Clinical Trials List
Protocol Number20220093
Active
2024-05-16 - 2026-12-31
Phase II
Recruiting4
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma
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Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Amgen Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳家閔 無
- 鄭孟軒 無
- 鄭至宏 無
- Inn-Wen Chong 無
- 莊政皓 無
- Ming-Ju Tsai 無
- jong rung Tsai 無
- Wei-An Chang 無
- Hung-Ling Huang 無
- 張旭良 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王俊隆 無
- Wei- Chang Huang 無
- JENG-SEN TSENG 無
- 趙文震 無
- 李柏昕 無
- 廖培雅 無
- 王振宇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Bing-Ru Wu 無
- 廖偉志 無
- 黃維俊 無
- Chih-Yen Tu 無
- Wen-Chien Cheng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Pai-Chien Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Asthma
Objectives
To describe the efficacy of
rocatinlimab in reducing
exacerbations
Test Drug
injection
Active Ingredient
Rocatinlimab
Dosage Form
220
Dosage
30mg, 300mg
Endpoints
Annualized asthma exacerbation rate
(AAER) during the 48-week
placebo-controlled treatment period
(blinded treatment period).
Exacerbation events are defined as
worsening of asthma requiring the use
of systemic corticosteroids
for ≥ 3 days, emergency department
visit resulting in requirement for
systemic corticosteroids for ≥ 3 days
or an inpatient hospitalization due to
asthma
(AAER) during the 48-week
placebo-controlled treatment period
(blinded treatment period).
Exacerbation events are defined as
worsening of asthma requiring the use
of systemic corticosteroids
for ≥ 3 days, emergency department
visit resulting in requirement for
systemic corticosteroids for ≥ 3 days
or an inpatient hospitalization due to
asthma
Inclution Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:
101 Subject has provided informed consent prior to initiation of any study specific
activities/procedures.
102 Subjects must be between the ages of 18 and 75 inclusive or of legal adult age
within the specific country (if different) at the time of signing the informed
consent.
103 Asthma diagnosed by a physician for 12 months prior to the screening visit.
104 Existing therapy with medium-dose to high-dose ICS (fluticasone propionate daily
or equivalent ICS) with at least 1 additional controller medication (eg, LABA,
LTRA LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg
prednisone equivalent) for at least 90 days prior to the screening visit with a
stable dose for at least 30 days prior to the screening visit.
To be classified as being on medium-dose ICS, the subjects will be on a total
daily dose (sum of all ICS) of 250 to 500 g fluticasone propionate dry
powder inhaler (DPI) equivalent.
To be classified as being on high-dose ICS, the subjects will be on a total
daily dose of 500 g fluticasone propionate DPI equivalent.
Classification of ICS doses (medium or high) will be based upon the GINA
guidelines ICS classification table (GINA, 2022), shown in Section 11.8
(Appendix 8).
105 Documented history of 1 asthma exacerbation in the past year prior to
screening, with at least 1 exacerbation during treatment with medium-dose to
high-dose ICS (refer to criterion 104).
Exacerbation events are defined as worsening of asthma requiring the use of
systemic corticosteroids for 3 days, emergency department visit resulting in
requirement for systemic corticosteroids for 3 days or an inpatient
hospitalization due to asthma.
101 Subject has provided informed consent prior to initiation of any study specific
activities/procedures.
102 Subjects must be between the ages of 18 and 75 inclusive or of legal adult age
within the specific country (if different) at the time of signing the informed
consent.
103 Asthma diagnosed by a physician for 12 months prior to the screening visit.
104 Existing therapy with medium-dose to high-dose ICS (fluticasone propionate daily
or equivalent ICS) with at least 1 additional controller medication (eg, LABA,
LTRA LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg
prednisone equivalent) for at least 90 days prior to the screening visit with a
stable dose for at least 30 days prior to the screening visit.
To be classified as being on medium-dose ICS, the subjects will be on a total
daily dose (sum of all ICS) of 250 to 500 g fluticasone propionate dry
powder inhaler (DPI) equivalent.
To be classified as being on high-dose ICS, the subjects will be on a total
daily dose of 500 g fluticasone propionate DPI equivalent.
Classification of ICS doses (medium or high) will be based upon the GINA
guidelines ICS classification table (GINA, 2022), shown in Section 11.8
(Appendix 8).
105 Documented history of 1 asthma exacerbation in the past year prior to
screening, with at least 1 exacerbation during treatment with medium-dose to
high-dose ICS (refer to criterion 104).
Exacerbation events are defined as worsening of asthma requiring the use of
systemic corticosteroids for 3 days, emergency department visit resulting in
requirement for systemic corticosteroids for 3 days or an inpatient
hospitalization due to asthma.
Exclusion Criteria
Prior/Concomitant Therapy
217 Any change in background maintenance therapy for control of asthma not
made 30 days prior to the screening visit.
218 Prior use of immunosuppressive or immunomodulatory biologic therapy within
4 months or 5 half-lives (whichever is longer) of the last administration prior to
the day 1 pre-randomization visit.
219 Systemic immunosuppressant/immunomodulators (eg, cyclosporine,
methotrexate, mycophenolate mofetil, janus kinase inhibitors, etc).
Immunosuppressants are not allowed to be used from 2 months or at least
5 half-lives prior to day 1 pre-randomization visit, whichever is longer.
220 History of bronchial thermoplasty in the past 2 years.
221 Intravenous immunoglobulin (IVIG) therapy is not allowed for 30 days prior to day
1 pre-randomization visit.
222 For subjects on maintenance asthma treatment with theophylline: theophylline
level which is not within the therapeutic range (defined as between 8 to
20 mcg/mL) at screening visit (documentation of level within 30 days of screening
visit are permitted, see Section 6.1.2.1). Exception: for subjects who are on
maintenance treatment with theophylline, where theophylline is being used in
addition to at least 2 other asthma controller medications, a theophylline level
that is lower than the therapeutic range ( 8 mcg/mL) is permissible and would
not be exclusionary if discussed and approved by the Amgen medical monitor.
217 Any change in background maintenance therapy for control of asthma not
made 30 days prior to the screening visit.
218 Prior use of immunosuppressive or immunomodulatory biologic therapy within
4 months or 5 half-lives (whichever is longer) of the last administration prior to
the day 1 pre-randomization visit.
219 Systemic immunosuppressant/immunomodulators (eg, cyclosporine,
methotrexate, mycophenolate mofetil, janus kinase inhibitors, etc).
Immunosuppressants are not allowed to be used from 2 months or at least
5 half-lives prior to day 1 pre-randomization visit, whichever is longer.
220 History of bronchial thermoplasty in the past 2 years.
221 Intravenous immunoglobulin (IVIG) therapy is not allowed for 30 days prior to day
1 pre-randomization visit.
222 For subjects on maintenance asthma treatment with theophylline: theophylline
level which is not within the therapeutic range (defined as between 8 to
20 mcg/mL) at screening visit (documentation of level within 30 days of screening
visit are permitted, see Section 6.1.2.1). Exception: for subjects who are on
maintenance treatment with theophylline, where theophylline is being used in
addition to at least 2 other asthma controller medications, a theophylline level
that is lower than the therapeutic range ( 8 mcg/mL) is permissible and would
not be exclusionary if discussed and approved by the Amgen medical monitor.
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
428 participants
