AMG 329 / Amgen - LARVOL DELTA

Development and preclinical characterization of AMG 329: a human antibody neutralizing FLT3 ligand. (PubMed, MAbs) - "Disruption of the FLT3/FLT3L signaling pathway presents a new potential therapeutic approach to treat autoimmune and inflammatory diseases. AMG 329 is a selective human monoclonal antibody antagonist of FLT3L that is currently being investigated in clinical studies."

Journal • Preclinical • Immunology • Oncology • Sarcoma • Solid Tumor • FLT3

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of AMG 329, a Monoclonal Antibody, in Conventional and Plasmacytoid Dendritic Cell-Mediated Rheumatic Diseases (ACR Convergence 2024) - "When added to SOC therapy, AMG 329 had an acceptable safety profile in adult pts with stable cDC- and pDC-mediated rheumatic diseases. The PK profile of AMG 329 is consistent with a typical mAb. Reductions in pDCs, cDCs and monocytes were observed that lasted up to 12 weeks following the highest dose in the MAD cohort."

Clinical • P1 data • PK/PD data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Lupus • Oncology • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Sarcoma • Seronegative Spondyloarthropathies • Solid Tumor • Spondylarthritis • Systemic Lupus Erythematosus

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome (clinicaltrials.gov) - P2 | N=262 | Recruiting | Sponsor: Amgen | Trial primary completion date: Sep 2026 ➔ Jun 2026

Trial primary completion date • Immunology • Sjogren's Syndrome

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of AMG 329, a Monoclonal Antibody, in Conventional and Plasmacytoid Dendritic Cell-Mediated Rheumatic Diseases (EULAR 2024) - No abstract available

Clinical • P1 data • PK/PD data • Rheumatology

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome (clinicaltrials.gov) - P2 | N=262 | Recruiting | Sponsor: Horizon Therapeutics Ireland DAC | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Sjogren's Syndrome

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome (clinicaltrials.gov) - P2 | N=262 | Not yet recruiting | Sponsor: Horizon Therapeutics Ireland DAC

New P2 trial • Immunology • Sjogren's Syndrome

VIB1116.P1.S1: A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Viela Bio (acquired by Horizon Therapeutics) | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Jul 2023 | Trial primary completion date: Nov 2023 ➔ Jul 2023

Trial completion • Trial completion date • Trial primary completion date • Rheumatology

VIB1116.P1.S1: A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases (clinicaltrials.gov) - P1 | N=73 | Active, not recruiting | Sponsor: Viela Bio (acquired by Horizon Therapeutics) | Trial completion date: May 2023 ➔ Nov 2023 | Trial primary completion date: May 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date • Rheumatology

VIB1116.P1.S1: A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases (clinicaltrials.gov) - P1 | N=73 | Active, not recruiting | Sponsor: Viela Bio (acquired by Horizon Therapeutics) | Recruiting ➔ Active, not recruiting

Enrollment closed • Rheumatology

VIB1116.P1.S1: A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Viela Bio (acquired by Horizon Therapeutics) | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Rheumatology

VIB1116.P1.S1: A Study of Single Ascending Doses of VIB1116 in Rheumatic Diseases (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Viela Bio

Clinical • New P1 trial • Rheumatology