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

ClinicalTrials.gov ID: NCT07120503

Public ClinicalTrials.gov record NCT07120503. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 2:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a global Phase 2 study divided in two parts. Part A is a double-blind, randomized dose-range finding study in adults with moderate to severe asthma to confirm the dosing regimen of WIN378 that can be tested in future pivotal trials for efficacy and safety. Part B is a pivotal double-blind, randomized study to demonstrate the efficacy and safety of WIN378 in adults with severe uncontrolled asthma. Two dose levels of WIN378 will be tested against placebo to evaluate AAER, lung function, asthma control, asthma-related quality of life and other important efficacy endpoints.

Study identification

NCT ID: NCT07120503
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Windward Bio; Industry
Enrollment: 600 participants

Conditions and interventions

Conditions

Asthma

Interventions

WIN378 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 24, 2025 (Actual)
Primary completion: Oct 1, 2028 (Estimated)
Completion: Nov 23, 2028 (Estimated)
Last update posted: Oct 21, 2026

2025 – 2028

United States locations

U.S. sites: 21
U.S. states: 14
U.S. cities: 21

Facility	City	State	ZIP	Site status
WB Contracted Clinical Research Site	Los Angeles	California	90025-7014	Active, not recruiting
WB Contracted Clinical Research Site	San Jose	California	95117	Active, not recruiting
WB Contracted Clinical Research Site	Melbourne	Florida	32763	Recruiting
WB Contracted Clinical Research Site	Miami	Florida	33175	Active, not recruiting
WB Contracted Clinical Research Site	White Marsh	Maryland	21162	Active, not recruiting
WB Contracted Clinical Research Site	Stow	Massachusetts	01775-1205	Active, not recruiting
WB Contracted Clinical Research Site	Detroit	Michigan	48202-2608	Active, not recruiting
WB Contracted Clinical Research Site	Richfield	Minnesota	55423-2477	Active, not recruiting
WB Contracted Clinical Research Site	St Louis	Missouri	98119	Active, not recruiting
WB Contracted Clinical Research Site	Bellevue	Nebraska	68123	Active, not recruiting
WB Contracted Clinical Research Site	Toledo	Ohio	43560	Recruiting
WB Contracted Clinical Research Site	Edmond	Oklahoma	73034	Active, not recruiting
WB Contracted Clinical Research Site	Pittsburgh	Pennsylvania	15213-3236	Active, not recruiting
WB Contracted Clinical Research Site	Charleston	South Carolina	29420	Active, not recruiting
WB Contracted Clinical Research Site	Spartanburg	South Carolina	29303	Active, not recruiting
WB Contracted Clinical Research Site	Austin	Texas	78730	Active, not recruiting
WB Contracted Clinical Research Site	El Paso	Texas	79903	Active, not recruiting
WB Contracted Clinical Research Site	McKinney	Texas	75069-8085	Recruiting
WB Contracted Clinical Research Site	San Antonio	Texas	78229	Active, not recruiting
WB Contracted Clinical Research Site	Tyler	Texas	75708-3154	Active, not recruiting
WB Contracted Clinical Research Site	Richmond	Virginia	23226	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07120503, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 21, 2026 · Synced Oct 23, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT07120503 live on ClinicalTrials.gov.

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