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NCT06013969 · ClinicalTrials.gov registry record · Phase 4
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
A Phase 4 study of Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT06013969: Active Phase 4 study of Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim.
NCT06013969 is a Phase 4 study of Generalized Pustular Psoriasis that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 42 participants, below the 151-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06013969, a Phase 4 study of Generalized Pustular Psoriasis, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Spesolimab
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- Hospital Universitario Evangelico Mackenzie - Curitiba
- Faculdade de Medicina do ABC - Santo André
- Southern Medical University Dermatology Hospital - Guangzhou
- Shanghai Skin Disease Hospital - Shanghai
- Shanghai Tenth People's Hospital - Shanghai
- HOP Trousseau - Chambray-lès-Tours
- HOP Saint-Louis - Paris
- Universitätsklinikum Frankfurt - Frankfurt am Main
- Klinikum der Universität München AÖR - München
- SP medical college and associated group of hospitals - Bikaner
- Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital - Nagpur
- ASST degli Spedali Civili di Brescia - Brescia
- Hospital Selayang - Batu Caves
- Hospital Pulau Pinang-Pulau Pinang-21953 - Georgetown Pulau Pinang
- Hospital Sultanah Aminah - Johor Bahru
New South Wales
- Liverpool Hospital - Liverpool
- Westmead Hospital - Westmead
California
- University of California Irvine - Irvine
North Dakota
- Red River Research Partners, LLC - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-10-22 |
| Est. Completion | 2026-08-14 |
| Phase | Phase 4 |
What the registry record for NCT06013969 still lists
NCT06013969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 151-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Generalized Pustular Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which Spesolimab is the first listed.
NCT06013969 names 20 study sites across 4 states, led by Other, New South Wales, California.
Frequently Asked Questions
What is clinical trial NCT06013969 about?
NCT06013969 is a clinical study titled "A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares". This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of speso...
What is the current status of trial NCT06013969?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2023-10-22. Estimated completion is 2026-08-14.
What conditions does trial NCT06013969 study?
This clinical trial studies the following conditions: Generalized Pustular Psoriasis.
What interventions are being tested in trial NCT06013969?
The interventions under investigation include: Spesolimab (DRUG).
Who is sponsoring clinical trial NCT06013969?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06013969 being conducted?
This trial has 20 study locations across California, North Dakota, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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