IBI-3002 / Innovent Biologics - LARVOL DELTA

First-in-class anti-IL-4Rα/TSLP bispecific antibody IBI3002 in asthma: a randomized, double-blind, placebo-controlled phase I study (ERS 2026) - "IBI3002 was well tolerated and demonstrated a favorable safety profile, with substantial and sustained improvements in lung function and anti-inflammatory effects. Follow-up is ongoing and results will be updated at the meeting."

Bispecific • Clinical • P1 data • Asthma • Immunology • Inflammation • Respiratory Diseases • TSLP

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

IBI3002, A First-in-class Anti-IL-4RΑ/TSLP Bispecific Antibody in Patients With Mild-To-Moderate Asthma: A Randomized, Double-Blind, Placebo-Controlled, Single Dose Phase Ib Study (ATS 2026) - No abstract available

Clinical • P1 data • Asthma • Immunology • Respiratory Diseases • TSLP

A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=96 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Sep 2025 | Trial primary completion date: Feb 2025 ➔ Jul 2025

First-in-human • Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Preclinical Characterization of IBI3002, an Anti-IL-4Rα and Anti-TSLP Bispecific Antibody That Potently Dampens Inflammatory Response and Alleviates Asthma in Mice (ATS 2025) - "an innovative IL4RxTSLP bispecific antibody is characterized for its potent and synergistic inhibition of both IL4, IL13 and the upstream epithelial trigger TSLP. This molecule suppresses airway inflammation more potently than Dupixent, Tezepelumab and Lunsekimig even at lower concentration in-vitro or with lower exposure in-vivo. Therefore, IBI3002 can potentially bring broader and deeper clinical benefits to asthma patients of both high and med/low eosinophil counts."

Preclinical • Asthma • Immunology • Inflammation • Respiratory Diseases • CRLF2 • IL13 • IL4 • IL4R • TSLP

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Innovent Announces First Participant Dosed in a Phase I Study of IBI3002 (an anti-IL-4Rα/TSLP bispecific antibody) in Australia (PRNewswire) - "Innovent Biologics...announces that the first participant has been dosed in Australia in a first-in-human (FIH) phase 1 clinical trial of IBI3002, a global first-in-class bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). This FIH study (NCT06213844) is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) (only in participants with asthma) of IBI3002 in healthy participants and participants with mild to moderate asthma, and to support further global clinical development of IBI3002."

Trial status • Asthma

A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases