Ustekinumab

Summary

Ustekinumab (CHEMBL1201835) is an approved antibody (ATC L04AC05); indicated across 31 conditions including psoriasis and crohn disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AC05
• Indications: 31 conditions
• Clinical trials: 152

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201835
Name	Ustekinumab
Type	Antibody
Max phase	4
ATC	L04AC05

Also known as: CNTO 1275, CNTO-1275, Pyzchiva, Selarsdi, Stelara, Stelera, TT-20, Ustekinumab, Ustekinumab-aekn, Ustekinumab-ttwe, Uzpruvo, Wezenla

Targets

Targets

No target linkage available.

Bioactivity

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

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

31 indications (6 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
Crohn disease	4	MONDO:0005011	EFO:0000384
psoriatic arthritis	4	MONDO:0011849	EFO:0003778
immune system disorder	4	MONDO:0005046	EFO:0000540
ulcerative colitis	4	MONDO:0005101	EFO:0000729
ankylosing spondylitis	3	MONDO:0005306	EFO:0003898
dermatomyositis	3	MONDO:0016367	EFO:0000398
pouchitis	3	MONDO:0005312	EFO:0003921
colitis	3	MONDO:0005292	EFO:0003872
Takayasu arteritis	3	MONDO:0017991	EFO:1001857
juvenile idiopathic arthritis	3	MONDO:0011429	EFO:0002609
systemic lupus erythematosus	3	MONDO:0007915	MONDO:0007915
polymyositis	3	MONDO:0019127	EFO:0003063
inflammatory bowel disease	3	MONDO:0005265	EFO:0003767
atopic eczema	2	MONDO:0004980	EFO:0000274
uveitis	2	MONDO:0020283	EFO:1001231
hidradenitis suppurativa	2	MONDO:0006559	EFO:1000710
rheumatoid arthritis	2	MONDO:0008383	EFO:0000685
Behcet disease	2	MONDO:0007191	EFO:0003780
temporal arteritis	2	MONDO:0008538	EFO:1001209
primary biliary cholangitis	2	MONDO:0005388	EFO:1001486
bullous pemphigoid	2	MONDO:0019082	EFO:0007187
graft versus host disease	2	MONDO:0013730	MONDO:0013730
type 1 diabetes mellitus	2	MONDO:0005147	MONDO:0005147
multiple sclerosis	2	MONDO:0005301	MONDO:0005301
sarcoidosis	2	MONDO:0019338	MONDO:0019338
hematopoietic and lymphoid system neoplasm	2	MONDO:0002334	MONDO:0002334
hematologic disorder	2	MONDO:0005570	EFO:0005803
Sjogren syndrome	1	MONDO:0010030	EFO:0000699
ichthyosis	0	MONDO:0019269	MONDO:0019269

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

Clinical trials

Total trials: 152.

Phase distribution

Phase	Trials
PHASE3	49
Not specified	34
PHASE2	30
PHASE4	16
PHASE1	13
PHASE1/PHASE2	6
PHASE2/PHASE3	3
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04496063	PHASE4	ACTIVE_NOT_RECRUITING	USTekinumab in Fistulising Perianal Crohn’s Disease (USTAP)
NCT05270733	PHASE4	RECRUITING	Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
NCT06045754	PHASE4	RECRUITING	A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn’s Disease
NCT06520397	PHASE4	RECRUITING	Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn’s Disease
NCT06788340	PHASE4	NOT_YET_RECRUITING	MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
NCT07352566	PHASE4	NOT_YET_RECRUITING	Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT01059773	PHASE4	COMPLETED	A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
NCT01511315	PHASE4	COMPLETED	The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment
NCT01558310	PHASE4	UNKNOWN	A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis
NCT02144857	PHASE4	UNKNOWN	Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis
NCT02187172	PHASE4	COMPLETED	Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)
NCT02693470	PHASE4	UNKNOWN	The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
NCT03629379	PHASE4	COMPLETED	Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions
NCT04629196	PHASE4	TERMINATED	Induction Optimization With Stelara for Crohn’s Disease
NCT04996485	PHASE4	UNKNOWN	Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children
NCT05029921	PHASE4	COMPLETED	A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn’s Disease
NCT03466411	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease
NCT03941132	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)
NCT04524611	PHASE3	ACTIVE_NOT_RECRUITING	Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn’s Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn’s Disease (CD)
NCT05083182	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
NCT05092269	PHASE3	ACTIVE_NOT_RECRUITING	A Long-term Extension Study of Ustekinumab in Pediatric Participants
NCT05299931	PHASE3	ACTIVE_NOT_RECRUITING	An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn’s Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study
NCT05535738	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
NCT06425549	PHASE3	RECRUITING	A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
NCT06934226	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
NCT07116967	PHASE3	RECRUITING	Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
NCT07177118	PHASE3	NOT_YET_RECRUITING	Risankizumab for Fibrostenotic Crohn’s Disease Treatment
NCT00267969	PHASE3	COMPLETED	A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
NCT01008995	PHASE3	COMPLETED	A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
NCT01009086	PHASE3	COMPLETED	A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
NCT01077362	PHASE3	COMPLETED	A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
NCT01091051	PHASE3	TERMINATED	Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
NCT01550744	PHASE3	COMPLETED	A Study of Ustekinumab to Evaluate a Subject-tailored Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
NCT01708603	PHASE3	TERMINATED	P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
NCT01708629	PHASE3	TERMINATED	Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
NCT02074982	PHASE3	COMPLETED	Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
NCT02203032	PHASE3	COMPLETED	A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
NCT02437162	PHASE3	TERMINATED	A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
NCT02438787	PHASE3	TERMINATED	A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
NCT02561806	PHASE3	COMPLETED	A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

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).