Amlitelimab

Summary

Amlitelimab (CHEMBL4594569) is a phase-3 clinical-stage antibody; indicated across 7 conditions including atopic eczema and asthma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 7 conditions
• Clinical trials: 21

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594569
Name	Amlitelimab
Type	Antibody
Max phase	3

Also known as: Amlitelimab, Ky-1005, KY-1005, Ky1005, KY1005, SAR-445229, SAR445229, AMLITELIMAB

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

6 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
atopic eczema	3	MONDO:0004980	EFO:0000274
asthma	2	MONDO:0004979	MONDO:0004979
alopecia areata	2	MONDO:0005340	EFO:0004192
hidradenitis	2	MONDO:0002260	MONDO:0002260
immune system disorder	1	MONDO:0005046	EFO:0000540
autoimmune disease	1	MONDO:0007179	EFO:0005809

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

Clinical trials

Total trials: 21.

Phase distribution

Phase	Trials
PHASE2	10
PHASE3	5
PHASE1	5
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05492578	PHASE2/PHASE3	ENROLLING_BY_INVITATION	Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
NCT06241118	PHASE3	RECRUITING	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
NCT06407934	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06130566	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06181435	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
NCT06224348	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
NCT05769777	PHASE2	ACTIVE_NOT_RECRUITING	Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT06033833	PHASE2	ACTIVE_NOT_RECRUITING	Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
NCT06195072	PHASE2	RECRUITING	Platform Clinical Study for Conquering Scleroderma
NCT06444451	PHASE2	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
NCT06557772	PHASE2	ACTIVE_NOT_RECRUITING	A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
NCT03754309	PHASE2	COMPLETED	A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
NCT05131477	PHASE2	COMPLETED	Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
NCT05421598	PHASE2	COMPLETED	Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
NCT06015308	PHASE2	COMPLETED	A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
NCT06118099	PHASE2	TERMINATED	Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT03161288	PHASE1	COMPLETED	A Study of KY1005 in Healthy Volunteers
NCT04449939	PHASE1	COMPLETED	A Study of Subcutaneous KY1005 in Healthy Volunteers
NCT05796479	PHASE1	COMPLETED	A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants
NCT06686628	PHASE1	COMPLETED	An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
NCT07146750	PHASE1	COMPLETED	A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

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).