Spesolimab

Summary

Spesolimab (CHEMBL4297911) is an approved antibody (ATC L04AC22) targeting IL1RL2; indicated across 9 conditions including psoriasis and immune system disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AC22
• Targets: 1 (IL1RL2)
• Indications: 9 conditions
• Clinical trials: 27

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297911
Name	Spesolimab
Type	Antibody
Max phase	4
ATC	L04AC22

Also known as: BI 655130, BI-655130, Bi655130, BI655130, Espesolimab, Spesolimab, Spesolimab sbzo, Spesolimab-sbzo, Spevigo, SPESOLIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
IL1RL2	Interleukin-1 receptor-like 2	Binding	10.52	0.4%	Q9HB29

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): IL1RL2.

Top Reactome pathways

2 total, by targets touching each:

Pathway	Targets	Genes
Interleukin-38 signaling	1	IL1RL2
Interleukin-36 pathway	1	IL1RL2

Dominant GO biological processes

GO term	Targets
inflammatory response	1
cellular defense response	1
signal transduction	1
cell surface receptor signaling pathway	1
positive regulation of interleukin-6 production	1
innate immune response	1
positive regulation of T cell differentiation	1
regulation of inflammatory response	1
immune system process	1
cytokine-mediated signaling pathway	1
interleukin-1-mediated signaling pathway	1

Indications & clinical

Indications

9 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
psoriasis	4	MONDO:0005083	EFO:0000676
immune system disorder	4	MONDO:0005046	EFO:0000540
Crohn disease	2	MONDO:0005011	EFO:0000384
ulcerative colitis	2	MONDO:0005101	EFO:0000729
hidradenitis suppurativa	2	MONDO:0006559	EFO:1000710
Netherton syndrome	2	MONDO:0009735	MONDO:0009735
pyoderma	2	MONDO:0002922	HP:0000999

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 27.

Phase distribution

Phase	Trials
PHASE2	15
PHASE1	4
PHASE2/PHASE3	3
PHASE3	3
PHASE4	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06013969	PHASE4	ACTIVE_NOT_RECRUITING	A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
NCT06624670	PHASE3	RECRUITING	A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
NCT03482635	PHASE2/PHASE3	COMPLETED	BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
NCT05200247	PHASE3	COMPLETED	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
NCT05239039	PHASE3	COMPLETED	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
NCT05819398	PHASE2/PHASE3	COMPLETED	Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
NCT06241573	PHASE2/PHASE3	TERMINATED	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
NCT03886246	PHASE2	ACTIVE_NOT_RECRUITING	Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
NCT03100864	PHASE2	COMPLETED	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
NCT03123120	PHASE2	COMPLETED	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
NCT03648541	PHASE2	COMPLETED	BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
NCT03752970	PHASE2	COMPLETED	A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn’s Disease
NCT03782792	PHASE2	COMPLETED	Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
NCT03822832	PHASE2	COMPLETED	A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
NCT04015518	PHASE2	COMPLETED	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
NCT04086121	PHASE2	TERMINATED	A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
NCT04362254	PHASE2	TERMINATED	A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn’s Disease Who Took Part in Previous Trials
NCT04399837	PHASE2	COMPLETED	A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
NCT04493424	PHASE2	TERMINATED	A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
NCT04876391	PHASE2	COMPLETED	A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
NCT05013385	PHASE2	TERMINATED	A Study to Test Whether Spesolimab Helps People With Crohn’s Disease Who Have Symptoms of Bowel Obstruction
NCT06092216	PHASE2	TERMINATED	Spesolimab in Pyoderma Gangrenosum
NCT02978690	PHASE1	COMPLETED	Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
NCT03100903	PHASE1	COMPLETED	Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects
NCT03123094	PHASE1	COMPLETED	Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects
NCT06520514	PHASE1	COMPLETED	A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
NCT05670821	Not specified	COMPLETED	PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).