RECRUITING

A Study to Evaluate Solrikitug in Participants With COPD (ZION)

Talk to us

Conditions

COPD

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

Official Title

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease (ZION)

Quick Facts

Study Start:2024-08-14
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06496620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 40 years of age and no older than 70 years.
  2. * Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
  3. * At Screening FEV1/FVC ratio must be \<0.70, and Post-bronchodilator FEV1 must be ≥40% to \<80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
  4. * Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
  5. * Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.
  1. * Female participant who is pregnant or breastfeeding.
  2. * Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
  3. * Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
  4. * Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
  5. * Undergone major lung surgery, within 1 year of Screening Visit 1.
  6. * Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.

Contacts and Locations

Study Contact

Uniquity One Clinical Trials
CONTACT
484-267-2500
ClinicalTrials@uniquity.com
Anushri Walsh
CONTACT
973-983-3700
awalsh@devprobiopharma.com

Principal Investigator

Andrew W Lee, MD
STUDY_DIRECTOR
Vice President, Clinical Research

Study Locations (Sites)

Research Site 018
Newport Beach, California, 92663
United States
Research Site 020
Englewood, Colorado, 80110
United States
Research Site 002
Clearwater, Florida, 33765
United States
Research Site 004
Miami, Florida, 33186
United States
Research Site 013
Orlando, Florida, 32825
United States
Research Site 007
Sarasota, Florida, 34239
United States
Research Site 001
Tampa, Florida, 33606
United States
Research Site 003
Rincon, Georgia, 31326
United States
Research Site 021
Meridian, Idaho, 83642
United States
Research Site 022
Merrillville, Indiana, 46410
United States
Research Site 017
South Dartmouth, Massachusetts, 02747
United States
Research Site 009
Saint Charles, Missouri, 63301
United States
Research Site 015
Henderson, Nevada, 89052
United States
Research Site 005
Gastonia, North Carolina, 28054
United States
Research Site 008
High Point, North Carolina, 27260
United States
Research Site 006
Wilmington, North Carolina, 28401
United States
Research Site 014
Winston-Salem, North Carolina, 27103
United States
Research Site 011
Medford, Oregon, 97504
United States
Research Site 023
Anderson, South Carolina, 29621
United States
Research Site 010
Rock Hill, South Carolina, 29732
United States
Research Site 024
Spartanburg, South Carolina, 29303
United States
Research Site 016
Boerne, Texas, 78006
United States
Research Site 025
Houston, Texas, 77070
United States
Research Site 012
McKinney, Texas, 75071
United States
Research Site 019
Hampton, Virginia, 23666
United States

Collaborators and Investigators

Sponsor: Uniquity One (UNI)

  • Andrew W Lee, MD, STUDY_DIRECTOR, Vice President, Clinical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-14
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-08-14
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • COPD