A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Palmoplantar Pustulosis (PPP)

In brief

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

Key facts

Study ID: NCT04015518
Run by: Boehringer Ingelheim
People needed: 152
Starts: 2019-07-31
Expected to finish: 2021-07-28
Last updated by the study team: 2025-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Wallace Medical Group — Beverly Hills, California, United States
Therapeutics Clinical Research — San Diego, California, United States
Advanced Medical Research PC — Sandy Springs, Georgia, United States
Epiphany Dermatology of Kansas, LLC — Overland Park, Kansas, United States
University of Missouri Health System — Columbia, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Skin Specialists, P.C. — Omaha, Nebraska, United States
The Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
Paddington Testing Co., Inc. — Philadelphia, Pennsylvania, 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
Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
Paratus Clinical Research Woden — Phillip, Australian Capital Territory, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Veracity Clinical Research — Wooloongabba, Queensland, Australia
Skin Health Institute Inc — Carlton, Victoria, Australia
Royal Melbourne Hospital — Parkville, Victoria, Australia
Brussels - UNIV Saint-Luc — Brussels, Belgium
UZ Leuven — Leuven, Belgium
CARe Clinic — Red Deer, Alberta, Canada
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
Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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