Lutikizumab Clinical Bispecific

Antibody Information

Entry ID	212
INN	Lutikizumab
Status	Clinical
Drug code(s)	ABT-981
Brand name	None
mAb sequence source	mAb humanized/human
General Molecular Category	Bispecific
Format, general category	Appended Ig
Format details	2+2 symmetric, DVD-Ig
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-1 alpha, IL-1 beta
Indications of clinical studies	Psoriatic Arthritis, Ulcerative colitis, Hidradenitis Suppurativa, Osteoarthritis
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2011
Start of Phase 2	April 15, 2014
Start of Phase 3	June 27, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	AbbVie
Licensee/Partner	None
Comments about company or candidate	NCT06865105 Phase 2 in PsA due to start in Apr 2025. NCT06468228 Phase 3 in Hidradenitis Suppurativa started in June 2024. NCT06257875 Phase 2 in UC due to start in Mar 2024 Dec 2021: Phase 2 (NCT05139602) in Hidradenitis Suppurativa started in Dec 2021 still recruiting as of Feb 2023. 2018: All studies of ABT-981 listed on clinicaltrials.gov are completed and it is no longer listed in AbbVie’s pipeline accessed 2/2/2018. Assumed to be terminated
Full address of company	North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/

Description/comment

Tetravalent. Humanized mouse Fab + human Fab, cloned from B cells from a patient with autoimmune disease.
(VL-VL’-CL/VH-VH’-CH1)2-Fc

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None