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

Description

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)
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Related Conditions:

Asthma (Diagnosis)

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Asthma (Diagnosis)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

WB Contracted Clinical Research Site, Los Angeles, California, United States, 90025-7014

San Jose

WB Contracted Clinical Research Site, San Jose, California, United States, 95117

Miami

WB Contracted Clinical Research Site, Miami, Florida, United States, 33175

Spartanburg

WB Contracted Clinical Research Site, Spartanburg, South Carolina, United States, 29303

Richmond

WB Contracted Clinical Research Site, Richmond, Virginia, United States, 23226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written Informed Consent Form
  • * Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method
  • * Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
  • * Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening
  • * Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
  • * Participants with a known, pre-existing, clinically important lung condition other than asthma
  • * Active tuberculosis or treatment required for tuberculosis within 12 months
  • * Current or former smokers ≥10 pack years
  • * History of cancer
  • * Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to screening; receipt of immunoglobulin or blood products within 30 days prior to screening or during the Screening Run-in period; receipt of any live or attenuated vaccines within 15 days prior to screening
  • * Helminth infection in prior 24 months
  • * Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period
  • * Participants who are pregnant, lactating or breastfeeding

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Windward Bio,

Omar Khwaja, MD, STUDY_DIRECTOR, Windward Bio

Study Record Dates

2027-10