Recruiting
Phase 3

Depemokimab

Sponsor:

GlaxoSmithKline

Code:

NCT06961214

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Depemokimab

Placebo

Study Details

Brief summary:

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT06961214

Start date

Jun 23, 2025

Status verified date

Apr, 2026

Completion date

Aug 21, 2029

Anticipated

Primary completion date

Aug 21, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the Informed consent
  • Elevated Blood Eosinophil Count (BEC)
  • Moderate to severe COPD with frequent exacerbations, defined as:

  • A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
  • A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of < 0.70 and a post-bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values
  • A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
  • COPD assessment test (CAT) score >=10 at Visit 1
  • Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.
  • Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1
  • Body mass index (BMI) >=16 kilogram per square meter (kg/m\^2)
  • Male and eligible female participants

Exclusion Criteria:

The following subjects are excluded:

  • Participants with a current or prior physician diagnosis of asthma
  • Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
  • Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1
  • Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure.
  • Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1
  • Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day
  • Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
  • Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\])
  • Unstable cardiovascular disease or arrhythmia
  • Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depemokimab

Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).

placebo comparator: Placebo

Participants will be administered placebo along with SoC.

Interventions

Depemokimab

Depemokimab as a sterile liquid formulation will be administered.

Placebo

Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered

Primary outcome measure

  • Annualized Rate of Moderate/Severe Exacerbations [ Time Frame: From Baseline up to Week 104 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Sheffield, Alabama, United States, 35660

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Aaron Karr

GSK Investigational Site

Recruiting

Aurora, Colorado, United States, 80012

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nathaniel Moore

GSK Investigational Site

Recruiting

Brooksville, Florida, United States, 346135

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Salman Muddassir

GSK Investigational Site

Recruiting

Doral, Florida, United States, 33172

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Felipe Gascon-Rodon

GSK Investigational Site

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Frank Hull

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33122

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Armando Ropero Cartier

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33125

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ibrahim Menendez-Perez

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33155

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jacqueline Diaz

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33165

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramses Vega

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33175

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mireya Garcia

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33176

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Juvenal Martinez

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33176

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ariel Ramirez Navarro

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eduardo Andre

GSK Investigational Site

Recruiting

Naples, Florida, United States, 34102

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lisette Delgado Sanchez

GSK Investigational Site

Recruiting

New Port Richey, Florida, United States, 34653

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jaime Kratz

GSK Investigational Site

Recruiting

Ocala, Florida, United States, 34471

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Raj Karunakara

GSK Investigational Site

Recruiting

Orlando, Florida, United States, 32825

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Humberto Cruz

GSK Investigational Site

Recruiting

Ormond Beach, Florida, United States, 32174

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Dany Obeid

GSK Investigational Site

Recruiting

Palmetto Bay, Florida, United States, 33157

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Luis Hernandez Rosado

GSK Investigational Site

Recruiting

St. Petersburg, Florida, United States, 33704

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hudman Hoo

GSK Investigational Site

Recruiting

Adairsville, Georgia, United States, 30103

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Richmond

GSK Investigational Site

Recruiting

Cordele, Georgia, United States, 31015

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Kavtaradze

GSK Investigational Site

Recruiting

East Point, Georgia, United States, 30344

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ngozika Orjioke

GSK Investigational Site

Recruiting

Morrow, Georgia, United States, 30260

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Marie Walton

GSK Investigational Site

Recruiting

Boise, Idaho, United States, 83702

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Bill Laitinen

GSK Investigational Site

Recruiting

Chicago, Illinois, United States, 60608

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Thomas Wade

GSK Investigational Site

Recruiting

Baton Rouge, Louisiana, United States, 70816

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alexander Mulamula

GSK Investigational Site

Recruiting

Lafayette, Louisiana, United States, 70506

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Patrick Moore

GSK Investigational Site

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Green

GSK Investigational Site

Recruiting

Bangor, Maine, United States, 04401

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Paul Shapero

GSK Investigational Site

Recruiting

Rockville, Maryland, United States, 20854

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Asefa Mekonnen

GSK Investigational Site

Recruiting

Allen Park, Michigan, United States, 48101

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed Talib Raza

GSK Investigational Site

Recruiting

Detroit, Michigan, United States, 48202

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Daniel Ouellette

GSK Investigational Site

Recruiting

Garden City, Michigan, United States, 48135

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Renee Dwaihy

GSK Investigational Site

Recruiting

Troy, Michigan, United States, 48085

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jay Sandberg

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vishisht Mehta

GSK Investigational Site

Recruiting

Moorestown, New Jersey, United States, 08057

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Emilio Mazza

GSK Investigational Site

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Allen Silvey

GSK Investigational Site

Recruiting

Mount Kisco, New York, United States, 10549

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lisa Youkeles

GSK Investigational Site

Recruiting

New Windsor, New York, United States, 12553

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sashi Makam

GSK Investigational Site

Recruiting

Shelby, North Carolina, United States, 28152

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Christian Martin

GSK Investigational Site

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sandeep Bansal

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gerard Criner

GSK Investigational Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Farhan Siddiqui

GSK Investigational Site

Recruiting

Union, South Carolina, United States, 29379

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joseph Boscia

GSK Investigational Site

Recruiting

Knoxville, Tennessee, United States, 37919

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Bashar Bargoty

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78744

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sean Gilbey

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75254

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Shakil Ahmed

GSK Investigational Site

Recruiting

El Paso, Texas, United States, 79902-1123

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Carlo Hatem

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77094

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Murtuza Ahmed

GSK Investigational Site

Recruiting

Lampasas, Texas, United States, 76550

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vanna Gold

GSK Investigational Site

Recruiting

Richmond, Texas, United States, 77407

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Samira Khan

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Danielle Coulter

GSK Investigational Site

Recruiting

Webster, Texas, United States, 77598

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Regina Pillai

GSK Investigational Site

Recruiting

Morgantown, West Virginia, United States, 26505-0423

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ward Paine

More Information

Sponsor

GlaxoSmithKline

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

  • Depemokimab
  • GSK3511294
  • Eosinophilic phenotype
  • Chronic obstructive pulmonary disease
  • COPD
  • Moderate COPD
  • Severe COPD
  • Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
  • Exacerbations
  • Placebo
  • Type 2 inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-04-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.