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NCT07610395PHASE2Recruiting

Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD

Altesa Biosciences, Inc.

Start Date

5/1/2026

Completion Date

11/15/2027

Summary

Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.

Eligibility Criteria

Age Range: 40 years to 85 years

Inclusion Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening. If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received. See Section 11.2 below. Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio \<0.70 and post bronchodilator FEV1 ≥20% and \<80% of predicted normal value). History of AECOPD with at least 1 documented AECOPD within 1 year of Screening. * AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for at least 2 days: * Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation) * Use of oral or systemic steroids (Moderate Exacerbation), or * Use of Antibiotics (Moderate Exacerbation), or * Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms. Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home. Inclusion criteria to be assessed only at Randomization: If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable). Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization. The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test. To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB. Exclusion Pregnant or nursing or expected to become pregnant during the study period. Experiencing a current/active or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months). Participants with other primary causes of chronic airflow limitation: \- Including but not limited to: asthma alone (COPD with asthmatic features is acceptable), CF, bronchiolitis obliterans, fibrosis such as TB, IPF, non-CF bronchiectasis with multi-lobe involvement or other major respiratory diagnosis (e.g., allergic bronchopulmonary aspergillosis), etc. Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled. Participants with hepatitis B are excluded. Participants on a stable treatment for HIV can be permitted with permission from the medical monitor. Participants with hepatitis C should be treated and confirmed HCV RNA negative prior to enrollment. (Testing performed at the Screening Visit). In the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease. Presence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF \> 450 msec (men) and a QTcF \> 460 msec (women). Medications or other non-medicinal products that could be impacted by CYP3A4, CYP2C8, or CYP2C19 induction and have serious complications for the participant within the treatment period. Medications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV. Medications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV. Medications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and/or life-threatening reactions. Use of either of the following treatments: * Chronic oral/systemic steroids \>10 mg per day (inhaled corticosteroids are permitted). * Continuous oxygen via nasal cannula of \>2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L/min thereafter). Participation in another investigational drug study within 5 half-lives prior to Screening and during the study is prohibited. This includes approved drugs being evaluated for a new indication. Observational studies are permitted. Participants who have taken VPV in another clinical trial. Exclusion criteria to be assessed only at Randomization: It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit. On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.

Interventions

DRUG

VPV 1000 mg

DRUG

VPV 500 mg

OTHER

Placebo

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Conditions

Rhinovirus Infection

Locations

Velocity Clinical Research - Mobile

Mobile, Alabama 36608

United States

AMR Clinical - Tempe

Tempe, Arizona 85281

United States

310 Clinical Research, LLC

Inglewood, California 90301

United States

NewportNativeMD, Inc.

Newport Beach, California 92663

United States

Apex Clinical Research

San Diego, California 92120

United States

Synergy Health

Bradenton, Florida 34209

United States

VM Clintrials

Miami Lakes, Florida 33014

United States

Medquest Translational Sciences

Miami Lakes, Florida 33016

United States

Metropolitan Clinical Research Center

Tamarac, Florida 33321

United States

Covenant Critical Pulmonary Care

East Point, Georgia 30344

United States

Accelerated Clinical Trials

Snellville, Georgia 30078

United States

Bioluminux Clinical Research Illinois

Naperville, Illinois 60540

United States

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana 46383

United States

AMR Clinical - Lexington

Lexington, Kentucky 40509

United States

Patient First Clinical Trials (PFCTRIALS)

Lutherville, Maryland 21093

United States

Verexa Health

Dearborn, Michigan 48126

United States

Oakland Medical Research

Troy, Michigan 48085

United States

AMR Clinical - Las Vegas

Las Vegas, Nevada 89119

United States

Bioluminux Clinical Research New Jersey

Hamilton, New Jersey 08690

United States

Velocity Clinical Research - Binghamton

Binghamton, New York 13905

United States

Brooklyn Clinical Research

Brooklyn, New York 11226

United States

CRC Kings Mountain

Kings Mountain, North Carolina 28086

United States

Remington-Davis, Inc.

Columbus, Ohio 43215

United States

Hometown Urgent Care - Milford

Milford, Ohio 45150

United States

Tekton Research

Edmond, Oklahoma 73013

United States

Velocity Clinical Research - Medford

Medford, Oregon 97504

United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania 15801

United States

Preferred Primary Care Physicians - St. Clair

Pittsburgh, Pennsylvania 15423

United States

Guthrie Medical Group, PC

Sayre, Pennsylvania 18840

United States

Velocity Clinical Research - Anderson

Anderson, South Carolina 29621

United States

Clinical Research of Rock Hill

Rock Hill, South Carolina 29732

United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina 29303

United States

Velocity Clinical Research - Union

Union, South Carolina 29379

United States

Zenos Clinical Research, LLC

Dallas, Texas 75230

United States

Activian Clinical Research - Kingwood

Kingwood, Texas 77339

United States

Epic Clinical Research, LLC

Lewisville, Texas 75057

United States

Activian Clinical Research - Tomball

Tomball, Texas 77375

United States

FutureMeds Liverpool

Bromborough, CH62 6EE

United Kingdom

FutureMeds Glasgow

Glasgow, G20 7BE

United Kingdom

FutureMeds London

London, NW10 2PB

United Kingdom

Clinicalysis

London, RM1 1BH

United Kingdom

ProMed Innovations Clinical Research

London, SE6 4LF

United Kingdom

Bioluminux Clinical Research Milton Keynes

Milton Keynes, MK15 0DU

United Kingdom

Bioluminux Clinical Research Wolverhampton

Wolverhampton, WV9 5HB

United Kingdom