Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Palmoplantar Pustulosis (PPP)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2021
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04015518
Start Date
July 31 2019
End Date
July 28 2021
Last Update
October 16 2025
Active Locations (88)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Wallace Medical Group
Beverly Hills, California, United States, 90211
3
Therapeutics Clinical Research
San Diego, California, United States, 92123
4
Advanced Medical Research PC
Sandy Springs, Georgia, United States, 30328