czechia
Univ. Hospital Kralovske Vinohrady — Prague, Czechia
Sanatorium Prof. Arenebergera — Prague, Czechia
HOP l'Archet — Nice, France
HOP Saint-Louis — Paris, France
HOP Larrey — Toulouse, France
Charité - Universitätsmedizin Berlin — Berlin, Germany
Universitätsklinikum Erlangen — Erlangen, Germany
Universitätsklinikum Frankfurt — Frankfurt am Main, Germany
Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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