A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients

NCT02272634 | Completed Phase 2 Results

• 1 other identifier: YPL-001_YJP-130403
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily \[BID\]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (4)

• Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events

  A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.

  Up to Day 56

• Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events

  A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.

  Up to Day 56

• Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events

  When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.

  Up to Day 56

• Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events

  When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.

  Up to Day 56

Secondary Outcomes (4)

• Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily

  Baseline to Day 55

• Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  Baseline to Day 55

• Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale)

  Baseline to Day 55

• Change From Baseline of Calculated Score From Duke Activity Status Index (DASI)

  Baseline to Day 55

Other Outcomes (11)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline (Screen) to Day 55

• Change From Baseline in Inspiratory Capacity (IC)

  Baseline (Screening) to Day 55

• Change From Baseline in Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio

  Baseline to Day 55

Study Arms (3)

Treatment A

EXPERIMENTAL

Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.

Drug: YPL-001 80 mg

Treatment B

EXPERIMENTAL

Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.

Drug: YPL-001 160 mg

Treatment C

PLACEBO COMPARATOR

Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days.

Drug: Placebo

Interventions

YPL-001 80 mg DRUG

twice daily \[BID\]

Also known as: Treatment A

Treatment A

YPL-001 160 mg DRUG

twice daily \[BID\]

Also known as: Treatment B

Treatment B

Placebo DRUG

twice daily \[BID\]

Treatment C

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and/or females, 30 to 85 years of age (inclusive).
• History of COPD for at least 12 months prior to screening.
• Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
• Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
• etc.

You may not qualify if:

• History of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
• History of more than 2 hospitalizations for COPD within 12 months prior to screening.
• Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
• Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
• etc.

Sponsors & Collaborators

• Yungjin Pharm. Co., Ltd.: lead

Study Sites (4)

UAB Lung Health Center

Birmingham, Alabama, 35249, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Temple Lung Center, Temple University Hospital

Philadelphia, Pennsylvania, 191140, United States

Location

Related Publications (4)

• Lee KH, Woo J, Kim J, Lee CH, Yoo CG. YPL-001 Shows Various Beneficial Effects against Cigarette Smoke Extract-Induced Emphysema Formation: Anti-Inflammatory, Anti-Oxidative, and Anti-Apoptotic Effects. Antioxidants (Basel). 2022 Dec 22;12(1):15. doi: 10.3390/antiox12010015.

  PMID: 36670877 DERIVED

• Lee SU, Lee S, Ro H, Choi JH, Ryu HW, Kim MO, Yuk HJ, Lee J, Hong ST, Oh SR. Piscroside C inhibits TNF-alpha/NF-kappaB pathway by the suppression of PKCdelta activity for TNF-RSC formation in human airway epithelial cells. Phytomedicine. 2018 Feb 1;40:148-157. doi: 10.1016/j.phymed.2018.01.012. Epub 2018 Jan 31.

  PMID: 29496167 DERIVED

• Ryu HW, Lee SU, Lee S, Song HH, Son TH, Kim YU, Yuk HJ, Ro H, Lee CK, Hong ST, Oh SR. 3-Methoxy-catalposide inhibits inflammatory effects in lipopolysaccharide-stimulated RAW264.7 macrophages. Cytokine. 2017 Mar;91:57-64. doi: 10.1016/j.cyto.2016.12.006. Epub 2016 Dec 21.

  PMID: 28011397 DERIVED

• Lee SU, Sung MH, Ryu HW, Lee J, Kim HS, In HJ, Ahn KS, Lee HJ, Lee HK, Shin DH, Lee Y, Hong ST, Oh SR. Verproside inhibits TNF-alpha-induced MUC5AC expression through suppression of the TNF-alpha/NF-kappaB pathway in human airway epithelial cells. Cytokine. 2016 Jan;77:168-75. doi: 10.1016/j.cyto.2015.08.262. Epub 2015 Aug 28.

  PMID: 26318254 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Yungjin Pharm. Co., Ltd.

mhlee2017@yungjin.co.kr

82-2-2041-8318

Study Officials

• Gerard J Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

• Mark T Dransfield, MD

  The Kirklin Clinic of UAB Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2014
• First Posted: October 23, 2014
• Study Start: June 4, 2015
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: July 14, 2023
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Locations

US (4)