Clinical Trials
Sponsor-initiated trials (SIT), post-marketing surveillance, and investigator-initiated studies. These are the trials I have run in the Division of Allergy and Clinical Immunology at Chungbuk National University Hospital, in patients with asthma, allergic rhinitis, urticaria and drug allergy.
12
Trials and PMS
12
Principal Investigator (PI)
7
Randomized controlled trials
5
Post-marketing surveillance
Randomized controlled trials 7
| Period | Trial | Role |
|---|---|---|
| 2025.6 - Ongoing | Tozorakimab Uncontrolled asthmaUMBRIEL: A phase 2b, multicenter, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy and safety of Tozorakimab in adults whose asthma is not controlled on medium- to high-dose inhaled corticosteroids (ICS) | PI |
| 2024.5 - 2025.11 | Verekitug (UPB-101) Severe asthmaUPB-CP-04: A phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial evaluating the efficacy and safety of Verekitug (UPB-101) in adults with severe asthma | PI |
| 2024.5 - Ongoing | CHF6001 (dry powder inhaler) Uncontrolled asthmaA 52-week, randomized, double-blind, multicenter, two-arm parallel-group trial evaluating the efficacy and safety of adding CHF6001 dry powder inhaler (3200 μg total per day) to maintenance therapy with medium- or high-dose inhaled corticosteroids plus a long-acting beta2-agonist | PI |
| 2024.5 - Ongoing | UIC202007 / UIC202306 combinationA multicenter, randomized, double-blind, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of UIC202007/UIC202306 given in combination | PI |
| 2023.7 - 2024.7 | Fexuclue 40 mg (fexuprazan) Chronic cough from gastroesophageal reflux diseaseA multicenter, parallel-group, double-blind, randomized, active-controlled, investigator-initiated phase 4 trial evaluating the efficacy and safety of Fexuclue 40 mg in patients with chronic cough from gastroesophageal reflux disease | PI |
| 2022.6 - 2023.2 | GCWB1001 (Lactobacillus plantarum) Respiratory healthA 12-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of GCWB1001 for respiratory function | PI |
| 2018.1 - 2019.4 | NVP-1703 (probiotic) Allergic rhinitisA 4-week, multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of NVP-1703 in allergic rhinitis | PI |
Post-marketing surveillance 5
| Period | Trial | Role |
|---|---|---|
| 2022.4 - 2024.10 | EnerzairA 24-week, prospective, open-label, multicenter, single-arm regulatory post-marketing surveillance (rPMS) study of Enerzair in routine clinical practice | PI |
| 2021.10 - 2022.12 | Monterizin capsules Asthma, perennial allergic rhinitisPost-marketing surveillance of Monterizin capsules to assess safety and efficacy in patients with both asthma and perennial allergic rhinitis | PI |
| 2020.12 - 2023.12 | Dupixent (dupilumab) AsthmaPost-marketing surveillance of Dupixent (dupilumab) in Korean patients with asthma | PI |
| 2019.6 - 2021.12 | Cinqair (reslizumab)Post-marketing surveillance to assess the safety and efficacy of Cinqair (reslizumab) | PI |
| 2019.5 - 2021.12 | Xolair (omalizumab)Post-marketing surveillance of Xolair prefilled syringe 150 mg/1 mL and 75 mg/0.5 mL and Xolair injection 150 mg | PI |