Lutikizumab History and Updates

28 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
28
Trial Milestones
0
Pivotal Publications
Lutikizumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202220232024202520262027202820292030Trial: NCT06972446 2025-06-20 → 2027-02-28 (primary completion)Trial: NCT06865105 2025-04-11 → 2027-12-31 (primary completion)Trial: NCT06718101 2024-12-19 → 2027-05-31 (primary completion)Trial: NCT06548542 2024-09-04 → 2030-01-31 (primary completion)Trial: NCT06524635 2024-08-14 → 2027-02-28 (primary completion)Trial: NCT06468228 2024-06-27 → 2026-12-31 (primary completion)Trial: NCT06257875 2024-03-23 → 2027-09-30 (primary completion)Trial: NCT06067568 2023-09-28 → 2024-02-26 (primary completion)Trial: NCT05139602 2021-12-28 → 2027-12-31 (primary completion)today (2026-06-10)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Lutikizumab since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06468228
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppu
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06524635
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06718101
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atop
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06257875
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participant
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05139602
A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenit
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06548542
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06548542
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Past events

2025
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06865105
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06718101
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atop
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06548542
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06524635
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06468228
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppu
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06257875
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participant
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06067568
Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participan
2023
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06067568
Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participan
2021
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05139602
A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenit

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.