trosunilimab (ABBV-382) / AbbVie - LARVOL DELTA

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis (clinicaltrials.gov) - P2 | N=2000 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease or Ulcerative Colitis (clinicaltrials.gov) - P2 | N=2000 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A study evaluating adverse events and drug movement in healthy adult volunteers in China following subcutaneous (SC) and intravenous (IV) administration of ABBV-382. (clinicaltrials.gov) - P1 | N=0 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=163 | Terminated | Sponsor: AbbVie | Completed ➔ Terminated; Company Decision

Adverse events • Trial termination • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=163 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | Trial completion date: Mar 2027 ➔ Sep 2025 | Trial primary completion date: Mar 2027 ➔ Sep 2025

Adverse events • Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion

A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AbbVie

Adverse events • New P1 trial

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: AbbVie | Trial completion date: Oct 2026 ➔ Mar 2027 | Trial primary completion date: Apr 2025 ➔ Mar 2027

Adverse events • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2 | N=500 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2 | N=500 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: AbbVie | Trial completion date: Nov 2025 ➔ Oct 2026

Adverse events • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

ABBV-382, an Anti-α4β7 Ab That Enhances HIV-1 Antigen Presentation for Immune-Mediated Viral Control (CROI 2024) - "Our study results provide evidence of the antiviral and immunomodulatory properties of ABBV-382 through two main mechanisms: (1) Direct antagonism of the interaction of α4β7 with its ligand MAdCAM-1 or HIV-1 gp120, leading to inhibition of HIV-1 replication or cell-to cell viral spread, respectively, and (2) Enhanced viral antigen presentation to T cells enabled by the Fc-dependent uptake of ICs (HIV-1 virions and ABBV-382) by APCs. Taken together, ABBV-382 demonstrates favorable biological characteristics and novel mechanistic properties supporting its clinical evaluation as an immune-based intervention for HIV-1 viral control."

Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: AbbVie | Phase classification: P1b ➔ P1

Adverse events • Phase classification • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382 (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b | N=54 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b | N=54 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b | N=52 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Feb 2023 ➔ Jul 2023

Adverse events • Trial primary completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b | N=52 | Recruiting | Sponsor: AbbVie | Trial completion date: Feb 2023 ➔ Jun 2023

Adverse events • Trial completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b; N=52; Recruiting; Sponsor: AbbVie; Active, not recruiting ➔ Recruiting; Trial completion date: Sep 2022 ➔ Feb 2023; Trial primary completion date: Sep 2022 ➔ Feb 2023

Adverse events • Clinical • Enrollment open • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b; N=52; Active, not recruiting; Sponsor: AbbVie; Trial completion date: Oct 2021 ➔ Sep 2022; Trial primary completion date: Oct 2021 ➔ Sep 2022

Adverse events • Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b; N=2; Active, not recruiting; Sponsor: AbbVie; Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1) (clinicaltrials.gov) - P1b; N=52; Recruiting; Sponsor: AbbVie; Trial completion date: Feb 2022 ➔ Oct 2021

Trial completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4