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
Condition: Palmoplantar Pustulosis (PPP)
MeSH terms: Psoriasis
Intervention: Spesolimab; Placebo; Spesolimab; Spesolimab; Spesolimab; Spesolimab
Intervention description: Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.