RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2025-07-24
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07120503

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written Informed Consent Form
  2. * 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
  3. * Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
  4. * Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening
  5. * Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
  1. * Participants with a known, pre-existing, clinically important lung condition other than asthma
  2. * Active tuberculosis or treatment required for tuberculosis within 12 months
  3. * Current or former smokers ≥10 pack years
  4. * History of cancer
  5. * 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
  6. * Helminth infection in prior 24 months
  7. * Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period
  8. * Participants who are pregnant, lactating or breastfeeding

Contacts and Locations

Study Contact

Daniela Kopecka
CONTACT
+41 61 551 71 39
clinical.trial.enquiry@windwardbio.com

Principal Investigator

Omar Khwaja, MD
STUDY_DIRECTOR
Windward Bio

Study Locations (Sites)

WB Contracted Clinical Research Site
Los Angeles, California, 90025-7014
United States
WB Contracted Clinical Research Site
San Jose, California, 95117
United States
WB Contracted Clinical Research Site
Miami, Florida, 33175
United States
WB Contracted Clinical Research Site
Spartanburg, South Carolina, 29303
United States
WB Contracted Clinical Research Site
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Windward Bio

  • Omar Khwaja, MD, STUDY_DIRECTOR, Windward Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-24
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-07-24
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Moderate Asthma
  • Severe Asthma
  • Uncontrolled Asthma
  • Respiratory Diseases
  • Lung Diseases
  • Bronchial Diseases
  • Allergic Diseases

Additional Relevant MeSH Terms

  • Asthma (Diagnosis)