GSK3858279 / GSK - LARVOL DELTA

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=147 | Terminated | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Terminated; The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.

Trial termination • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - P2 | N=314 | Terminated | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Terminated; The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.

Trial termination • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=145 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=240 ➔ 145 | Trial completion date: Oct 2025 ➔ Jan 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy, safety and tolerability of GSK3858279, an anti-CCL17 monoclonal antibody and analgesic, in healthy volunteers and patients with knee osteoarthritis pain: a phase I, randomised, double-blind, placebo-controlled, proof-of-mechanism and proof-of-concept study. (PubMed, Ann Rheum Dis) - "Median CFB (95% CrI) for GSK3858279 versus placebo in WOMAC pain and function scores were -1.41 (-2.35, -0.46) and -1.29 (-2.28, -0.29), respectively, at week 8. Overall, 72% (26/36; part A) and 88% (21/24; part B) of participants receiving GSK3858279 experienced adverse events (AEs); with nasopharyngitis being the most common in part A and injection site reactions in part B. No serious AEs or deaths were observed.GSK3858279 improved pain intensity and WOMAC pain and function scores in adults with knee OA pain and demonstrated favourable safety and tolerability in both healthy participants and adults with knee OA pain."

Journal • Immunology • Infectious Disease • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=263 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=420 ➔ 263 | Trial completion date: Oct 2025 ➔ Nov 2024 | Trial primary completion date: Jul 2025 ➔ Aug 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Randomized, placebo-controlled study on the effects of intravenous GSK3858279 (anti-CCL17) on a battery of evoked pain tests in healthy participants. (PubMed, Clin Transl Sci) - P1 | "All drug-related adverse events were mild in intensity and caused no discontinuations. The absence of an efficacy signal in this acute pain model does not preclude efficacy in chronic pain states."

Clinical • Journal • Pain

Efficacy, Safety, Pharmacokinetics and Immunogenicity of Repeated Dosing of GSK3858279 in Patients with Knee Osteoarthritis: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study (ACR Convergence 2023) - P1 | "Weekly dosing for 8 weeks with GSK3858279 has clinical activity (improved pain scores) and a favourable safety profile in patients with OA knee pain. These compelling data warrant further study of the effectiveness and safety of GSK3858279 in people with OA pain. J."

Clinical • PK/PD data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Enrollment open • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=420 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Feb 2025 ➔ Jul 2025

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: GlaxoSmithKline | Initiation date: May 2023 ➔ Sep 2023

Trial initiation date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=420 | Not yet recruiting | Sponsor: GlaxoSmithKline | Initiation date: May 2023 ➔ Sep 2023

Trial initiation date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Pain

Efficacy, Safety, Pharmacokinetics and Immunogenicity of Repeated Dosing of GSK3858279 in Patients with Knee Osteoarthritis: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study (EULAR 2023) - P1 | "a 11-point numerical rating scale: 0 (no pain/difficulty) to 10 (worst imaginable pain/difficulty). WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index."

Clinical • PK/PD data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

"GSK3858279 in patients with knee OA. #Eular2023" (@NoufAhmedAlham2)

Clinical

MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=420 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Pain

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - P1 | N=97 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Sep 2022

Enrollment open • Trial completion date • Trial primary completion date • Pain

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P1 trial • Pain

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - P1; N=98; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Apr 2022 ➔ Jul 2022; Trial primary completion date: Apr 2022 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: GlaxoSmithKline; Recruiting ➔ Completed; Trial completion date: Jan 2022 ➔ Sep 2021; Trial primary completion date: Jan 2022 ➔ Sep 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Pain

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - P1; N=98; Recruiting; Sponsor: GlaxoSmithKline; Suspended ➔ Recruiting

Clinical • Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology