BridgeMD
Study to assess whether Verekitug can improve the control of Chronic Obstructive Pulmonary Disease (COPD)
EU CTIS ID: 2025-520488-42-00
What this study is testing
To assess the effect of verekitug on chronic obstructive pulmonary disease (COPD) exacerbations
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females ≥ 40 to ≤ 85 years of age at the time of signing the informed consent.
- Physician diagnosis of COPD for ≥12 months.
- Current or former smokers with a smoking history of 10 pack-years or more.
- Post-bronchodilator FEV1/forced vital capacity ratio < 0.70 and predicted post-bronchodilator FEV1 > 30% and ≤ 80%).
- Modified Medical Research Council dyspnea scale grade ≥2.
- Documented history of ≥ 2 moderate or ≥ 1 severe exacerbation within the year prior to inclusion.
You likely can't join if
- Moderate or severe exacerbation of COPD (as defined in inclusion criteria) within 4 weeks prior to or during the screening period.
- Respiratory tract infection within 4 weeks prior to or during the screening period.
- Treatment with oxygen of >4 L/minute. Nocturnal oxygen use for sleep apnea is allowed.
- Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1.
- Treatment with macrolides (eg, azithromycin therapy), unless on stable therapy for at least 3 months before Visit 1. Macrolides for the treatment of acute infection or AECOPD is acceptable, with the last dose of macrolide at least 4 weeks prior to Visit 1.
- Current diagnosis of asthma according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
See the full eligibility criteria
- Males and females ≥ 40 to ≤ 85 years of age at the time of signing the informed consent.
- Physician diagnosis of COPD for ≥12 months.
- Current or former smokers with a smoking history of 10 pack-years or more.
- Post-bronchodilator FEV1/forced vital capacity ratio < 0.70 and predicted post-bronchodilator FEV1 > 30% and ≤ 80%).
- Modified Medical Research Council dyspnea scale grade ≥2.
- Documented history of ≥ 2 moderate or ≥ 1 severe exacerbation within the year prior to inclusion.
- Background triple therapy (ICS, LABA, LAMA) for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit 1. If ICS is contraindicated, double therapy with LABA and LAMA are allowed, as per investigator discretion.
- Are ≥ 80% compliant with all COPD background therapy for at least 4 consecutive weeks during the screening period.
- Moderate or severe exacerbation of COPD (as defined in inclusion criteria) within 4 weeks prior to or during the screening period.
- Respiratory tract infection within 4 weeks prior to or during the screening period.
- Treatment with oxygen of >4 L/minute. Nocturnal oxygen use for sleep apnea is allowed.
- Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1.
- Treatment with macrolides (eg, azithromycin therapy), unless on stable therapy for at least 3 months before Visit 1. Macrolides for the treatment of acute infection or AECOPD is acceptable, with the last dose of macrolide at least 4 weeks prior to Visit 1.
- Current diagnosis of asthma according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
- History or evidence of a clinically meaningful pulmonary condition other than COPD (eg, pulmonary fibrosis, chronic hypercapnia requiring bilevel positive airway pressure (BiPAP), sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Philippines
- Thailand
- United Kingdom
- India
- Malaysia
- Ukraine
- Vietnam
- Turkey
- Argentina
- Chile
- Korea, Republic of
- Taiwan
- Georgia
- Mexico
- United States
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Philippines; Thailand; United Kingdom; India; Malaysia and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.