ravagalimab (ABBV-323) / AbbVie - LARVOL DELTA

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

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

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: AbbVie

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

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: AbbVie

New P1 trial

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=42; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed; Trial completion date: May 2023 ➔ Jan 2022; Trial primary completion date: Dec 2021 ➔ Apr 2021

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

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=42; Active, not recruiting; Sponsor: AbbVie; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ravagalimab: Proof-of-concept data from P2 trial (NCT03695185) in patients with moderate-to-severe ulcerative colitis in 2021 (AbbVie, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P2 data • Inflammatory Bowel Disease • Ulcerative Colitis

Ravagalimab: Proof-of-concept data from P2 trial (NCT03695185) in patients with moderate-to-severe ulcerative colitis in 2021 (AbbVie, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P2 data • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: AbbVie; Trial completion date: Aug 2022 ➔ Mar 2023; Trial primary completion date: Dec 2020 ➔ Dec 2021

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

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: AbbVie; N=30 ➔ 40; Trial completion date: Nov 2021 ➔ Aug 2022

Clinical • Enrollment change • Trial completion date • Gastroenterology • Inflammatory Bowel Disease • Ulcerative Colitis

AbbVie Inc Q4 2019 earnings call transcript (The Motley Fool) - "We will also see proof of concept data this year from several other early stage assets in our immunology portfolio, including data for ABBV-599, our JAK/BTK program, and ABBV-323, our CD40 antagonist program, which are both targeting multiple pathogenic nodes that are thought to play important roles in diseases such as RA, IBD, lupus and scleroderma, allowing us to restate standard."

Clinical data

Ravagalimab: Initiation of P3 trial for ulcerative colitis in 2021 (AbbVie) - Pipeline Update: Proof-of-concept data from P2 trial (NCT03695185) for ulcerative colitis in 2020

New P3 trial • P2 data

CD40/anti-CD40 antibody complexes which illustrate agonist and antagonist structural switches. (PubMed, BMC Mol Cell Biol) - "The structure of ABBV-323 Fab demonstrates a unique method for antagonism by stabilizing the proposed functional antiparallel dimer for CD40 receptor via novel contacts to LCDR1, namely residue position R32 which is further supported by a closely related agonist antibody FAB516 which shows only monomeric recognition and no contacts with LCDR1 due to a mutation to L32 on LCDR1. These data provide a structural basis for the full antagonist activity of ABBV-323."

IO Biomarker • Journal

A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: AbbVie; N=60 ➔ 30; Trial completion date: May 2022 ➔ Nov 2021

Clinical • Enrollment change • Trial completion date

TRANSLATIONAL STUDIES IN NONHUMAN PRIMATES AND HUMAN VOLUNTEERS SUPPORT THE PHASE 2 PROGRAM FOR RAVAGALIMAB IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UEGW 2019) - P2; "Translational evidence from an animal model and human cell assays strongly supports testing of the anti-CD40 antagonist mAb ravagalimab in a phase 2a study in patients with UC."

P2 data

TRANSLATIONAL STUDIES IN NONHUMAN PRIMATES AND HUMAN VOLUNTEERS SUPPORT THE PHASE 2 PROGRAM FOR RAVAGALIMAB IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UEGW 2019) - P2; "Translational evidence from an animal model and human cell assays strongly supports testing of the anti-CD40 antagonist mAb ravagalimab in a phase 2a study in patients with UC."

P2 data

A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: AbbVie; N=40 ➔ 60

Clinical • Enrollment change

A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: AbbVie; N=68 ➔ 40

Clinical • Enrollment change

A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - P2; N=68; Recruiting; Sponsor: AbbVie; Not yet recruiting ➔ Recruiting; Trial completion date: Oct 2023 ➔ Mar 2022; Initiation date: Oct 2018 ➔ Mar 2019

Clinical • Enrollment open • Trial completion date • Trial initiation date