A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Launched by BOEHRINGER INGELHEIM · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called spesolimab can help adults with a serious skin condition known as generalized pustular psoriasis (GPP), especially those who experience frequent outbreaks. Participants in the study will receive an infusion of spesolimab into a vein when they have a flare-up of GPP, and they may receive a second dose a week later if their doctor believes it would be beneficial. Throughout the trial, doctors will monitor the participants' skin to see how well the treatment is working and will also check for any side effects.

To be eligible for this trial, participants must be at least 18 years old and have a history of GPP with frequent flare-ups. They need to provide consent to join the study and meet certain health criteria. It’s important to note that this trial is currently active but not recruiting new participants at this time. If you or someone you know has GPP and is interested in research on new treatments, it's a good idea to discuss options with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.
• • Patients must have a history of frequent GPP flares in the past
• • Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
• • Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures
• • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
• Exclusion Criteria:
• • Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
• • Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques
• • Patients with primary erythrodermic psoriasis vulgaris
• • Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
• • Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure
• • Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin
• • Presence of acute demyelinating neuropathy
• • Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator
• • Further exclusion criteria apply.