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NCT04399837 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
A Phase 2 study of Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT04399837 is a Phase 2 study of Generalized Pustular Psoriasis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 123 participants, roughly in line with the 124-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target. The trial reports 20 study locations across 3 states.
The verdict
NCT04399837, a Phase 2 study of Generalized Pustular Psoriasis, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups. Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine. Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants. If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Spesolimab
Study Locations (20)
Other
- Buenos Aires Skin S.A. - CABA
- Hospital Italiano de Buenos Aires - CABA
- Brussels - UNIV Saint-Luc - Brussels
- Clínica Dermacross S.A. - Vitacura
- Sun yet-sen Memorial Hospital, Sun yet-sen Univesity - Guangzhou
- The Second Affiliated Hospital Zhejiang University School of Medicine - Hangzhou
- Shanghai Skin Disease Hospital - Shanghai
- Huashan Hospital, Fudan University - Shanghai
- The First Hospital of China Medical University - Shenyang
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital - Tianjin
- Second Affiliated Hospital of Xi'an JiaoTong University - Xi'an
- HOP l'Archet - Nice
- HOP Saint-Louis - Paris
- Fachklinik Bad Bentheim - Bad Bentheim
- Universitätsklinikum Bonn AöR - Bonn
- Universitätsklinikum Frankfurt - Frankfurt am Main
- Klinikum der Universität München - Campus Innenstadt - München
- Universitätsklinikum Münster - Münster
Michigan
- Oakland Hills Dermatology - Auburn Hills
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2020-06-04 |
| Est. Completion | 2022-11-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04399837
The ClinicalTrials.gov registry entry for NCT04399837 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 124-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Generalized Pustular Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04399837 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT04399837 about?
NCT04399837 is a clinical study titled "A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis". This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study...
What is the current status of trial NCT04399837?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2020-06-04. Estimated completion is 2022-11-23.
What conditions does trial NCT04399837 study?
This clinical trial studies the following conditions: Generalized Pustular Psoriasis.
What interventions are being tested in trial NCT04399837?
The interventions under investigation include: Placebo (DRUG), Spesolimab (DRUG).
Who is sponsoring clinical trial NCT04399837?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04399837 being conducted?
This trial has 20 study locations across Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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