lutikizumab (ABT 981) / AbbVie - LARVOL DELTA

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

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology

Network Meta-Analysis of Efficacy and Safety of Medical Interventions for Hidradenitis Suppurativa (SHSA 2024) - "Compared with placebo, the following treatments had significantly higher HiSCR-50 response rates: sonelokimab 120mg Q4W, lutikizumab 300mg Q2W, adalimumab 40mg QW, sonelokimab 240mg Q2W, bimekizumab 320mg Q2W, povorcitinib 15mg QD, bimekizumab 320mg Q4W, secukinumab 300mg Q4W, and secukinumab 300mg Q2W. Specific numerical results and figures will be presented if accepted. Discussion In the absence of head-to-head active-comparator trials, this analysis may help inform treatment decisions for clinicians and patients with HS."

Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

Depth of the efficacy response to lutikizumab treatment in moderate-to-severe hidradenitis suppurativa (HS) (EADV 2024) - P2 | "In a hard-to-treat patient population, treatment with luti 300 mg EW and luti 300 mg EOW provides efficacy responses at deep levels at week 16 compared to placebo, as demonstrated by HiSCR 75/90 response rates and IHS4-55/75/90 response rates. These results support further investigation of the clinical efficacy of lutikizumab as a potential treatment option for patients with moderate-to-severe HS."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

Depth of the Efficacy Response to Lutikizumab Treatment in Moderate-to-Severe Hidradenitis Suppurativa (HS) (EADV 2024) - P2 | "In a hard-to-treat patient population, treatment with luti 300 mg EW and luti 300 mg EOW provides efficacy responses at deep levels at week 16 compared to placebo, as demonstrated by HiSCR 75/90 response rates and IHS4-55/75/90 response rates. These results support further investigation of the clinical efficacy of lutikizumab as a potential treatment option for patients with moderate-to-severe HS."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab in Adult Patients with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (EADV 2024) - "In this hard-to-treat moderate-to-severe HS patient population that has failed anti-TNF therapy, lutikizumab 300 mg EW and 300 mg EOW showed positive results versus PBO."

Clinical • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2 | N=500 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2 | N=500 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Does Sex Affect the Efficacy of Systemic Pharmacological Treatments of Pain in Knee Osteoarthritis? (IASP 2024) - " Of 4574 citations screened, 9 studies (5201 participants) met inclusion criteria, analyzing drugs including duloxetine, etoricoxib, tapentadol, naproxcinod, lutikizumab, and rofecoxib. Available evidence is insufficient to evaluate differences in the analgesic response to pharmacological treatments of knee osteoarthritis between males and females. Current studies are limited by infrequent reporting of results by sex, small sample sizes, and insufficient statistical power. Our findings emphasize the need for more comprehensive research incorporating sex-stratified reporting and analysis to allow for future meta-analyses to determine whether sex-based differences exist."

Clinical • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • CRP

A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: AbbVie

Biomarker • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=1280 | Not yet recruiting | Sponsor: AbbVie

New P3 trial • Dermatology • Hidradenitis Suppurativa • Immunology

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 | Initiation date: Oct 2024 ➔ Mar 2024

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

Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion

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 | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024 ➔ Oct 2024

Adverse events • Enrollment open • Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab in Adult Patients with Moderate to Severe Hidradenitis Suppurativa Who Have (AAD 2024) - No abstract available

Clinical • Late-breaking abstract • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology

Does sex affect the efficacy of systemic pharmacological treatments of pain in knee osteoarthritis? A systematic review. (PubMed, Osteoarthr Cartil Open) - "9 studies (5201 participants) met inclusion criteria, analyzing drugs including duloxetine, etoricoxib, tapentadol, naproxcinod, lutikizumab, and rofecoxib. Current evidence does not support the existence of sex differences in the analgesic efficacy of systemic knee osteoarthritis treatments. However, this conclusion is substantially limited by the paucity of sex-specific reporting of results or subgroup analyses in most primary studies, emphasizing the need for future research to report on sex-stratified data to allow for comprehensive, personalized treatment strategies."

Journal • Review • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology