Rocatinlimab

Summary

Rocatinlimab (CHEMBL4594567) is a phase-3 clinical-stage antibody targeting TNFRSF4; indicated across 2 conditions including atopic eczema and ulcerative colitis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (TNFRSF4)
• Indications: 2 conditions
• Clinical trials: 16

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594567
Name	Rocatinlimab
Type	Antibody
Max phase	3

Also known as: AMG 451, AMG-451, AMG451, Khk-4083, KHK-4083, Khk4083, KHK4083, KLK4083, Rocatinlimab, ROCATINLIMAB

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
TNFRSF4	OX40	Inhibition		0.1%	P43489

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): TNFRSF4.

Top Reactome pathways

1 total, by targets touching each:

Pathway	Targets	Genes
TNFs bind their physiological receptors	1	TNFRSF4

Dominant GO biological processes

GO term	Targets
negative regulation of transcription by RNA polymerase II	1
positive regulation of immunoglobulin production	1
inflammatory response	1
immune response	1
positive regulation of B cell proliferation	1
T cell proliferation	1
tumor necrosis factor-mediated signaling pathway	1
symbiont entry into host cell	1

Indications & clinical

Indications

2 indications (0 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
atopic eczema	3	MONDO:0004980	EFO:0000274
ulcerative colitis	1	MONDO:0005101	EFO:0000729

Clinical trials

Total trials: 16.

Phase distribution

Phase	Trials
PHASE3	8
PHASE1	4
PHASE2	3
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05882877	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT06527404	PHASE3	ACTIVE_NOT_RECRUITING	A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
NCT05398445	PHASE3	COMPLETED	A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
NCT05633355	PHASE3	COMPLETED	A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05651711	PHASE3	COMPLETED	A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
NCT05704738	PHASE3	COMPLETED	A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05724199	PHASE3	COMPLETED	A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05899816	PHASE3	COMPLETED	A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
NCT06376045	PHASE2	ACTIVE_NOT_RECRUITING	A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
NCT02647866	PHASE2	COMPLETED	Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
NCT03703102	PHASE2	COMPLETED	Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
NCT02985593	PHASE1	COMPLETED	A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis
NCT03096223	PHASE1	COMPLETED	A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis
NCT06214481	PHASE1	COMPLETED	A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants
NCT06438263	PHASE1	COMPLETED	A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
NCT05891119	EARLY_PHASE1	COMPLETED	Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis

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).