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NCT06496620 | RECRUITING | COPD

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

Uniquity One (UNI)

Brief Summary:

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).

Condition or disease

COPD

Intervention/treatment

Biological: Solrikitug low dose

Biological: Solrikitug high dose

Placebo

Phase

PHASE2

Detailed Description:

This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD. Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.

Study Type : INTERVENTIONAL
Estimated Enrollment : 171 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-08-14
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * At least 40 years of age and no older than 75 years.
  • * Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
  • * 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).
  • * Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
  • * Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.
Exclusion Criteria
  • * Female participant who is pregnant or breastfeeding.
  • * 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.
  • * 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.
  • * 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.
  • * Undergone major lung surgery, within 1 year of Screening Visit 1.
  • * Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
A Study to Evaluate Solrikitug in Participants With COPD (ZION)

Location Details

NCT06496620

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Research Site 051

Surprise, Arizona, United States, 85378

RECRUITING

United States, Arizona

Research Site 033

Tempe, Arizona, United States, 85281

RECRUITING

United States, California

Research Site 031

Lancaster, California, United States, 93534

RECRUITING

United States, California

Research Site 032

Los Angeles, California, United States, 90017

RECRUITING

United States, California

Research Site 018

Newport Beach, California, United States, 92663

RECRUITING

United States, California

Research Site 041

Oxnard, California, United States, 93036

RECRUITING

United States, Colorado

Research Site 020

Englewood, Colorado, United States, 80110

RECRUITING

United States, Florida

Research Site 049

Clearwater, Florida, United States, 33756

RECRUITING

United States, Florida

Research Site 002

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

Research Site 035

Cutler Bay, Florida, United States, 33189

RECRUITING

United States, Florida

Research Site 052

Miami, Florida, United States, 33184

RECRUITING

United States, Florida

Research Site 004

Miami, Florida, United States, 33186

RECRUITING

United States, Florida

Research Site 013

Orlando, Florida, United States, 32825

RECRUITING

United States, Florida

Research Site 007

Sarasota, Florida, United States, 34239

RECRUITING

United States, Florida

Research Site 001

Tampa, Florida, United States, 33606

RECRUITING

United States, Georgia

Research Site 003

Rincon, Georgia, United States, 31326

RECRUITING

United States, Idaho

Research Site 021

Meridian, Idaho, United States, 83642

RECRUITING

United States, Indiana

Research Site 022

Merrillville, Indiana, United States, 46410

RECRUITING

United States, Kentucky

Research Site 042

Lexington, Kentucky, United States, 40503

RECRUITING

United States, Massachusetts

Research Site 017

Dartmouth, Massachusetts, United States, 02747

RECRUITING

United States, Road cancer

Research Site 037

Farmington Hills, Road cancer, United States, 48336

NOT YET RECRUITING

United States, Missouri

Research Site 009

Saint Charles, Missouri, United States, 63301

RECRUITING

United States, Montana

Research Site 062

Missoula, Montana, United States, 59808

RECRUITING

United States, Nevada

Research Site 015

Henderson, Nevada, United States, 89052

RECRUITING

United States, New York

Research Site 044

Cortland, New York, United States, 13045

RECRUITING

United States, New York

Research Site 043

Horseheads, New York, United States, 14845

RECRUITING

United States, North Carolina

Research Site 050

Charlotte, North Carolina, United States, 28277

RECRUITING

United States, North Carolina

Research Site 005

Gastonia, North Carolina, United States, 28054

RECRUITING

United States, North Carolina

Research Site 008

High Point, North Carolina, United States, 27260

RECRUITING

United States, North Carolina

Research Site 039

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, North Carolina

Research Site 006

Wilmington, North Carolina, United States, 28401

NOT YET RECRUITING

United States, North Carolina

Research Site 014

Winston-Salem, North Carolina, United States, 27103

RECRUITING

United States, Ohio

Research Site 036

Columbus, Ohio, United States, 43215

RECRUITING

United States, Oregon

Research Site 047

Grants Pass, Oregon, United States, 97257

RECRUITING

United States, Oregon

Research Site 011

Medford, Oregon, United States, 97504

RECRUITING

United States, Pennsylvania

Research Site 053

Pittsburgh, Pennsylvania, United States, 15241

RECRUITING

United States, South Carolina

Research Site 023

Anderson, South Carolina, United States, 29621

RECRUITING

United States, South Carolina

Research Site 028

Columbia, South Carolina, United States, 29204

RECRUITING

United States, South Carolina

Research Site 027

Greenville, South Carolina, United States, 29615

RECRUITING

United States, South Carolina

Research Site 010

Rock Hill, South Carolina, United States, 29732

RECRUITING

United States, South Carolina

Research Site 024

Spartanburg, South Carolina, United States, 29303

RECRUITING

United States, South Carolina

Research Site 029

Union, South Carolina, United States, 29379

RECRUITING

United States, Tennessee

Research Site 040

Hendersonville, Tennessee, United States, 37075

RECRUITING

United States, Tennessee

Research Site 048

Knoxville, Tennessee, United States, 37909

NOT YET RECRUITING

United States, Texas

Research Site 016

Boerne, Texas, United States, 78006

RECRUITING

United States, Texas

Research Site 025

Houston, Texas, United States, 77070

RECRUITING

United States, Texas

Research Site 012

McKinney, Texas, United States, 75071

RECRUITING

United States, Virginia

Research Site 019

Hampton, Virginia, United States, 23666