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Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
NCT03886246 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up. Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.
Conditions Studied
Interventions
- DRUG Spesolimab
Study Locations (20)
Other
- Hospital Italiano de Buenos Aires — CABA
- Cliniques Universitaires 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
- Second Affiliated Hospital of Xi'an JiaoTong University — Xi'an
- HOP Saint-André — Bordeaux
- HOP l'Archet — Nice
- HOP Saint-Louis — Paris
- HOP Robert Debré — Reims
- Fachklinik Bad Bentheim — Bad Bentheim
- Charite Universitätsmedizin Berlin KöR — Berlin
- Universitätsklinikum Bonn AöR — Bonn
- Universitätsklinikum Frankfurt — Frankfurt am Main
- Klinikum der Universität München - Campus Innenstadt — München
- Westfälische Wilhelms-Universität Münster — Münster
Michigan
- Oakland Hills Dermatology — Auburn Hills
New York
- Icahn School of Medicine at Mount Sinai — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2028-04-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03886246
The ClinicalTrials.gov registry entry for NCT03886246 describes a study currently listed as active not recruiting. 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 131 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 1 intervention — of which Spesolimab 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: NCT03886246 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Michigan, New York. 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 NCT03886246 about?
NCT03886246 is a clinical study titled "Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study". This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolima...
What is the current status of trial NCT03886246?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2019-05-29. Estimated completion is 2028-04-27.
What conditions does trial NCT03886246 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 NCT03886246?
The interventions under investigation include: Spesolimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03886246?
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 NCT03886246 being conducted?
This trial has 20 study locations across Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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