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Monoclonal Antibodies

GPP Patients for Pustular Psoriasis

Phase 4

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 1

Awards & highlights

Study Summary

This trial is for adults with a severe skin condition called generalized pustular psoriasis (GPP) who experience repeated flare-ups. The study aims to determine if a medication called spesolim

Who is the study for?

Adults with a serious skin condition called generalized pustular psoriasis (GPP) who frequently experience flares can join this study. They must have a history of GPP documented by specific criteria and be willing to use effective birth control if applicable. People under 18 or those not able to consent are excluded.Check my eligibility

What is being tested?

The trial is testing Spesolimab, given as an infusion into the vein at the start of a GPP flare, possibly followed by a second dose after one week. The study monitors how well Spesolimab treats these flares and checks for any health changes through regular skin exams and blood tests.See study design

What are the potential side effects?

While the exact side effects in this trial aren't listed, similar medications often cause reactions at the infusion site, infections due to immune system suppression, headaches, nausea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a mild or no pustulation from Generalized Pustular Psoriasis or I am currently experiencing a GPP flare.

Select...

I have a mild or no pustulation from Generalized Pustular Psoriasis or I am currently experiencing a GPP flare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1

Secondary outcome measures

Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635

Syncope

Colitis ulcerative

Nasopharyngitis

Anaemia

Rash

Infusion related reaction

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

300 mg Spesolimab (BI 655130) SD

1200 mg Spesolimab (BI 655130) q4w

450 mg Spesolimab (BI 655130) q4w

Trial Design

1Treatment groups

Experimental Treatment

Group I: GPP PatientsExperimental Treatment1 Intervention

Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spesolimab

2016

Completed Phase 3

~580

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,867 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this medical research study?

"Indeed, data from clinicaltrials.gov affirms that recruitment is ongoing for this trial. The study was first listed on October 11th, 2023 and last revised on February 5th, 2024. There is a requirement to enroll 40 patients spread across 36 different sites."

Answered by AI

What is the level of risk associated with GPP in patients?

"The safety of GPP Patients is rated 3 by our team at Power, given that this trial falls under Phase 4, signifying an approved therapy."

Answered by AI

Are multiple medical facilities in the United States involved in conducting this research?

"The recruitment for this research includes 36 available slots at esteemed institutions like Klinikum der Universität München AÖR in Munich, Hospital Sultanah Aminah in Johor Bahru, and Fondazione Policlinico Universitario Agostino Gemelli in Rome. Additionally, there are 33 more locations worldwide participating in patient enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013969.

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