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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Palmoplantar Pustulosis (PPP)

Treatments: Drug: Spesolimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04015518

1368-0016

2018-003078-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 5 patient groups

Placebo & Spesolimab

Other group

Description:

Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.

Treatment:

Drug: Spesolimab

Drug: Placebo

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Spesolimab 'Speso Low'

Experimental group

Description:

Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.

Treatment:

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Spesolimab 'Speso Medium-low'

Experimental group

Description:

Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.

Treatment:

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Spesolimab 'Speso Medium-high'

Experimental group

Description:

Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.

Treatment:

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Spesolimab 'Speso High'

Experimental group

Description:

Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.

Treatment:

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab

Drug: Spesolimab