Spesolimab
- Generic Name
- Spesolimab
- Brand Names
- Spevigo
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 2097104-58-8
- Unique Ingredient Identifier
- 5IB2J79MCX
- Background
Spesolimab is an interleukin-36 (IL-36) receptor antagonist. It is a humanized monoclonal immunoglobulin G1 antibody that was produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The biosimilar of the drug, spesolimab-sbzo, was first approved by the FDA in September 2022 to treat generalized pustular psoriasis flares. Spesolimab works...
- Indication
Spesolimab is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.
- Associated Conditions
- Generalized Pustular Psoriasis (GPP)
- Associated Therapies
- Monotherapy
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
- First Posted Date
- 2020-07-30
- Last Posted Date
- 2024-03-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 108
- Registration Number
- NCT04493424
- Locations
- 🇵🇱
Dermoklinika medical center, Lodz, Lodz, Poland
🇩🇪Universitätsklinikum Frankfurt, Frankfurt am Main, Germany
🇩🇪Charité - Universitätsmedizin Berlin, Berlin, Germany
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
- First Posted Date
- 2020-05-22
- Last Posted Date
- 2023-12-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 123
- Registration Number
- NCT04399837
- Locations
- 🇩🇪
Universitätsklinikum Bonn AöR, Bonn, Germany
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
🇩🇪Klinikum Oldenburg AöR, Oldenburg, Germany
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
- First Posted Date
- 2020-04-24
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 12
- Registration Number
- NCT04362254
- Locations
- 🇧🇪
Centre Hospitalier Universitaire de Liège, Liège, Belgium
🇳🇱Amsterdam UMC, Locatie AMC, Amsterdam, Netherlands
🇧🇪UZ Leuven, Leuven, Belgium
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
- First Posted Date
- 2019-09-11
- Last Posted Date
- 2022-07-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 14
- Registration Number
- NCT04086121
- Locations
- 🇺🇸
The Indiana Clinical Trials Center, PC, Plainfield, Indiana, United States
🇯🇵Tokyo Medical University Hachioji Medical Center, Tokyo, Hachioji, Japan
🇺🇸Clinical Physiology Associates, Fort Myers, Florida, United States
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
- First Posted Date
- 2019-07-11
- Last Posted Date
- 2022-07-28
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 152
- Registration Number
- NCT04015518
- Locations
- 🇯🇵
Shiga University of Medical Science Hospital, Shiga, Otsu, Japan
🇯🇵Teikyo University Hospital, Tokyo, Itabashi-ku, Japan
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
- First Posted Date
- 2019-03-22
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 132
- Registration Number
- NCT03886246
- Locations
- 🇫🇷
HOP Robert Debré, Reims, France
🇯🇵Tokyo Medical University Hachioji Medical Center, Tokyo, Hachioji, Japan
🇪🇸Hospital Sant Joan de Déu, Esplugues Del Llobregat, Spain
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
- First Posted Date
- 2018-12-20
- Last Posted Date
- 2022-03-09
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 53
- Registration Number
- NCT03782792
- Locations
- 🇨🇳
Tianjin Medical University General Hospital, Tianjin, China
🇫🇷HOP Robert Debré, Reims, France
🇹🇳Hedi Chaker Hospital, Department of Dermatology, Tunisia, Tunisia
A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
- First Posted Date
- 2018-11-26
- Last Posted Date
- 2024-02-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 27
- Registration Number
- NCT03752970
- Locations
- 🇦🇹
AKH - Medical University of Vienna, Wien, Austria
🇧🇪UZ Leuven, Leuven, Belgium
🇩🇪Universitätsklinikum Erlangen, Erlangen, Germany
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
- First Posted Date
- 2018-08-27
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 79
- Registration Number
- NCT03648541
- Locations
- 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸University of Chicago, Chicago, Illinois, United States
🇺🇸Southern Star Research Institute, LLC, San Antonio, Texas, United States
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
- First Posted Date
- 2018-03-29
- Last Posted Date
- 2021-06-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 98
- Registration Number
- NCT03482635
- Locations
- 🇨🇦
University of Manitoba - Health Sciences Centre, Winnipeg, Manitoba, Canada
🇷🇺FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien., Irkutsk, Russian Federation
🇩🇪Medizinische Hochschule Hannover, Hannover, Germany
Drug Development Updates
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