MHS552 / Novartis - LARVOL DELTA

IL-2 mutein-engrafted antibody MHS552 selectively expands functional regulatory T cells in nonclinical models and healthy participants. (PubMed, Nat Commun) - "Exploratory analyses confirm selective Treg activation, with expanded Treg retaining their suppressive function ex vivo. These findings support IL-2-based therapeutics for autoimmune disorders, while the SAE highlights the need for careful safety evaluation."

Clinical • First-in-human • Journal • Immunology • IL2

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2024 ➔ Jun 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2024 ➔ Jun 2023; Sponsor Decision

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

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=28 ➔ 8

Enrollment change • Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Novartis Pharmaceuticals | N=28 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: May 2024 ➔ Aug 2024

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

Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2024 ➔ Apr 2025 | Initiation date: Oct 2022 ➔ Feb 2023 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2024 ➔ Dec 2024 | Initiation date: Jul 2022 ➔ Oct 2022 | Trial primary completion date: May 2024 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2024 ➔ Sep 2024

Trial completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

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

Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus