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

Clinical Trials

A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction

Phase 2

Terminated

Conditions: Fibrostenotic Crohn´s Disease

Interventions: Drug: Placebo
Drug: Spesolimab

First Posted Date: 2021-08-19

Last Posted Date: 2025-02-24

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

and more 1 locations

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Spesolimab

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

and more 18 locations

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Spesolimab - solution for infusion
Drug: Placebo matching spesolimab - solution for infusion
Drug: Spesolimab- solution for injection
Drug: Placebo matching to spesolimab- solution for injection

First Posted Date: 2021-02-21

Last Posted Date: 2024-10-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 52

Registration Number: NCT04762277

Locations: 🇺🇸
Dermatology Research Associates, Los Angeles, California, United States
🇺🇸
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States
🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 22 locations

A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Phase 2

Terminated

Conditions: Palmoplantar Pustulosis

Interventions: Drug: 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

and more 63 locations

A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis

Phase 2

Completed

Conditions: Generalized Pustular Psoriasis

Interventions: Drug: Placebo
Drug: Spesolimab

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

and more 69 locations

A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

Phase 2

Terminated

Conditions: Crohn Disease

Interventions: Drug: Spesolimab

First Posted Date: 2020-04-24

Last Posted Date: 2025-02-24

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

and more 4 locations

A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032

Phase 2

Terminated

Conditions: Dermatitis, Atopic

Interventions: Drug: Spesolimab

First Posted Date: 2019-09-11

Last Posted Date: 2025-02-24

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

and more 7 locations

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

Phase 2

Completed

Conditions: Palmoplantar Pustulosis (PPP)

Interventions: Drug: Spesolimab
Drug: Placebo

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

and more 85 locations

Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study

Phase 2

Active, not recruiting

Conditions: Generalized Pustular Psoriasis

Interventions: Drug: Spesolimab

First Posted Date: 2019-03-22

Last Posted Date: 2025-04-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 132

Registration Number: NCT03886246

Locations: 🇩🇪
Charite Universitätsmedizin Berlin KöR, Berlin, Germany
🇺🇸
Oakland Hills Dermatology, Auburn Hills, Michigan, United States
🇨🇳
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China

and more 54 locations

A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated

Phase 2

Completed

Conditions: Dermatitis, Atopic

Interventions: Drug: Placebo
Drug: BI 655130

First Posted Date: 2019-01-30

Last Posted Date: 2022-12-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 51

Registration Number: NCT03822832

Locations: 🇺🇸
Center for Dermatology and Plastic Surgery, Scottsdale, Arizona, United States
🇺🇸
University of South Florida, Tampa, Florida, United States
🇺🇸
ForCare Clinical Research, Inc., Tampa, Florida, United States

and more 20 locations

Drug Development Updates

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