Spesolimab
- Generic Name
- Spesolimab
- Brand Names
- Spevigo
- Drug Type
- Biotech
- 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 to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
- Conditions
- Pyoderma Gangrenosum
- Interventions
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 90
- Registration Number
- NCT06624670
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Medical Dermatology Specialists Phoenix, Phoenix, Arizona, United States
🇺🇸University of California Irvine, Orange, California, United States
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
- 2025-01-22
- 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
- 2025-04-29
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 39
- Registration Number
- NCT06241573
- Locations
- 🇧🇬
ASMC-IPSMC-skin and Veneral Diseases, Sofia, Bulgaria
🇺🇸Clinical Trials Research Institute, Thousand Oaks, California, United States
🇦🇷STAT Research, Caba, Argentina
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
- 2025-04-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 42
- Registration Number
- NCT06013969
- Locations
- 🇲🇾
Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
🇲🇾Hospital Putrajaya, Putrajaya, Malaysia
🇲🇾Sunway Medical Centre, Selangor Darul Ehsan, Malaysia
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
- Conditions
- Netherton Syndrome
- Interventions
- Drug: Placebo matching to spesolimab - solution for infusionDrug: Placebo matching to spesolimab - solution for injection
- First Posted Date
- 2023-05-12
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 43
- Registration Number
- NCT05856526
- Locations
- 🇨🇳
Beijing Children's Hospital, Capital Medical University, Beijing, China
🇺🇸Mission Dermatology Center, Rancho Santa Margarita, California, United States
🇺🇸Yale University School of Medicine, New Haven, Connecticut, United States
Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Drug: Placebo matching Spesolimab Formulation 1Drug: Placebo matching Spesolimab Formulation 2
- First Posted Date
- 2023-04-19
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 209
- Registration Number
- NCT05819398
- Locations
- 🇯🇵
Dokkyo Medical University Hospital, Tochigi, Shimotsuga-gun, Japan
🇺🇸First OC Dermatology, Fountain Valley, California, United States
🇺🇸Dermatology Research Associates, Los Angeles, California, United States
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
- First Posted Date
- 2023-01-04
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 52
- 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
- 2025-02-25
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.