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

Severe Asthma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196879
• Other study ID #: UPB-CP-04
• Secondary ID: 2023-507410-27-0
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2024
• Est. completion date: June 11, 2026

Study information

• Verified date: April 2024
• Source: Upstream Bio Inc.
• Contact: Upstream Bio Clinical Trials Information (Privacy Notice: https:
• Phone: 888-446-3130
• Email: clinicaltrials[@]upstreambio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a multicenter, randomized, placebo-controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC). A total of approximately 436 adult participants with severe asthma are planned for enrolment and will be randomized in a 1:1:1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), and 100 mg every 24 weeks (Q24W), or placebo administered SC. In order to maintain the blinding of different doses, all participants will receive 2 SC injections at each dosing visit. This study consists of a Screening/Run-In Period (approximately 4 weeks), Treatment Period (up to 60 weeks with a minimum of 24 weeks) and Follow-up Period (ending approximately 16 weeks after the last administration of study intervention).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 436
• Est. completion date: June 11, 2026
• Est. primary completion date: February 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
• Age 18 to 75 years of age (inclusive) at the time of consent.
• Physician-diagnosed asthma for at least 12 months prior to Visit 1.
• Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
• 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.
• Documented history of asthma exacerbation(s) within 12 months of Visit 1.
• Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (>=) 1.5 at screening and randomization.
• Participant must have a pre-BD FEV1 value of >=30 percent (%) and <=80% predicted at Screening.
• Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
• Agrees to follow the required contraceptive techniques/methods.
• 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.

Exclusion Criteria:

• Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
• Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
• Previous biologics 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.
• Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study.
• 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.
• Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1.
• History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
• 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).
• Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1.
• 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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Drug:
• Verekitug (UPB-101)
Verekitug (UPB-101) formulated solution
• Placebo
Verekitug (UPB-101) matching placebo

Locations

Country	Name	City	State
Canada	Dynamic Drug Advancement	Ajax	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Toronto Allergists	Toronto	Ontario
Canada	Winchester Hospital	Winchester	Ontario
United States	Velocity Clinical Research - Anderson	Anderson	South Carolina
United States	Kern Research, Inc.	Bakersfield	California
United States	AllerVie Clinical Research	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Urban Health Plan INC	Bronx	New York
United States	WR-Notus Clinical Research, LLC	Charleston	South Carolina
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	AARA Research Center	Dallas	Texas
United States	Alina Clinical Trials, LLC	Dallas	Texas
United States	OK Clinical Research, LLC	Edmond	Oklahoma
United States	El Paso Pulmonary Association	El Paso	Texas
United States	Pulmonary Research Institute of Southeast Michigan	Farmington Hills	Michigan
United States	AA Medical Research Center	Flint	Michigan
United States	AA MRC	Flint	Michigan
United States	Greater Houston Memorial Pulmonary and Sleep	Houston	Texas
United States	Advanced Respiratory and Sleep Medicine LLC	Huntersville	North Carolina
United States	M3 Wake Research	Las Vegas	Nevada
United States	Velocity Clinical Research - Lafayette LA	Los Angeles	California
United States	Metroplex Pulmonary and Sleep Center Drive	McKinney	Texas
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Velocity Clinical Research - Meridian	Meridian	Idaho
United States	Clinical Site Partners	Miami	Florida
United States	Clinical Site Partners, LLC dba Flourish Research	Miami	Florida
United States	Health and Life Research Institute, LLC	Miami	Florida
United States	Nouvelle Clinical Research	Miami	Florida
United States	Phoenix Medical Research	Miami	Florida
United States	Research Institute of South Florida	Miami	Florida
United States	Newport Native MD Inc	Newport Beach	California
United States	California Medical Research Associates Inc.	Northridge	California
United States	Anderson Allergy And Asthma, PA	Orlando	Florida
United States	Edward Jenner Research Group, LLC	Plantation	Florida
United States	Velocity Clinical Research - Spartanburg	Spartanburg	South Carolina
United States	Toledo Institute of Clinical Research Inc	Toledo	Ohio
United States	DM Clinical Tomball	Tomball	Texas
United States	Integrated Research of Inland Inc	Upland	California
United States	Allergy & Asthma Clinical Research	Walnut Creek	California
United States	Velocity Clinical Research	West Jordan	Utah
United States	Allianz Research Institute	Westminster	California
United States	Chesapeake Clinical Research Inc	White Marsh	Maryland
United States	Clinical Site Partners dba Flourish research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Upstream Bio Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Asthma Exacerbation Rate (AAER)	An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.	Baseline up to Week 60
Secondary	Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60	Spirometry will be performed pre-bronchodilator (BD) to measure lung function. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.	Baseline to Week 60
Secondary	Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60	Standardized single breath FeNO test is performed to evaluate airway inflammation.	Baseline to Week 60
Secondary	Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60	ACQ-6 is a participant-reported questionnaire to assess asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.	Baseline to Week 60
Secondary	Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Up to Week 64