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A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
NCT04399837 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04399837 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Michigan, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04399837?
The interventions under investigation include: Placebo (DRUG), Spesolimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04399837?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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