HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST CRLF2 for Chronic obstructive pulmonary disease (COPD)

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Annualized rate of moderate or severe COPD exacerbation events compared with placebo over 108 weeks of treatment.","definition_or_measurement_approach":"Annualized rate of moderate or severe COPD exacerbation events compared with placebo measured over 108 weeks of treatment."}

Secondary endpoints

• {"endpoint_text":"- Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared with placebo from baseline to Week 60.","definition_or_measurement_approach":"Change from baseline to Week 60 in pre-bronchodilator FEV1 compared with placebo."}
• {"endpoint_text":"- Annualized rate of severe COPD exacerbation events compared with placebo over 108 weeks of treatment.","definition_or_measurement_approach":"Annualized rate of severe COPD exacerbations compared with placebo measured over 108 weeks of treatment."}
• {"endpoint_text":"- Change in St. George’s Respiratory Questionnaire (SGRQ) total score compared with placebo from baseline to Week 60.","definition_or_measurement_approach":"Change from baseline to Week 60 in SGRQ total score compared with placebo."}
• {"endpoint_text":"- Proportion of participants with SGRQ improvement of >4 points compared with placebo at Week 60.","definition_or_measurement_approach":"Proportion of participants achieving >4-point improvement in SGRQ at Week 60 compared with placebo."}
• {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.","definition_or_measurement_approach":"Incidence and grading of TEAEs and SAEs during treatment using CTCAE v5.0."}
• {"endpoint_text":"- Serum concentrations of verekitug and PK profile.","definition_or_measurement_approach":"Measurement of serum concentrations and pharmacokinetic profiling of verekitug."}
• {"endpoint_text":"- Incidence of anti-drug antibodies (ADAs) during the study (including the post-treatment follow-up period).","definition_or_measurement_approach":"Incidence of ADAs assessed during the study and post-treatment follow-up."}

Methods

• Social media / digital toolkit: patient-facing digital outreach materials (social media toolkits / digital toolkits) are provided (documents titled 'Recruitment Social Media' or 'Digital Toolkit') - country-specific versions available (e.g., Germany, Hungary, Ireland, Spain, Poland, Bulgaria, Latvia, Romania, Lithuania, Slovakia, Czechia).
• Posters: printed recruitment posters for clinic/display use (country-specific posters present: e.g., K2_* Recruitment Poster files for multiple countries).
• Brochures / Study information brochures: patient information brochures distributed in clinics (K2_* Recruitment Brochure files present for multiple countries).
• Recruitment procedure descriptions (K1): country-level recruitment procedure documents outlining local recruitment processes and responsibilities (K1 files present for Bulgaria, Latvia, Ireland, Romania, Germany, Poland, Hungary, Czechia, Spain, Slovakia, Lithuania).
• Recruitment website / Consent navigator: online consent navigator and recruitment website materials (documents: 'Recruitment Website Consent navigator', 'Consent Navigator' subject materials present for several countries e.g., Bulgaria, Latvia, Ireland, Romania, Lithuania).
• Clinician outreach / referral: 'Dear Colleague' letters, referral cards and clinician-targeted materials to encourage referrals from healthcare professionals (documents present for Hungary and other countries).
• Local translations & multi-language materials: consent and recruitment materials provided in local languages and, in some countries, alternative languages (e.g., Russian in Latvia/Lithuania) to reach local patient populations.

Bulgaria

Earliest CTIS Part Ii Submission Date

18-08-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

217

Number Of Participants

62

Latvia

Earliest CTIS Part Ii Submission Date

21-08-2025

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

208

Number Of Participants

9

Ireland

Earliest CTIS Part Ii Submission Date

19-08-2025

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

211

Number Of Participants

9

Romania

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

223

Number Of Participants

19

Germany

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

217

Number Of Participants

32

Poland

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

223

Number Of Participants

64

Hungary

Earliest CTIS Part Ii Submission Date

21-08-2025

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

209

Number Of Participants

22

Czechia

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

208

Number Of Participants

18

Spain

Earliest CTIS Part Ii Submission Date

19-08-2025

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

213

Number Of Participants

24

Slovakia

Earliest CTIS Part Ii Submission Date

19-08-2025

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

218

Number Of Participants

19

Lithuania

Earliest CTIS Part Ii Submission Date

21-08-2025

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

208

Number Of Participants

9

Primary sponsor

Full Name

Upstream Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: 1,10,11,12,13,2,5,6,8,9 (operational CRO functions; contact: Clinicaltrial.Enquiries@parexel.com)

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,2,5,6,8,9 (contact: Clinicaltrial.Enquiries@parexel.com)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sponsor duties codes: 4 (laboratory services) (contact: timothy.myers@bioagilytix.com)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Site training (sponsor duties code 15) (contact: lb-privacy@advarra.com)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Sponsor duties code 4 (central laboratory) (contact: clinicaltrials@bcl.eurofins.com)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 3,6,7 (electronic data capture/technology) (contact: info@medidata.com)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Sponsor duties code 15 (Spirometry and FeNO, eCOA) (contact: customercare@clario.com)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duties value: 'Spirometry, FeNO and eCOA.' (contact: customercare@clario.com)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Sponsor duties code 6 (data monitoring/quality) (contact: Peter.Weiman@cluepoints.com)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Sponsor duties value: 'Patient Reimbursement' (contact: ClientCompliance@scoutclinical.com)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"Sponsor duties code 4 (laboratory/BDS responsibilities) (contact: jcanfield@immunologixlabs.com)","organisation_type":"Pharmaceutical company"}