LY3541860 / Eli Lilly - LARVOL DELTA

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=63 | Terminated | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Terminated; The interim analysis data failed to demonstrate the intended treatment effect.

Trial termination • CNS Disorders • Multiple Sclerosis

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=35 | Terminated | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Terminated; The interim analysis data failed to demonstrate the intended treatment effect.

Trial termination • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Sep 2026 ➔ May 2026

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

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=63 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting | N=200 ➔ 63 | Trial completion date: Aug 2028 ➔ Jul 2026 | Trial primary completion date: Aug 2027 ➔ Nov 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Next on the chopping block is LY3541860, an anti-CD19 antibody tested out in mid-stage studies for both multiple sclerosis (MS) and rheumatoid arthritis (RA). (FierceBiotech) - "In the RA trial, the autoimmune asset was being evaluated for its ability to impact disease activity compared to baseline among 35 patients...'The termination was not safety-driven'...'The asset did not meet Lilly’s high bar for continued development.'...Meanwhile, the MS phase 2a/2b trial for LY3541860 is slated to readout in August of 2027."

Discontinued • P2 data • Trial status • Multiple Sclerosis • Rheumatoid Arthritis

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

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

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Eli Lilly and Company

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

The Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of a Non-B Cell-Depleting CD19 IgG4 Monoclonal Antibody, LY3541860: Results from a Single- and Multiple-Ascending Dose Study in Healthy Participants (ECTRIMS 2024) - "These results demonstrate that LY3541860 is a non-depleting B cell targeting monoclonal antibody with a low incidence of AEs. Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development. Meric Ovacik and Kedan Lin."

Clinical • PK/PD data • Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • CD22

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Aug 2028 | Trial primary completion date: Apr 2025 ➔ Aug 2027

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=94 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Aug 2028 ➔ Mar 2026 | Trial primary completion date: Aug 2027 ➔ Apr 2025

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Mar 2026 ➔ Aug 2028 | Trial primary completion date: Apr 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • CNS Disorders • Multiple Sclerosis

A nondepleting anti-CD19 antibody impairs B cell function and inhibits autoimmune diseases. (PubMed, JCI Insight) - "Here we describe a nondepleting, high-affinity anti-human CD19 antibody LY3541860 that exhibits potent B cell inhibitory activities...Similarly, our potent anti-mCD19 antibody also demonstrates improved efficacy over CD20 B cell depletion therapy in multiple B cell-dependent autoimmune disease models. Our data indicate that anti-CD19 antibody is a highly potent B cell inhibitor that may have potential to demonstrate improved efficacy over currently available B cell-targeting therapies in treatment of autoimmune conditions without causing B cell depletion."

Journal • Immunology • CD20

A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jul 2023 ➔ Jun 2024 | Trial primary completion date: Jul 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date

A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Nov 2022 ➔ Jun 2023 | Trial primary completion date: Nov 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date