AZD1163 / AstraZeneca - LARVOL DELTA

LaunchPAD-RA: A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

LaunchPAD-RA: A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: AstraZeneca

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

AZD1163, a Novel Bispecific Human Antibody Targeting PAD2/4 Enzymes Responsible for Generating Citrullinated Protein Auto-antigens in Rheumatoid Arthritis, Demonstrates Dose-dependent Inhibition of Systemic PAD Activity in Healthy Volunteers (ACR Convergence 2025) - P1 | "This first-in-human study of a novel bispecific antibody inhibiting PAD 2 and 4 enzymes, demonstrated that Q2W dosing of AZD1163 was well tolerated in healthy volunteers, with favorable PK characteristics in the dose range studied. Target engagement was demonstrated by inhibition of PAD2/4 activity ex vivo in plasma. Results generated from this Phase I study, supports the further evaluation of AZD1163 in patients with RA."

Clinical • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=129 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=99 ➔ 129

Enrollment change • Enrollment closed

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=99 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2026 ➔ Oct 2025 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date

Blockade of Soluble and Cell Surface PAD Activity Prevents the Generation of Citrullinated Autoantigens Recognized by RA Patients' Serum (ACR Convergence 2024) - P1 | "AZD1163 is a bi-specific anti-PAD2/4 antibody in phase I clinical trials (NCT06103877) for the treatment of RA. AZD1163 blocks the enzymic activity of soluble and membrane PAD2 and PAD4 preventing protein citrullination. Targeting the generation of the citrullinated autoantigens that drive autoimmunity and chronic inflammatory responses in the joints is a novel approach for the treatment of RA."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=99 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2025 ➔ Apr 2026

Trial completion date

AZD1163 - FIRST-IN-CLASS ANTI-PAD2/4 BI-SPECIFIC ANTIBODY TO INHIBIT AUTOANTIGEN FORMATION IN RHEUMATOID ARTHRITIS (EULAR 2024) - "We describe generation of a novel potent bi-specific anti-PAD2/4 antibody (AZD1163) that inhibits neutrophil PADs, the enzymes responsible for the generation of citrullinated autoantigens in RA. Moreover, we found no evidence for neutrophil activation by this bi-specific antibody. In non-human primates, AZD1163 exhibited favourable PK/PD properties that merit progression to clinical trials."

Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=99 | Recruiting | Sponsor: AstraZeneca | N=28 ➔ 99

Enrollment change

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: AstraZeneca | N=64 ➔ 28

Enrollment change