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NCT03886246 · ClinicalTrials.gov registry record · Phase 2
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
A Phase 2 study of Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT03886246: Active Phase 2 study of Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim.
NCT03886246 is a Phase 2 study of Generalized Pustular Psoriasis that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 131 participants, roughly in line with the 122-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03886246, a Phase 2 study of Generalized Pustular Psoriasis, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT03886246 still lists
NCT03886246 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 122-participant average among 3 other Generalized Pustular Psoriasis trials with a reported enrollment target.
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.
NCT03886246 names 20 study sites across 3 states, led by Other, Michigan, New York.
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.
What interventions are being tested in trial NCT03886246?
The interventions under investigation include: Spesolimab (DRUG).
Who is sponsoring clinical trial NCT03886246?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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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