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 |
Target(s) | IL-1 alpha, IL-1 beta |
Indications of clinical studies | Ulcerative colitis, Hidradenitis Suppurativa, Osteoarthritis |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
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 | 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/ |
Tetravalent. Humanized mouse Fab + human Fab, cloned from B cells from a patient with autoimmune disease. (VL-VL’-CL/VH-VH’-CH1)2-Fc
Anticipated events | None |
Factor(s) contributing to discontinuation | None |