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 Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
- Conditions
- Interventions
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 90
- Registration Number
- NCT06624670
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇨🇦University of Alberta Hospital (University of Alberta), Edmonton, Alberta, Canada
🇨🇦Centre de Recherche Saint-Louis, Quebec, Canada
A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
- First Posted Date
- 2024-07-25
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 60
- Registration Number
- NCT06520514
- Locations
- 🇧🇪
SGS Life Science Services - Clinical Research, Edegem, Belgium
A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
- First Posted Date
- 2024-02-05
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 39
- Registration Number
- NCT06241573
- Locations
- 🇦🇷
Hospital Alemán, Capital Federal, Argentina
🇧🇬Medical Center "Kordis", Pleven, Bulgaria
🇯🇵Tokyo Medical University Hospital, Tokyo, Shinjuku-ku, Japan
Spesolimab in Pyoderma Gangrenosum
- First Posted Date
- 2023-10-23
- Last Posted Date
- 2024-05-02
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Target Recruit Count
- 20
- Registration Number
- NCT06092216
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
- First Posted Date
- 2023-08-28
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 42
- Registration Number
- NCT06013969
- Locations
- 🇲🇾
Hospital Pulau Pinang-Pulau Pinang-21953, Georgetown Pulau Pinang, Malaysia
🇪🇸Hospital Vall d'Hebron-Barcelona-47683, Barcelona, Spain
🇺🇸AXIS Clinicals, Fargo, North Dakota, United States
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
- First Posted Date
- 2023-01-04
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 40
- Registration Number
- NCT05670821
- Locations
- 🇯🇵
Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan
An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
- First Posted Date
- 2022-02-14
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 39
- Registration Number
- NCT05239039
- Locations
- 🇨🇳
Tianjin Medical University General Hospital, Tianjin, China
🇨🇳Beijing Friendship Hospital, Beijing, China
🇨🇳West China Hospital, Chengdu, China
An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
- First Posted Date
- 2022-01-20
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 11
- Registration Number
- NCT05200247
- Locations
- 🇯🇵
Tokyo Medical University Hospital, Tokyo, Shinjuku-ku, Japan
🇯🇵Tohoku University Hospital, Miyagi, Sendai, Japan
🇯🇵Jichi Medical University Hospital, Tochigi, Shimotsuke, Japan
A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
- First Posted Date
- 2021-08-19
- Last Posted Date
- 2023-06-26
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 5
- Registration Number
- NCT05013385
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇨🇦Heritage Medical Research Clinic, Calgary, Alberta, Canada
🇸🇪Sahlgrenska Universitetssjukhuset, Mölndal, Mölndal, Sweden
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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.