efavaleukin alfa (AMG 592) / Amgen - LARVOL DELTA

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=224 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Efavaleukin alfa (AMG 592)...A Phase 2b study of efavaleukin alfa in patients with ulcerative colitis was terminated due to the study meeting a prespecified futility threshold, and not related to safety concerns."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=224 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Oct 2024 | Trial primary completion date: Feb 2025 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=92 ➔ 25 | Trial completion date: Jan 2028 ➔ Oct 2024 | Trial primary completion date: Jan 2028 ➔ Oct 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Efavaleukin alfa (AMG 592); Efavaleukin alfa is an interleukin 2 (IL 2) mutein Fc fusion protein. A Phase 2b study of efavaleukin alfa continues to enroll patients with ulcerative colitis."

Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: Amgen | N=140 ➔ 92

Enrollment change • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=168 | Terminated | Sponsor: Amgen | Phase classification: P2b ➔ P2

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

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Amgen | Trial completion date: May 2028 ➔ Jan 2028 | Trial primary completion date: May 2028 ➔ Jan 2028

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Amgen | Trial completion date: May 2026 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Feb 2025

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

TARGETING IMPROVED TREG SELECTIVITY WITH THE IL-2 MUTEIN EFAVALEUKIN ALFA: RATIONALE FOR IL-2 THERAPY IN ULCERATIVE COLITIS (DDW 2024) - P1b, P2 | "Low-dose recombinant IL- (aldesleukin) has shown disease-modifying activity in UC in early clinical studies but has a small selectivity window for Treg over conventional CD4+ T cells (Tcon) and natural killer (NK) cells with the potential for inflammatory cell expansion and adverse events (AE) related to low selectivity. Preclinical and phase 1 results with efavaleukin alfa showed highly selective expansion of Treg with minimal effects on pro-inflammatory immune cells. These findings support the rationale and design of an ongoing phase b study investigating the safety and efficacy of efavaleukin alfa induction therapy in patients with moderate to severe active UC (NCT04987307)."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Ulcerative Colitis • CD4 • CD8 • CRP • FOXP3 • IL6 • STAT5

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2025 ➔ May 2026 | Trial primary completion date: Jun 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2027 ➔ May 2028 | Trial primary completion date: Apr 2027 ➔ May 2028

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease (clinicaltrials.gov) - P1/2 | N=32 | Terminated | Sponsor: Amgen | Phase classification: P1b/2 ➔ P1/2 | Completed ➔ Terminated; Sponsor Decision

Phase classification • Trial termination • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS (PRNewswire) - "Efavaleukin alfa (AMG 592): A Phase 2b study of efavaleukin alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, in ulcerative colitis continues to enroll patients."

Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Amgen | N=200 ➔ 140

Enrollment change • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

TARGETING IMPROVED TREG SELECTIVITY WITH THE IL-2 MUTEIN EFAVALEUKIN ALFA: RATIONALE FOR IL-2 THERAPY IN ULCERATIVE COLITIS (UEGW 2023) - P1b, P2 | "Efavaleukin alfa is a novel IL-2 therapy that has an increased therapeutic window compared with aldesleukin. Preclinical and phase 1 results with efavaleukin alfa demonstrated highly selective expansion of Treg with minimal effects on pro-inflammatory immune cells. These findings support the rationale and design of an ongoing phase 2b study investigating the safety and efficacy of efavaleukin alfa induction therapy in patients with moderate to severe active UC (NCT04987307)."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Systemic Lupus Erythematosus • Ulcerative Colitis • CD4 • CD8 • CRP • FOXP3 • IL6 • STAT5

AMGEN REPORTS SECOND QUARTER FINANCIAL RESULTS (PRNewswire) - "Efavaleukin alfa (AMG 592): A Phase 2b study of efavaleukin alfa in ulcerative colitis continues to enroll patients."

Enrollment status • Graft versus Host Disease • Immunology • Inflammatory Bowel Disease • Systemic Lupus Erythematosus • Ulcerative Colitis

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 Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2b | N=168 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.

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

Regulatory T Cell Defects in SLE and Therapy With a Novel IL-2 Mutein: Phase 1 Clinical Results With Efavaleukin Alfa (EULAR 2023) - P1b | "CD25 bright Treg, considered a more suppressive Treg population, were expanded with multiple doses of efavaleukin alfa. Although low baseline SLE disease activity and short treatment duration precluded efficacy analysis, clinical correlations with treatment response will be investigated in the ongoing phase 2b adaptive trial of efavaleukin alfa in SLE."

Clinical • P1 data • Inflammatory Arthritis • CD4 • FOXP3 • IL2 • IL2RA • IL7R

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Amgen

New P1 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Amgen

New P1 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2026 ➔ Apr 2027 | Trial primary completion date: Sep 2026 ➔ Apr 2027

Enrollment open • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2b | N=168 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=320 ➔ 168 | Trial completion date: Jan 2025 ➔ May 2023 | Trial primary completion date: Dec 2024 ➔ May 2023

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