Phase 2 Randomized Study of WIN378 in Adults with Mod/Severe Asthma
Research type
Research Study
Full title
A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants with Moderate or Severe Asthma
IRAS ID
1012393
Contact name
Mahir Karababa
Contact email
Sponsor organisation
Windward Bio AG
Research summary
WB-2101 is a Phase 2 study being conducted to evaluate the safety and efficacy, and to describe the pharmacokinetics (PK) and immunogenicity of WIN378 in Adult Participants with Moderate or Severe Asthma. The study uses a specific design called doubleblind, randomised, placebo-controlled.
The main goals of this study are to see how safe and well-tolerated WIN378 is, understand how the body processes the drug (this is called pharmacokinetics), check how the immune system responds to it (immunogenicity), and gather information on how effective it may be in treating asthma.
This study drug (WIN378) is an antibody that blocks the immune molecule, thymic stromal lymphopoietin (TSLP), in the body. Due to the higher levels of TSLP in people with asthma compared to people without asthma, WIN378 is a laboratory-made antibody that attaches to TSLP, which may improve lung function and reduce asthma symptoms in people with asthma. There are 4 periods: the Screening period (weeks–8 to –4); the run-in period (weeks -4 to 0); the treatment period (weeks 0 to 48) and, the follow-up period (weeks 48 to 60).
The study will take place at around 100 sites in several countries. Around 136 adults aged 18 to 75 will take part in this study. Participants will be randomly assigned to one of four groups. Some will receive one of three different doses of WIN378, and others will receive a placebo (a substance with no active medicine). Each participant will receive two injections of either WIN378 or placebo: The first dose will be given at the start of the study (Week 0, Day 1), the second dose will be given 24 weeks later (Week 24). They will receive an injection into the skin of the abdomen or the skin of the top of the thigh.REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0147
Date of REC Opinion
21 Aug 2025
REC opinion
Further Information Unfavourable Opinion