donzakimig (UCB1381) / UCB - LARVOL DELTA

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) (clinicaltrials.gov) - P1/2 | N=273 | Active, not recruiting | Sponsor: UCB Biopharma SRL | N=152 ➔ 273 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting

Enrollment closed

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 Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: Apr 2025 ➔ Oct 2025 | Trial primary completion date: Apr 2025 ➔ Jul 2025

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

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: UCB Biopharma SRL

New P1 trial

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: Nov 2024 ➔ Feb 2025 | Trial primary completion date: Nov 2024 ➔ Feb 2025

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

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) (clinicaltrials.gov) - P1/2 | N=152 | Not yet recruiting | Sponsor: UCB Biopharma SRL

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology