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
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
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
- First Posted Date
- 2017-04-21
- Last Posted Date
- 2021-11-09
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 22
- Registration Number
- NCT03123120
- Locations
- 🇩🇰
Aalborg Sygehus Syd, Aalborg, Denmark
🇩🇰Odense University Hospital, Odense, Denmark
🇪🇸Hospital Puerta de Hierro, Majadahonda, Spain
Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects
- First Posted Date
- 2017-04-21
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 32
- Registration Number
- NCT03123094
- Locations
- 🇰🇷
Inje University Busan Paik Hospital, Busan, Korea, Republic of
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2020-12-22
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 8
- Registration Number
- NCT03100864
- Locations
- 🇬🇧
Addenbrooke's Hospital, Cambridge, United Kingdom
🇩🇪Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany
🇧🇪UZ Leuven, Leuven, Belgium
Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
- First Posted Date
- 2016-12-01
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 7
- Registration Number
- NCT02978690
- Locations
- 🇲🇾
Hospital Sultanah Aminah, Johor Bahru, Malaysia
🇫🇷HOP Saint-Louis, Paris, France
🇰🇷Pusan National Univ. Hosp, Busan, Korea, Republic of
Drug Development Updates
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