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 by inhibiting the inflammatory signaling pathway of IL-36, which is often overexpressed and aberrantly overactive in generalized pustular psoriasis. Spesolimab received recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) to be granted marketing authorization in October 2022 and was finally approved in December 2022 for the treatment of flares in adult patients with generalized pustular psoriasis.
- 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 Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
- First Posted Date
- 2021-05-06
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 45
- Registration Number
- NCT04876391
- Locations
- 🇦🇺
Holdsworth House Medical Practice, Sydney, New South Wales, Australia
🇦🇺Royal Melbourne Hospital, Parkville, Victoria, Australia
🇨🇦Dr. S. K. Siddha Medicine Professional Corporation, Newmarket, Ontario, Canada
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
- 2024-12-24
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 132
- Registration Number
- NCT03886246
- Locations
- 🇺🇸
Oakland Hills Dermatology, Auburn Hills, Michigan, United States
🇺🇸Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇦🇷Hospital Italiano de Buenos Aires, Caba, Argentina
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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.