TAbS







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 Ulcerative colitis, Hidradenitis Suppurativa, Osteoarthritis
Primary therapeutic area Immune-mediated / inflammatory disorders

Development stage information


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 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