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Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

NCT07120503 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-04-07

No results posted yet for this study

Summary

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).

Conditions

  • Asthma (Diagnosis)

Interventions

DRUG

WIN378

WIN378 is a fully human, long-acting monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over an extended dosing interval.

DRUG

Placebo

A sham injection consisting of placebo to mask WIN378.

Sponsors & Collaborators

  • Windward Bio

    lead INDUSTRY

Principal Investigators

  • Omar Khwaja, MD · Windward Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2027-07-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • France
  • Germany
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120503 on ClinicalTrials.gov