galvokimig (UCB9741) / UCB - LARVOL DELTA

A first-in-patient 18-week study of galvokimig, a multispecific antibody–based therapeutic targeting interleukin (IL)-13, IL-17A, and IL-17F in participants with moderate-to-severe atopic dermatitis (AD) (EADV 2025) - P1/2 | "This first-in-patient study met its primary endpoints, with galvokimig demonstrating a clinically meaningful and rapid improvement in efficacy measures, and safety outcomes associated with an acceptable benefit–risk profile. Phase 2/3 studies will further determine the benefit–risk profile of galvokimig administered subcutaneously in participants with AD."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • IL13 • IL17A

UCB announces successful first-in-patient trial for galvokimig in moderate-to-severe atopic dermatitis at EADV (UCB Press Release) - "In the Phase 2a trial, patients (n=47) received galvokimig (n=33) or placebo (n=14). At Week 12, a median of 64.9% of patients achieved EASI75 with galvokimig versus 12.3% with placebo. Also at Week 12, a median of 46.6% of patients achieved EASI90 with galvokimig versus 3.5% with placebo....After 18 weeks, the most common treatment-emergent adverse events (TEAEs) with galvokimig were rhinitis, nasopharyngitis, headache, dizziness and oropharyngeal pain."

P2a data • Atopic Dermatitis

Galvokimig, a multispecific antibody-based therapeutic, for the treatment of inflammatory skin diseases associated with both type 2 and type 3 inflammation (ESDR 2025) - "Funding: UCB. Medical writing and editorial assistance: HCG."

Atopic Dermatitis • Dermatitis • Dermatology • Inflammation • IL13 • IL17A • IL4 • IL6

On Growth Path for a Decade plus: Strong Launch Execution driving Company Growth (PRNewswire) - "UCB9741/ galvokimig...The phase 2a study in moderate-to-severe atopic dermatitis - a type of eczema, which is the most common inflammatory skin disease - showed positive and convincing proof-of-concept data – to be presented at an upcoming scientific meeting in 2025...UCB1381/ donzakimig...Recruitment for the Phase 2a study in atopic dermatitis (AtD) is progressing slower than anticipated, leading to an updated timeline with results now expected in the second half of 2025...The phase 3 study to evaluate the efficacy and safety of bimekizumab in Chinese study participants with moderate to severe plaque psoriasis (PSO) reported positive results...Submission to the Chinese regulatory authorities is planned for H2 2025."

China filing • P2a data • Atopic Dermatitis • Psoriasis

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=107 | Completed | Sponsor: UCB Biopharma SRL | Phase classification: P1 ➔ P1/2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2025 ➔ Oct 2024 | Trial primary completion date: Jul 2025 ➔ Oct 2024

Enrollment open • Trial completion date • Trial primary completion date

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=107 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: UCB Biopharma SRL | Initiation date: Mar 2024 ➔ Jul 2024

Trial initiation date

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: UCB Biopharma SRL

New P1 trial

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: UCB Biopharma SRL | Phase classification: P1/2 ➔ P1

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: Aug 2023 ➔ Nov 2024 | Trial primary completion date: Aug 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=159; Recruiting; Sponsor: UCB Biopharma SRL; Trial completion date: Nov 2022 ➔ Aug 2023; Trial primary completion date: Nov 2022 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology