Overview
Lutikizumab is under investigation in clinical trial NCT02087904 (A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Lutikizumab (ABT-981): A Comprehensive Profile of a Dual IL-1α/β Antagonist from Osteoarthritis to Hidradenitis Suppurativa
Executive Summary
Lutikizumab is an investigational, next-generation biologic agent developed by Abbott Laboratories and its successor, AbbVie, representing a significant advancement in therapeutic antibody engineering.[1] Structurally, it is a humanized, tetravalent bispecific antibody, engineered using a proprietary dual-variable domain immunoglobulin (DVD-Ig) platform.[2] This sophisticated design enables Lutikizumab to function as a potent and specific inhibitor of two distinct but related pro-inflammatory cytokines: Interleukin-1 alpha (
IL−1α) and Interleukin-1 beta (IL−1β).[5] By simultaneously neutralizing both mediators, Lutikizumab is designed to provide a more comprehensive blockade of the IL-1 signaling pathway than agents targeting a single cytokine.
The clinical development of Lutikizumab has been characterized by a critical and strategic pivot. The drug was initially investigated for the treatment of osteoarthritis (OA), a therapeutic area where the IL-1 pathway was hypothesized to play a key role. However, despite Phase 2 clinical trials demonstrating successful target engagement and biological activity, Lutikizumab failed to produce clinically meaningful improvements in pain or structural outcomes in patients with either knee or hand OA, leading to the discontinuation of the program for this indication.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/15 | Phase 2 | Recruiting | |||
2025/03/07 | Phase 2 | Recruiting | |||
2024/12/05 | Phase 2 | Recruiting | |||
2024/08/12 | Phase 2 | Recruiting | |||
2024/07/29 | Phase 2 | Recruiting | |||
2024/06/21 | Phase 3 | Recruiting | |||
2024/02/14 | Phase 2 | Active, not recruiting | |||
2023/10/05 | Phase 1 | Completed | |||
2021/12/01 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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