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Protocol NumberUPB-CP-06
Not yet recruiting

2025-10-31 - 2029-06-26

Phase II

Not yet recruiting8

A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess 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

    Upstream Bio, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 Chung-Yu Chen Division of General Internal Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

  • 陳彥甫 Division of General Internal Medicine
  • 陳祐易 Division of General Internal Medicine

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 Chun-Hua Wang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

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 Kai-Ling Lee
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Moderate-to-severe COPD

Objectives

To assess the effect of verekitug on COPD exacerbations To assess the effect of verekitug on lung function assessments

Test Drug

Injection

Active Ingredient

Verekitug

Dosage Form

220

Dosage

400mg

Endpoints

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

Inclution Criteria

• Age >40 to <85 years 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.
Note: current smokers are defined as participants who are active smokers with 10 or more
pack-years of smoking, including cigarettes, cigars, pipes, e-cigarettes, etc. Former smokers
are participants who were active smokers with 10 or more pack-year history of smoking and
who have stopped completely for at least 6 months prior to Visit 1.
• 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.
a. At least one exacerbation should have occurred while the participant was taking
inhaled corticosteroids (ICS)/long-acting muscarinic antagonists (LAMA)/long-acting
beta-agonists (LABA) or LAMA/LABA if ICS is contraindicated.
b. At least one moderate exacerbation should have required systemic corticosteroids
(with or without antibiotics).
Moderate exacerbation is defined as acute exacerbation of COPD (AECOPD) that requires
systemic corticosteroids (intramuscular [IM], intravenous [IV], or oral) or antibiotics. Severe
exacerbation is defined as AECOPD requiring hospitalization or observation >24 hours in
emergency room or urgent care facility.
• 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.
• Are >80% compliant with all COPD background therapy for at least 4 consecutive weeks
during the screening period.

Exclusion Criteria

• Acute 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 (e.g., azithromycin therapy), unless on stable therapy for at least 3
months before Visit 1.
• Current diagnosis of asthma according to the 2023 Global Initiative for Asthma (GINA)
guidelines or other accepted guidelines. Note: Participants with a past diagnosis of asthma that
was documented to be incorrect by a healthcare provider/investigator may be included.
• History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g.,
pulmonary fibrosis, chronic hypercapnia requiring 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 Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    666 participants

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