ACTIVE_NOT_RECRUITING

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

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Conditions

Severe AsthmaVALIANTRespiratory Tract DiseasesBronchial DiseasesAsthmaLung DiseasesUncontrolled Asthma

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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

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

Quick Facts

Study Start:2024-02-27
Study Completion:2026-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06196879

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
  2. * Age 18 to 80 years of age (inclusive) at the time of consent.
  3. * Physician-diagnosed asthma for at least 12 months prior to Visit 1.
  4. * Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
  5. * Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.
  6. * Documented history of asthma exacerbation(s) within 12 months of Visit 1.
  7. * Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (\>=) 1.5 at screening and randomization.
  8. * Participant must have a pre-BD FEV1 value of \>=30 percent (%) and \<=80% predicted at Screening.
  9. * Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
  10. * Agrees to follow the required contraceptive techniques/methods.
  11. * Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.
  1. * Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
  2. * Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
  3. * Previous biologics, including those for asthma treatment, for which the appropriate washout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied.
  4. * Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study.
  5. * For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is \>10 milligram (mg) daily, or \>20 mg every other day.
  6. * Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1.
  7. * History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
  8. * Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history \>=10 pack years. (Former nicotine smokers with a smoking history of \<10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible).
  9. * Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1.
  10. * Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.

Contacts and Locations

Principal Investigator

James C Lee, MD
STUDY_DIRECTOR
Upstream Bio

Study Locations (Sites)

AllerVie Clinical Research
Birmingham, Alabama, 35209
United States
Kern Research, Inc.
Bakersfield, California, 93301
United States
Velocity Clinical Research - Lafayette LA
Los Angeles, California, 70508
United States
Newport Native MD Inc
Newport Beach, California, 92663
United States
California Medical Research Associates Inc.
Northridge, California, 91324
United States
Integrated Research of Inland Inc
Upland, California, 91786
United States
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
United States
Allianz Research Institute
Westminster, California, 92683
United States
Woodland Clinic Medical Group
Woodland, California, 95695
United States
National Jewish Health
Denver, Colorado, 80206
United States
Advance Pharma Research
Cutler Bay, Florida, 33189
United States
Unique Clinical Trials
Doral, Florida, 33172
United States
Health and Life Research Institute, LLC
Miami, Florida, 33155
United States
Phoenix Medical Research
Miami, Florida, 33165
United States
Research Institute of South Florida
Miami, Florida, 33173
United States
Nouvelle Clinical Research
Miami, Florida, 33189
United States
Anderson Allergy And Asthma, PA
Orlando, Florida, 32806
United States
Edward Jenner Research Group, LLC
Plantation, Florida, 33317
United States
R&B Medical Center
Tampa, Florida, 33614
United States
Clinical Site Partners dba Flourish research
Winter Park, Florida, 32789
United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038
United States
RNA America Health Sciences
Sugar hill, Georgia, 30518
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
Velocity Clinical Research - Meridian
Meridian, Idaho, 83642
United States
Howard County Center for Lung and Sleep Medicine LLC
Columbia, Maryland, 21044
United States
Chesapeake Clinical Research Inc
White Marsh, Maryland, 21162
United States
Exordia Medical Research Inc
Fall River, Massachusetts, 02723
United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336
United States
AA Medical Research Center
Flint, Michigan, 48504
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
M3 Wake Research
Las Vegas, Nevada, 89106
United States
Urban Health Plan INC
Bronx, New York, 10459
United States
Advanced Respiratory and Sleep Medicine LLC
Huntersville, North Carolina, 28078
United States
Summit Research Group LLC
Munroe Falls, Ohio, 44262
United States
Toledo Institute of Clinical Research Inc
Toledo, Ohio, 43617
United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
United States
Portland Clinical Research
Clackamas, Oregon, 97015
United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504
United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
United States
WR-Notus Clinical Research, LLC
Charleston, South Carolina, 29414
United States
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
United States
Horizon Clinical Research
Cypress, Texas, 77429
United States
Alina Clinical Trials, LLC
Dallas, Texas, 75225
United States
AARA Research Center
Dallas, Texas, 75231
United States
El Paso Pulmonary Association
El Paso, Texas, 79902
United States
Greater Houston Memorial Pulmonary and Sleep
Houston, Texas, 77008
United States
Sante Clinical Research
Kerrville, Texas, 78028
United States
Mayflower Clinical
Marble Falls, Texas, 02747
United States
Metroplex Pulmonary and Sleep Center Drive
McKinney, Texas, 75069
United States
Element Research Group
San Antonio, Texas, 78258
United States
DM Clinical Tomball
Tomball, Texas, 77375
United States
Velocity Clinical Research
West Jordan, Utah, 84088
United States
University of Wisconsin--Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Upstream Bio Inc.

  • James C Lee, MD, STUDY_DIRECTOR, Upstream 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 Date2024-02-27
Study Completion Date2026-06-11

Study Record Updates

Study Start Date2024-02-27
Study Completion Date2026-06-11

Terms related to this study

Keywords Provided by Researchers

  • VALIANT
  • Respiratory Tract Diseases
  • Bronchial Diseases
  • Asthma
  • Lung Diseases
  • Uncontrolled Asthma
  • Severe Asthma

Additional Relevant MeSH Terms

  • Severe Asthma