To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Expedition Therapeutics, Inc
Study ID
NCT07684820
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • EXPD-101/FXS7553 Dose 1 — DRUG
    Oral tablet
  • EXPD-101/FXS7553 Dose 2 — DRUG
    Oral tablet
  • Placebo — DRUG
    EXPD-101/FXS7553 - matching oral tablet.

Study Details

This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jul 11, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EXPD-101/FXS7553 Dose 1
    Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.
  • Experimental: EXPD-101/FXS7553 Dose 2
    Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.
  • Placebo Comparator: Placebo
    Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.

Primary Outcome Measure

Annualized rate of moderate and severe COPD exacerbations [ Time Frame: Over 52 Weeks ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
DM Clinical Research - PhoenixPhoenixArizona85012
Jade Perez
[email protected]
6232320800
Danielle Armas (PRINCIPAL_INVESTIGATOR)
California Medical Research Associates Inc.NorthridgeCalifornia91324
Chrismarie Goonarathne
[email protected]
8183491979
Jigar Kadakia (PRINCIPAL_INVESTIGATOR)
Lynn Institute of DenverAuroraColorado80012
Jacqueline Moore
[email protected]
7207083192
Timothy Colander (PRINCIPAL_INVESTIGATOR)
Clinical Site Partners, LLC Leesburg dba Flourish ResearchLeesburgFlorida34748
Jose Diaz
[email protected]
3524357240
Suncoast Research Group, LLC Miami - Little Havana dba Flourish ResearchMiamiFlorida33135
Jaymie Marquez
[email protected]
3052557452
Mark Kutner (PRINCIPAL_INVESTIGATOR)
Optimal Research SitesOrangeFlorida32763
Janyssa Balmes
[email protected]
3862185911
Kristyna Paradis (PRINCIPAL_INVESTIGATOR)
Centricity Research ColumbusRinconGeorgia31326
Ashley King
[email protected]
8437255067308
Maria Mascolo (PRINCIPAL_INVESTIGATOR)
DM Clinical Research-IndianapolisIndianapolisIndiana46254
Stephanie Samayoa
[email protected]
4632713179
Brandon Essink (PRINCIPAL_INVESTIGATOR)
Cotton O'Neil Clinical Research CenterTopekaKansas66606
Ambrosee Wilkinson
[email protected]
7853680741
Najm Salah (PRINCIPAL_INVESTIGATOR)
DM Clinical Research - PhiladelphiaPhiladelphiaPennsylvania19107
Michael Coyle
[email protected]
4453009011
David Wheeler (PRINCIPAL_INVESTIGATOR)
DM Clinical Research- TomballTomballTexas77375
Maryam Jamil
[email protected]
2815170550
Mustafa Naeem (PRINCIPAL_INVESTIGATOR)
Burke Internal Medicine, Inc.BurkeVirginia22015
Amy Aziz
[email protected]
7034559711
Nashwa Gabra (PRINCIPAL_INVESTIGATOR)

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DM Clinical Research - Phoenix· Phoenix, AZCalifornia Medical Research Associates Inc.· Northridge, CALynn Institute of Denver· Aurora, COClinical Site Partners, LLC Leesburg dba Flourish Research· Leesburg, FLSuncoast Research Group, LLC Miami - Little Havana dba Flourish Research· Miami, FLOptimal Research Sites· Orange, FL

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