lutikizumab (ABT 981) / AbbVie - LARVOL DELTA

Characterization of the IHS4 Response to Lutikizumab Treatment in Biologic-Naïve Patients With Moderate-to-Severe Hidradenitis Suppurativa (HS) (AAD 2026) - "In biologic-naïve adults with moderate-to-severe HS, lutikizumab 300 mg EW improved IHS4, as well as AN and draining tunnel counts over 16 weeks. These results support further investigation of lutikizumab in HS."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology

Lutikizumab in Adults With Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure: A Phase 2 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P2 | "In this phase 2 randomized clinical trial, lutikizumab, 300 mg, every week and 300 mg every other week showed positive treatment effects vs placebo in a hard-to-treat moderate to severe HS population that experienced anti-TNF therapy failure. ClinicalTrials.gov Identifier: NCT05139602."

Clinical • Journal • P2 data • Cardiovascular • Dermatology • Hematological Disorders • Hidradenitis Suppurativa • Immunology • Infectious Disease • Neutropenia • Oncology • Pain

M25-056: A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis (clinicaltrialsregister.eu) - P1/2 | N=108 | Recruiting | Sponsor: AbbVie Deutschland GmbH & Co. KG

New P1/2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=83 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Jan 2026 ➔ Dec 2027 | Trial primary completion date: Jan 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology

Operational Updates (Investing.com) - "Lutikizumab and RINVOQ: Phase II data in HS expected by the end of the year; SKYRIZI subcutaneous: Data expected this year; Alpha-4 beta-7 and lutikizumab combination: Readout expected this year; TL1A combinations with SKYRIZI: To start later this year; TREM1: Proof of concept data expected late this year or early next year."

Clinical data • New trial • Hidradenitis Suppurativa • Inflammatory Bowel Disease

Evaluating the promotion of biomechanical changes in osteoarthritis treated with lutikizumab: a systematic review and meta-analysis. (PubMed, Postgrad Med) - "Meta-analysis showed that compared with the control group, lutikizumab intervention had more gains, IL-α (0.3 mg/kg, Q2W, week2) (MD = -0.67, 95% CI [-1.25,-0.09]; Z = 2.26; p = 0.02), IL-1β (3 mg/kg,Q2W,week2) (MD = -0.58, 95% CI [-1.14, -0.02]; Z = 2.03; p = 0.04) and hsCRP (200 mg,Q2W,week8) (MD = -1.79, 95% CI [-2.09, -1.50]; Z = 11.80; p < 0.00001). Reducing the OA process with lutikizumab provides a theoretical basis for further investigation of the function of lutikizumab in patients with OA.IL-1 is not only an inflammatory mediator in osteoarthritis, but also a key molecule connecting biomechanical abnormalities and tissue damage.IL-1 inhibitors precisely regulate the spatiotemporal expression of IL-1, and individualize the biomechanical intervention regimens or combination of multiple interventions to achieve optimal therapeutic effects."

Journal • Retrospective data • Immunology • Osteoarthritis • Pain • Rheumatology • CRP • IL1B

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=156 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2028 ➔ Sep 2027 | Trial primary completion date: Apr 2028 ➔ Sep 2027

Adverse events • Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Next-Generation Therapies for Hidradenitis Suppurativa: Recent FDA Approvals and a Look at Clinical Trial Landscape (EADV 2025) - "Over the past decade, numerous immunotherapies have been developed for a wide range of dermatologic conditions, including two recently FDA-approved treatments for HS within the last year (bimekizumab and secukinumab)2,3...Sonelokimab, another IL-17A/F inhibitor, is currently in a recruiting phase 3 trial...Other cytokine-targeting agents are lutikizumab (IL-1α/IL-1β inhibitor), spesolimab (anti-IL-36R), and anifrolumab (type I interferon receptor antagonist)...Agents targeting the JAK-STAT pathway include the JAK1 inhibitors povorcitinib, upadacitinib, and ruxolitinib, as well as deucravacitinib, a tyrosine kinase 2 inhibitor; all are currently under investigation for HS...Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, also showed promising results, with 72.7% of patients reaching the HiSCR endpoint at week 167. Brensocatib, a dipeptidyl-peptidase 1 inhibitor, is currently being evaluated in a recruiting phase 3 trial... The last decade has brought a wave..."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IFNAR2 • IL17A • IL1B • TYK2

A Phase 2 Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lutikizumab in Biologic-Naïve Adult Patients With Moderate-To-Severe Hidradenitis Suppurativa (EADV 2025) - "In this moderate-to-severe HS patient population that is naive to biologic therapy, treatment with luti 300 mg EW was well-tolerated and showed positive efficacy results at Week 16. These results support further investigation of lutikizumab to address the unmet needs of patients with moderate-to-severe HS."

Clinical • P2 data • Cardiovascular • Dermatology • Herpes Zoster • Hidradenitis Suppurativa • Immunology • Infectious Disease • Respiratory Diseases • Tuberculosis • Varicella Zoster • IL1B • IL1R1

Characterization of the IHS4 Response to Lutikizumab Treatment in Patients With Moderate-to-Severe Hidradenitis Suppurativa (HS) (EADV 2025) - P2 | "In adults with moderate-to-severe HS who failed anti-TNF therapy, treatment with luti 300 mg EW and luti 300 mg EOW led to** numerically greater improvements in IHS4 score as well as in AN and draining tunnel counts, compared with PBO, over 16 weeks. These results support further investigation of luti to establish its potential to provide clinical efficacy to address the unmet needs of patients with moderate-to-severe HS."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology

AbbVie’s IL-1 asset misses mark as monotherapy in phase 2 ulcerative colitis study (FierceBiotech) - P2 | N=156 | Horizon (NCT06257875) | Sponsor: AbbVie | "AbbVie is ending development of an IL-1 asset as a monotherapy in ulcerative colitis (UC) after a phase 2 study revealed insufficient efficacy results...'Lutikizumab showed numerically higher efficacy for the primary endpoint of endoscopic improvement compared to Humira, which was the control arm.'...'However, the results were not sufficiently differentiated for us to pursue it as a monotherapy in this patient population.'....'It has demonstrated strong efficacy in hidradenitis suppurativa, where phase 3 is ongoing, with data expected in 2027.'...AbbVie’s pipeline changes are relatively tame compared to other Big Pharma’s this quarter, with no whole asset terminations reported on the call."

P2 data • P3 data • Hidradenitis Suppurativa • Ulcerative Colitis

Efficacy and Safety of Medical Interventions for Moderate to Severe Hidradenitis Suppurativa: A Living Systematic Review and Network Meta-Analysis. (PubMed, JAMA Dermatol) - "Compared with placebo, the following treatments were associated with significantly higher HiSCR-50 response rates: sonelokimab, 120 mg, every 4 weeks; lutikizumab, 300 mg, every 2 weeks; adalimumab, 40 mg, once per week; sonelokimab, 240 mg, every 2 weeks; bimekizumab, 320 mg, every 2 weeks; povorcitinib, 15 mg, once per day; bimekizumab, 320 mg, every 4 weeks; secukinumab, 300 mg, every 4 weeks; and secukinumab, 300 mg, every 2 weeks. The percentage of patients discontinuing treatment due to adverse events ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab (40 mg, once per week) groups, and 0% to 15% (ropsacitinib) in the other active treatment groups. This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS in the absence of head-to-head trials."

Clinical • Journal • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Lutikizumab in Neoadjuvant Treatment of Early-Stage TNBC (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Xijing Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables. (PubMed, J Pharmacokinet Pharmacodyn) - "The diffusion dimensionality models were challenged with previously published subcutaneous absorption data for 13 antibody drugs and insulin lispro, and the long-acting injectable antipsychotic drugs: subcutaneous Perseris™, intramuscular Invega Sustenna®, Risperdal Consta®, and olanzapine...Three antibodies (CNTO5825, ACE910 and ustekinumab) were best described by the 2-dimensional diffusion equation. The 2- and 3-dimensional diffusion equations were equivalent for ABT981, guselkumab, adalimumab, nemolizumab, omalizumab, and secukinumab. Golimumab, DX2930, AMG139, and mepolizumab were best described by the 3-dimensional diffusion equation. All the long-acting antipsychotic dosage forms except Risperdal Consta were modeled satisfactorily. Diffusion dimensionality models are a parsimonious and effective approach for modeling drug absorption profiles of subcutaneously and intramuscularly administered small molecule and protein drugs and their dosage forms."

Journal • CNS Disorders

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: AbbVie | Trial completion date: Apr 2027 ➔ Apr 2028 | Trial primary completion date: Apr 2027 ➔ Apr 2028

Adverse events • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

Improvement in Draining Tunnels in Response to Lutikizumab Treatment in Adult Patients with Moderate-to-Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (AAD 2025) - "In this hard-to-treat HS patient population, treatment with lutikizumab resulted in greater numerical improvements in dTs than placebo."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology

Advances and Challenges in the Pursuit of Disease-Modifying Osteoarthritis Drugs: A Review of 2010-2024 Clinical Trials. (PubMed, Biomedicines) - " Eleven DMOAD candidates are reviewed and critically analyzed for their potential benefit in OA treatment-Lorecivivint (SM04690), TissueGene-C, Cindunistat (SD-6010), Sprifermin, UBX0101, TPX-100, GLPG1972/S201086, Lutikizumab (ABT-981), SAR113945, MIV-711, and LNA043-and relevant challenges to their development are discussed. Six DMOADs have demonstrated statistically significant evidence of a structural or symptomatic benefit without major safety concerns in phase II and III randomized controlled trials post-2010."

Journal • Review • Developmental Disorders • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Nonsurgical Knee Osteoarthritis Treatments for Reducing Inflammation as Measured on MRI Scans: A Systematic Review of Randomized Controlled Trials. (PubMed, Orthop J Sports Med) - "Statistically significant group differences in favor of treatment were seen in changes in pain after lutikizumab (anti-interleukin-1α/β dual variable domain immunoglobulin; SRM, 0.22; P = .050), allogenic human chondrocytes transduced with retroviral vector encoding transforming growth factor-β1 (P = .0119 at 12 weeks, P = .120 at 52 weeks, and P = .0074 at 72 weeks), and Curcuma longa (turmeric; SRM, 0.35; P = .039 on the visual analog scale for pain and SRM, 0.47; P = .006 on the Western Ontario and McMaster Universities Osteoarthritis Index pain subscore)...Only vitamin D and exercise therapy were found to improve pain and synovitis after treatment in this review. Further research is needed to validate these findings and investigate alternative treatments for reducing pain and synovitis in persons with knee OA."

Journal • Review • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • TGFB1

A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: AbbVie

Immunomodulating • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology