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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
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
