Clinical trial NCT06496620: A Study to Evaluate Solrikitug in Participants With COPD (ZION)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: COPD
Lead sponsor: Uniquity One (UNI)
Sponsor class: INDUSTRY
Collaborators: name: DevPro Biopharma
First posted: 2024-07-11
Enrollment: 171
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in blood eosinophil counts
timeFrame: Through week 12
Secondary outcomes:
measure: Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Through week 12 To week 28
Other outcomes:
Locations:
city: Surprise
country: United States
facility: Research Site 051
state: Arizona
city: Tempe
country: United States
facility: Research Site 033
state: Arizona
city: Lancaster
country: United States
facility: Research Site 031
state: California
city: Los Angeles
country: United States
facility: Research Site 032
state: California
city: Newport Beach
country: United States
facility: Research Site 018
state: California
city: Oxnard
country: United States
facility: Research Site 041
state: California
city: Englewood
country: United States
facility: Research Site 020
state: Colorado
city: Clearwater
country: United States
facility: Research Site 049
state: Florida
city: Clearwater
country: United States
facility: Research Site 002
state: Florida
city: Cutler Bay
country: United States
facility: Research Site 035
state: Florida
city: Miami
country: United States
facility: Research Site 052
state: Florida
city: Miami
country: United States
facility: Research Site 004
state: Florida
city: Orlando
country: United States
facility: Research Site 013
state: Florida
city: Sarasota
country: United States
facility: Research Site 007
state: Florida
city: Tampa
country: United States
facility: Research Site 001
state: Florida
city: Rincon
country: United States
facility: Research Site 003
state: Georgia
city: Meridian
country: United States
facility: Research Site 021
state: Idaho
city: Merrillville
country: United States
facility: Research Site 022
state: Indiana
city: Lexington
country: United States
facility: Research Site 042
state: Kentucky
city: Dartmouth
country: United States
facility: Research Site 017
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site 037
state: Michigan
city: Saint Charles
country: United States
facility: Research Site 009
state: Missouri
city: Missoula
country: United States
facility: Research Site 062
state: Montana
city: Henderson
country: United States
facility: Research Site 015
state: Nevada
city: Cortland
country: United States
facility: Research Site 044
state: New York
city: Horseheads
country: United States
facility: Research Site 043
state: New York
city: Charlotte
country: United States
facility: Research Site 050
state: North Carolina
city: Gastonia
country: United States
facility: Research Site 005
state: North Carolina
city: High Point
country: United States
facility: Research Site 008
state: North Carolina
city: Huntersville
country: United States
facility: Research Site 039
state: North Carolina
city: Wilmington
country: United States
facility: Research Site 006
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site 014
state: North Carolina
city: Columbus
country: United States
facility: Research Site 036
state: Ohio
city: Grants Pass
country: United States
facility: Research Site 047
state: Oregon
city: Medford
country: United States
facility: Research Site 011
state: Oregon
city: Pittsburgh
country: United States
facility: Research Site 053
state: Pennsylvania
city: Anderson
country: United States
facility: Research Site 023
state: South Carolina
city: Columbia
country: United States
facility: Research Site 028
state: South Carolina
city: Greenville
country: United States
facility: Research Site 027
state: South Carolina
city: Rock Hill
country: United States
facility: Research Site 010
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site 024
state: South Carolina
city: Union
country: United States
facility: Research Site 029
state: South Carolina
city: Hendersonville
country: United States
facility: Research Site 040
state: Tennessee
city: Knoxville
country: United States
facility: Research Site 048
state: Tennessee
city: Boerne
country: United States
facility: Research Site 016
state: Texas
city: Houston
country: United States
facility: Research Site 025
state: Texas
city: McKinney
country: United States
facility: Research Site 012
state: Texas
city: Hampton
country: United States
facility: Research Site 019
state: Virginia
Study officials:
affiliation: Vice President, Clinical Research
name: Andrew W Lee, MD
role: STUDY_DIRECTOR
References: