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

Phase 2 Completed 152 enrolled Boehringer Ingelheim

RandomizedParallel-groupQuadruple-blindTreatment

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 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.

Timeline

Start: 2019-07-31
Primary completion: 2020-08-06
Completion: 2021-07-28

Outcome

Missed primary endpoint

paper The primary endpoint was not met; mean differences for spesolimab versus placebo ranged from - 14.6% (95% confidence interval [CI]: - 31.5%, 2.2%) to - 5.3% PMID 37731086 ↗

paper none reached significance. PMID 37731086 ↗

Publications

Burden AD, Bissonnette R, Navarini AA, Murakami M, Morita A, Haeufel T, Ye B, Baehner F, Terui T. Spesolimab Efficacy and Safety in Patients with Moderate-to-Severe Palmoplantar Pustulosis: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Phase IIb, Dose-Finding Study. Dermatol Ther (Heidelb). 2023 Oct;13(10):2279-2297. doi: 10.1007/s13555-023-01002-1. Epub 2023 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Spesolimab	Monoclonal antibody	300 mg	Subcutaneous
Subject	Spesolimab	Monoclonal antibody	600 mg	Subcutaneous