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Protocol NumberUPB-CP-06
Not yet recruiting

2025-10-31 - 2029-06-26

Not yet recruiting8

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy and safety of Verekitug (UPB-101) in participants with moderate to severe chronic obstructive pulmonary disease (COPD).

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Parexel International Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/06

Investigators and Locations

Principal Investigator Pin-Kuei Fu 臨床試驗科
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鄭舒帆 Division of Thoracic Medicine
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kai-Ling Lee Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃國棟 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 何明霖 Division of Thoracic Medicine
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chun-Hua Wang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Moderate to severe chronic obstructive pulmonary disease (COPD)

Objectives

Primary Objective: Evaluate the effect of verekitug on COPD exacerbations Secondary Objective: Efficacy Evaluate the effect of verekitug on pulmonary function assessments Evaluate the effect of verekitug on severe COPD exacerbations Evaluate the effect of verekitug on health-related quality of life Secondary Objective: Safety Evaluate the safety of verekitug in COPD participants

Test Drug

UPB-101

Active Ingredient

Verekitug
Verekitug

Dosage Form

subcutaneous injection

Dosage

400mg

Endpoints

The annualized rate of moderate or severe COPD exacerbations over the 108-week treatment period

Inclution Criteria

● Age ≥40 to ≤85 years at the time of signing the participant consent form.

● Physician-diagnosed COPD for >12 months.

● Current or former smokers with a smoking history of 10 pack-years or more.

● Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70 after bronchodilator use, and FEV1 predictive value >30% and ≤80% after bronchodilator use.

● History of ≥2 moderate exacerbations or ≥1 severe exacerbation within the previous year.

● Received background triple therapy (ICS, LABA, LAMA) for 3 months prior to randomization and a stable drug dose for 1 month or more prior to the first visit. Dual therapy with LABA and LAMA is permitted if there are contraindications to ICS.

● Adherence to background therapy ≥80% during the screening period and for at least 4 weeks.

Exclusion Criteria

● Moderate or severe COPD exacerbation (as defined by inclusion criteria) within 4 weeks prior to or during the screening period.

● Respiratory infection within 4 weeks prior to or during the screening period.

● Received oxygen therapy at a rate >4 liters/minute. Oxygen use at night for sleep apnea is permitted.

● Received systemic or biological immunosuppressant therapy for inflammatory or autoimmune diseases within 24 weeks or 5 half-lives (whichever is longer) prior to the first visit, excluding oral corticosteroids. Received cyclophosphamide and rituximab treatment within 12 months prior to the first visit.

● Currently diagnosed with asthma according to the 2023 Global Asthma Initiative guidelines or other recognized guidelines.

● History or evidence of a clinically significant lung disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss syndrome) or other lung or systemic disease associated with elevated peripheral eosinophil count.

● Chronic hypercapnia requiring bilevel positive airway pressure (BiPAP). Participants who require regular BiPAP due to acute COPD exacerbations are not excluded.

● Any of the following events within the 6 months prior to the first visit: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis, and arrhythmia, including paroxysmal (e.g., intermittent). Participants with persistent atrial fibrillation, defined as atrial fibrillation lasting at least 6 months, and whose atrial fibrillation has been controlled for at least 6 months by rate control strategies (i.e., selective beta-blockers, calcium channel blockers, pacemaker placement, digoxin, or ablation therapy) and a stable and appropriate level of anticoagulation therapy, may be considered for inclusion.

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    666 participants

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