ALM223 / Almirall, Simcere - LARVOL DELTA

Simcere Pharmaceutical Group…announced that its regulatory T cells（Treg）-preferential IL-2 mutant Fc fusion protein (IL-2 mu-Fc), SIM0278, has officially entered a Phase II clinical study in China for the treatment of moderate-to-severe atopic dermatitis (AD) (PRNewswire) - "The first dose was achieved in Hangzhou First People's Hospital. This randomized, double-blind, placebo-controlled, multi-center Phase II study is aiming to evaluate the efficacy, safety, and pharmacokinetics of continuous subcutaneous administration of SIM0278 in participants with moderate-to-severe AD."

Trial status • Atopic Dermatitis

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=184 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Sep 2024 ➔ May 2025

Trial completion date • Trial primary completion date • CD4 • CD8

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial