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

2019-07-16 10:38:50 | BioPortfolio


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.

Study Design


Palmoplantar Pustulosis (PPP)


BI 655130, Placebo


Not yet recruiting


Boehringer Ingelheim

Results (where available)

View Results


Published on BioPortfolio: 2019-07-16T10:38:50-0400

Clinical Trials [27 Associated Clinical Trials listed on BioPortfolio]

Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.

A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of ANB019 in subjects with Palmoplantar Pustulosis (PPP)

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis

Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recom...

PubMed Articles [818 Associated PubMed Articles listed on BioPortfolio]

Molecular detection of fungal and bacterial DNA from pustules in patients with palmoplantar pustulosis: special focus on Malassezia species.

Palmoplantar pustulosis (PPP) is a distinct, chronic skin disorder characterized by intraepidermal pustules on the palms and soles. It is hypothesized that microorganisms on the skin might induce the ...

Interleukin-17 receptor A blockade with brodalumab in palmoplantar pustular psoriasis: Report on four cases.

Palmoplantar pustular psoriasis, also termed palmoplantar pustulosis (PPP), is a rare disease affecting the palmoplantar regions characterized by sterile, yellow to brown pustules mostly on erythemato...

Dental metal allergy is not the main cause of palmoplantar Pustulosis.

Metal allergy as a possible cause of Palmoplantar pustulosis (PPP) is a controversial issue, and in particular there is insufficient evidence that removal of dental metal leads to resolution of PPP....

Pompholyx vesicles contain small clusters of cells with high levels of hyaluronate resembling the pustulovesicles of palmoplantar pustulosis.

It is well-known that palmoplantar pustulosis (PPP) vesicles originate from eccrine sweat in the acrosyringium, and subsequently change into pustulovesicles and pustules . The histopathology of the pu...

Secukinumab for moderate to severe palmoplantar pustular psoriasis: Results of the 2PRECISE study.

Palmoplantar pustular psoriasis (PPP) is a debilitating disease of the palms and/or soles that is resistant to treatment. Secukinumab, an anti-IL-17A monoclonal antibody, is highly efficacious in the ...

Medical and Biotech [MESH] Definitions

A rare, benign rheumatologic disorder or syndrome characterized by hyperostosis and soft tissue ossification between the clavicles and the anterior part of the upper ribs. It is often associated with the dermatologic disorder palmoplantar pustulosis, particularly in Japan. Careful diagnosis is required to distinguish it from psoriatic arthritis, OSTEITIS DEFORMANS, and other diseases. Spondylitis of pustulosis palmaris et plantaris is one of the possible causes; also, evidence suggests one origin may be bone infection. Bone imaging is especially useful for diagnosis. It was originally described by Sonozaki in 1974.

An autosomal dominant disorder characterized by a widely distributed, well-demarcated hyperkeratosis of the palms and soles. There is more than one genotypically distinct form, each of which is clinically similar but histologically distinguishable. Diffuse palmoplantar keratoderma is distinct from palmoplantar keratoderma (KERATODERMA, PALMOPLANTAR), as the former exhibits autosomal dominant inheritance and hyperhidrosis is frequently present.

Syndrome consisting of synovitis, acne, palmoplantar pustulosis, hyperostosis, and osteitis (SAPHO). The most common site of the disease is the upper anterior chest wall, characterized by predominantly osteosclerotic lesions, hyperostosis, and arthritis of the adjacent joints. The association of sterile inflammatory bone lesions and neutrophilic skin eruptions is indicative of this syndrome.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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