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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: Uniquity One (UNI)

NCT ID: NCT06496620

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Biological: Solrikitug low dose (biological), Biological: Solrikitug high dose (biological), Placebo (other)
How long the study runs
Study runs about 30 months (dates as stated)
About the drug or intervention
Biological: Solrikitug low dose — biological: Solrikitug subcutaneous injection · Biological: Solrikitug high dose — biological: Solrikitug subcutaneous injection · Placebo — other: Placebo subcutaneous injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 75 Years
Who
All
Number of participants
182
Started
2024-08-14
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for copd
  • • Phase2 - 182 participants
  • • 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)

Who can take part?

  • • Ages 40 Years to 75 Years
  • • Diagnosed with copd

Where?

  • • Wythenshawe - The Medicines Evaluation Unit, an IQVIA business
  • • Bradford - Bradford Teaching Hospitals NHS Foundation Trust
  • • High Wycombe - Velocity Clinical Research High Wycombe
  • • London - Velocity Clinical Research - Bristol
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

COPD

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓causing symptoms (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...

Who cannot take part

  • ✗Female participant who is pregnant or breastfeeding.
  • ✗Any other lung disease than COPD that in the opinion of the Investigator, the severity of the disorder would...
  • ✗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.
See the full 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.

Where Is This Study? (5 UK sites)

The Medicines Evaluation Unit, an IQVIA business

Wythenshawe M23 9QZGB, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford BD9 6RJ, United Kingdom

Hospital R&D contact (matched)

Jane Dennison

bradfordresearch.applications@bthft.nhs.uk01274 382575

Velocity Clinical Research High Wycombe

High Wycombe HP11 2QW, United Kingdom

Velocity Clinical Research - Bristol

London N12 8BU, United Kingdom

Queen Anne Street Medical Centre

London W1T 6AH, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08