rozibafusp alfa (AMG 570) / AstraZeneca, Amgen - LARVOL DELTA

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=244 | Completed | Sponsor: Amgen | Phase classification: P2b ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Improving resource utilisation in SLE drug development through innovative trial design. (PubMed, Lupus Sci Med) - "In this review we present the design of two innovative phase IIb studies investigating efavaleukin alfa and rozibafusp alfa for the treatment of SLE which use an adaptive study design. Furthermore, these trials can provide the required evidence to potentially serve as one of two confirmatory trials needed for regulatory approval. This can reduce the need for multiple phase III trials, the total patient requirements, person-exposure risk, and ultimately the time and cost of investigational drug development programmes."

HEOR • Journal • Review • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b | N=244 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase 1 Clinical Trials. (PubMed, Clin Pharmacol Ther) - "PK/PD analysis showed >90% RO at rozibafusp alfa ≥22.2 μg/mL (≥420-mg single dose or ≥210 mg Q2W multiple dose), with saturation occurring at higher drug concentrations. These results informed the design and dose selection of a phase 2b study assessing the safety and efficacy of rozibafusp alfa in patients with active systemic lupus erythematosus."

Journal • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • ICOS • ICOSLG

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b | N=320 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Jul 2023 | Trial primary completion date: Sep 2024 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b | N=320 | Recruiting | Sponsor: Amgen | Trial completion date: Jul 2024 ➔ Jan 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Safety and Biological Activity of Rozibafusp alfa, a Bispecific Inhibitor of Inducible Costimulator Ligand and B Cell Activating Factor, in Patients With Rheumatoid Arthritis: Results of a Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study. (PubMed, ACR Open Rheumatol) - "Multiple ascending doses of rozibafusp alfa were well tolerated, with PK and PD reflecting dual ICOSL and BAFF blockade. Findings support further clinical evaluation of rozibafusp alfa in autoimmune disease."

Clinical • Journal • P1 data • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b | N=320 | Recruiting | Sponsor: Amgen | Trial completion date: Oct 2023 ➔ Jul 2024 | Trial primary completion date: May 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Rozibafusp alfa: Completion of P2 trial (NCT04058028) for SLE in H2 2023 (Amgen) - Inflammation Portfolio from EADV

Trial completion date • Lupus

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "Otezla sales decreased 1% year-over-year for the first quarter, driven by declines in net selling price and inventory, substantially offset by volume growth. In the U.S., TRx volumes grew 11% year-over-year...Tezepelumab: A Phase 2 study continues to enroll patients with chronic obstructive pulmonary disease....A Phase 3 chronic rhinosinusitis with nasal polyps study has initiated....Rozibafusp alfa (AMG 570)...continues to enroll patients with systemic lupus erythematosus (SLE) in a Phase 2b study....A Phase 2b study of efavaleukin alfa (AMG 592)…has been initiated, and enrollment of patients with SLE is expected to begin in Q2 2021. Data from the Phase 1b SLE study will be submitted to a medical conference in H2 2021."

Enrollment status • P1 data • Sales • Trial status • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Lupus • Respiratory Diseases • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b; N=320; Recruiting; Sponsor: Amgen; Trial completion date: Mar 2024 ➔ Oct 2023

Clinical • Trial completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b; N=320; Recruiting; Sponsor: Amgen; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2b; N=320; Active, not recruiting; Sponsor: Amgen; Recruiting ➔ Active, not recruiting; Phase classification: P2 ➔ P2b; Trial completion date: Sep 2023 ➔ Mar 2024; Trial primary completion date: Nov 2022 ➔ May 2023

Clinical • Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] Safety and Biological Activity of Rozibafusp Alfa in Subjects with Rheumatoid Arthritis: Final Results of a Phase 1b Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study (ACR-ARHP 2020) - P1 | "Multiple ascending doses of rozibafusp alfa were safe and generally well tolerated, with exploratory efficacy results observed in the highest dose cohorts. PK/PD analysis demonstrated nonlinear, target-mediated disposition consistent with cell surface target interaction and PD activity consistent with dual ICOSL/BAFF neutralization. These findings informed the design and dose selection of an ongoing phase 2, randomized, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active SLE and inadequate responses to standard of care therapy."

Clinical • P1 data • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Amgen; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=34; Completed; Sponsor: Amgen; Active, not recruiting ➔ Completed; Trial completion date: Oct 2020 ➔ Jun 2020

Clinical • Trial completion • Trial completion date • Immunology • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND PRELIMINARY EFFICACY OF ROZIBAFUSP ALFA IN SUBJECTS WITH RHEUMATOID ARTHRITIS: INTERIM ANALYSIS OF A PHASE 1B RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE CLINICAL TRIAL (EULAR 2020) - P1 | "All subjects were maintained on a stable dose of methotrexate. This interim analysis is the first to report the safety and tolerability of multiple ascending doses of rozibafusp alfa in RA subjects, with preliminary efficacy findings observed in the highest dose cohorts. PK/PD analysis demonstrated nonlinear, target-mediated disposition consistent with cell surface target interaction and PD activity consistent with dual ICOSL/BAFF neutralization. These findings informed the design and dose selection of an ongoing phase 2, randomized, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active SLE and inadequate responses to standard of care therapy."

Clinical • P1 data • PK/PD data • Immunology • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2; N=300; Active, not recruiting; Sponsor: Amgen; Recruiting ➔ Active, not recruiting; Trial completion date: May 2023 ➔ Sep 2023; Trial primary completion date: Jul 2022 ➔ Nov 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Lupus • Systemic Lupus Erythematosus

Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: Amgen; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Lupus • Systemic Lupus Erythematosus

AMG 570: Data from P1a trial (NCT02618967) in healthy volunteers in Q4 2018 (AstraZeneca) - Q3 2018 Results

P1 data • Lupus

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Amgen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Amgen; Trial completion date: Aug 2023 ➔ Mar 2023; Trial primary completion date: Oct 2022 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Amgen; Trial completion date: Mar 2023 ➔ Aug 2023; Initiation date: Dec 2019 ➔ Mar 2020; Trial primary completion date: Apr 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

Development of an ICOSL and BAFF bispecific inhibitor AMG 570 for systemic lupus erythematosus treatment. (PubMed, Clin Exp Rheumatol) - "By targeting both ICOSL and BAFF, AMG 570 has the potential to achieve superior efficacy in treatment of autoimmune diseases such as SLE and rheumatoid arthritis."

Journal

Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=34; Active, not recruiting; Sponsor: Amgen; Trial completion date: Oct 2019 ➔ Oct 2020

Clinical • Trial completion date