Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Spesolimab (high dose); Drug: Spesolimab (low dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03135548

1368-0015

2016-004573-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients, 18 to 65 years of age at screening.
• Palmoplantar Pustulosis
• Further inclusion criteria apply

Exclusion criteria

• Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar Pustulosis (PPP)-like disease.
• Active or latent tuberculosis
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

Spesolimab (low dose)

Experimental group

Treatment:

Drug: Spesolimab (low dose)

Spesolimab (high dose)

Experimental group

Treatment:

Drug: Spesolimab (high dose)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo