GSK1070806 / GSK - LARVOL DELTA

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=199 | Recruiting | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Patient-Level Clinical Response Rates to GSK1070806, an Anti–IL-18 Monoclonal Antibody, in Moderate-to-Severe Atopic Dermatitis (AD): A Randomized, Double-Blind, Placebo-Controlled Study (AAD 2025) - P1 | "A single GSK1070806 dose may benefit patients with moderate-to-severe AD as early as Week 4, with increased, clinically meaningful response rates observed at Week 12. These findings build on the primary clinical response analysis and demonstrate GSK1070806's promise as a novel AD treatment."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL18

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=175 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Aug 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Very Early-Onset IBD-Associated IL-18opathy Treated with an Anti-IL-18 Antibody. (PubMed, J Clin Med) - " A four-year-old girl with recalcitrant VEOIBD from six weeks old due to an IL-18opathy, characterised by high blood IL-18 concentration, responded to therapy with a novel neutralising anti-IL-18 antibody (GSK1070806)... VEOIBD can be associated with evidence of an underlying IL18opathy and responds to anti-IL-18 antibody therapy. IL-18 should be measured in patients with IBD unresponsive to conventional treatments, and, if elevated, anti-IL-18 antibody therapy should be considered as a potential therapy."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL18

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=159 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=175 | Recruiting | Sponsor: GlaxoSmithKline | Trial primary completion date: Apr 2025 ➔ Aug 2024

Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effects of anti–IL-18 monoclonal antibody GSK1070806 on skin transcriptomics in moderate-to-severe AD: Biomarker analyses from a randomised, double-blind, placebo-controlled trial (EADV 2024) - P1 | "Although this study is small, these data suggest GSK1070806 can modulate a broad range of mechanisms associated with AD that are not limited to type 2 immunity. These findings should be explored further to elucidate the mechanism of action of GSK1070806 in AD. A Phase 2b study investigating the safety and efficacy of GSK1070806 is ongoing."

Biomarker • Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • IFNG • IL17A • IL18 • IL6 • TNFA

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=158 | Not yet recruiting | Sponsor: GlaxoSmithKline

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

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=175 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Phase classification: P2b ➔ P2 | Trial completion date: Sep 2025 ➔ Jun 2025

Enrollment open • Phase classification • Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy, Safety, and Tolerability of GSK1070806, an Anti–IL-18 Monoclonal Antibody, in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study (ISDS 2023) - P1 | "This study compared the efficacy, safety and patient-reported outcomes (PROs) of a single IV infusion of GSK1070806, an anti–IL-18 monoclonal IgG1 antibody, versus placebo in patients with AD. This multicentre, randomised, double-blind, parallel-group study (NCT04975438) recruited adults with moderate-to-severe AD and included both patients naïve to biologic treatment and Janus kinase inhibitors and patients deemed inadequate respondersor intolerant to dupilumab. GSK1070806 demonstrated a sustained efficacy response for up to 24 weeks after a single IV injection. GSK1070806 has the potential to become a promising treatment option for patients with AD for whom topical therapies are not effective or appropriate."

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL18

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL18

Characterisation of GSK1070806, an anti-IL-18 monoclonal antibody (EADV 2023) - "GSK1070806 is therefore a potent neutralising anti-IL18 antibody with considerable therapeutic potential in a range of inflammatory disease. The antibody has been previously evaluated in healthy and obese subjects, patients with type 2 diabetes and patients undergoing renal transplantation. GSK1070806 has been recently assessed in a Phase 1B clinical study in patients with moderate-to severe atopic dermatitis."

Atopic Dermatitis • Dermatitis • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Nephrology • Obesity • Rheumatoid Arthritis • Rheumatology • Transplantation • Type 2 Diabetes Mellitus • IFNG • IL18

Efficacy, Safety, and Tolerability of GSK1070806, an Anti-IL-18 Monoclonal Antibody, in Patients with Moderate to Severe Atopic Dermatitis: A Phase 1b, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study (EADV 2023) - "Two groups were recruited: patients naïve to biologic treatment and Janus kinase [JAK] inhibitors (BN group), and patients who were inadequate responders (after ≥16 weeks treatment), or intolerant, to dupilumab (Dupi-IR group). A single 2mg/kg IV infusion of GSK1070806 demonstrated a positive treatment effect on the EASI score and PRO measures of itch and QoL, which was sustained for at least 12 weeks. There were no safety concerns. GSK1070806 may be a promising future treatment option for patients with AD for whom topical therapies are not effective or appropriate."

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL18

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=175 | Not yet recruiting | Sponsor: GlaxoSmithKline | N=300 ➔ 175

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=300 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2b trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2024 ➔ Dec 2023 | Trial primary completion date: Oct 2023 ➔ Jul 2023

Enrollment open • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL18

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive (clinicaltrials.gov) - P1 | N=38 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL18

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: GlaxoSmithKline

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

CDAID: A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P1/2; N=5; Completed; Sponsor: University of Birmingham; Recruiting ➔ Completed; N=30 ➔ 5

Clinical • Enrollment change • Trial completion • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP

A pilot study evaluating GSK1070806 inhibition of interleukin-18 in renal transplant delayed graft function. (PubMed, PLoS One) - P2 | "Overall, using a Bayesian design and extensive PBPK dose modeling with only a small sample size, it was deemed unlikely that GSK1070806 would be efficacious in preventing DGF in the enrolled DCD transplant population."

Clinical • Journal • Acute Kidney Injury • Nephrology • Transplantation