Study to assess whether Verekitug can improve the control of Chronic Obstructive Pulmonary Disease (COPD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Upstream Bio Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

17 Sep 2025 → ongoing

Decision date (initial)

2025-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Upstream Bio, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Safety, Efficacy

To assess the effect of verekitug on chronic obstructive pulmonary disease (COPD) exacerbations

Secondary objectives 6

1. To assess the effect of verekitug on lung function assessments
2. To assess the effect of verekitug on severe COPD exacerbations
3. To assess the effect of verekitug on health-related quality of life
4. To assess the safety of verekitug in participants with COPD
5. To assess the pharmacokinetics (PK) of verekitug
6. To assess the immunogenicity of verekitug

Conditions and MedDRA coding

Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Males and females ≥ 40 to ≤ 85 years of age at the time of signing the informed consent.
2. Physician diagnosis of COPD for ≥12 months.
3. Current or former smokers with a smoking history of 10 pack-years or more.
4. Post-bronchodilator FEV1/forced vital capacity ratio < 0.70 and predicted post-bronchodilator FEV1 > 30% and ≤ 80%).
5. Modified Medical Research Council dyspnea scale grade ≥2.
6. Documented history of ≥ 2 moderate or ≥ 1 severe exacerbation within the year prior to inclusion.
7. 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.
8. Are ≥ 80% compliant with all COPD background therapy for at least 4 consecutive weeks during the screening period.

Exclusion criteria 7

1. Moderate or severe exacerbation of COPD (as defined in inclusion criteria) within 4 weeks prior to or during the screening period.
2. Respiratory tract infection within 4 weeks prior to or during the screening period.
3. Treatment with oxygen of >4 L/minute. Nocturnal oxygen use for sleep apnea is allowed.
4. 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.
5. 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.
6. Current diagnosis of asthma according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualized rate of moderate or severe COPD exacerbation events compared with placebo over 108 weeks of treatment.

Secondary endpoints 7

1. Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared with placebo from baseline to Week 60.
2. Annualized rate of severe COPD exacerbation events compared with placebo over 108 weeks of treatment.
3. Change in St. George’s Respiratory Questionnaire (SGRQ) total score compared with placebo from baseline to Week 60.
4. Proportion of participants with SGRQ improvement of >4 points compared with placebo at Week 60.
5. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
6. Serum concentrations of verekitug and PK profile.
7. Incidence of anti-drug antibodies (ADAs) during the study (including the post-treatment follow-up period).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Upstream Bio Inc.

Sponsor organisation

Upstream Bio Inc.

Address

890 Winter Street Suite 20

City

Waltham

Postcode

02451-1470

Country

United States

Scientific contact point

Organisation

Upstream Bio Inc.

Contact name

Justin Salciccioli

Public contact point

Organisation

Upstream Bio Inc.

Contact name

Justin Salciccioli

Third parties 10

Locations

11 EU/EEA countries · 131 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 133 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications