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Phase 2Recruiting

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

Sponsored by Altesa Biosciences, Inc.

About this study

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.

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.