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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
NCT06376045 |
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Date of registration:
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17/04/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
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Scientific title:
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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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Date of first enrolment:
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May 10, 2024 |
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Target sample size:
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428 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06376045 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Contacts
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Name:
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Amgen Call Center |
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Address:
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Telephone:
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866-572-6436 |
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Email:
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medinfo@amgen.com |
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Affiliation:
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Name:
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MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amgen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants must be between the ages of 18 and 75.
- Asthma diagnosed by a physician for = 12 months prior to the screening visit.
- Existing therapy with medium to high doses of inhaled corticosteroids (ICS) (defined
as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1
additional controller (eg, LABA, leukotriene receptor antagonist [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.
- Documented history of = 1 asthma exacerbation in the past year, with at least 1
exacerbation during treatment with medium to high doses of ICS (> 250 µg fluticasone
propionate or equivalent ICS).
- Morning pre-BD FEV1 = 40% and = 80% of predicted normal at the screening visit and day
1 pre-randomization visits.
- ACQ-6 score = 1.5 at the day 1 pre randomization visit.
Exclusion Criteria:
- Asthma exacerbation that results in emergency treatment or hospitalization, or
treatment with systemic steroids at any time from 30 days prior to the day 1 pre
randomization visit.
- Any clinically important pulmonary disease other than asthma.
- Current smoker, including active vaping of any products and/or marijuana, or former
smoker with cessation within 6 months of screening, or history of > 10 pack-years.
- Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the
screening period including known history of COVID-19 infection within 4 weeks prior to
Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
secondary to COVID-19 within 3 months prior to screening; participants with COVID-19
infection who have not yet sufficiently recovered to participate in the procedures of
a clinical trial.
- Active chronic or acute infection requiring treatment with systemic antibiotics,
antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely
resolved, or for which therapy has not been completed, within 4 weeks before day 1
pre-randomization visit.
- Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
- Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative
disorder; or a history of any of these conditions within 5 years prior to informed
consent
- History of major immunologic reaction to any other biologic product or any excipient
of rocatinlimab.
- Diagnosis of a helminth parasitic infection within 6 months prior to day 1
pre-randomization visit that had not been treated with or had failed to respond to
standard of care therapy.
- Evidence of human immunodeficiency virus (HIV) infection or positive for HIV
antibodies at screening or current acquired, common variable or inherited, primary or
secondary immunodeficiency.
- Active and non-virally suppressed hepatitis B infection at initial screening,
- Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV
RNA.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Placebo
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Drug: Rocatinlimab
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Primary Outcome(s)
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Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period
[Time Frame: Up to approximately two years]
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Secondary Outcome(s)
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Annualized Rate of CompEx Events
[Time Frame: Up to approximately two years]
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Number of Participant Achieving ACQ-6 Response at Week 48
[Time Frame: Up to approximately two years]
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Number of Participants Achieving AQLQ (S) Response at Week 48
[Time Frame: Up to approximately two years]
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Number of Participants with Serious Adverse Events
[Time Frame: Up to approximately two years]
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Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
[Time Frame: Up to approximately two years]
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Number of Participants with a CompEx Event During the Double Blinded Treatment Period
[Time Frame: Up to approximately two years]
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Change From Baseline in Asthma Symptom Diary (ASD) Score
[Time Frame: Up to approximately two years]
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Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
[Time Frame: Up to approximately two years]
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Serum Rocatinlimab Concentrations
[Time Frame: Up to approximately two years]
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Change From Baseline in ACQ-6
[Time Frame: Up to approximately two years]
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Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
[Time Frame: Up to approximately two years]
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Time to First Asthma Exacerbation Event
[Time Frame: Up to approximately two years]
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Time to First CompEx Event
[Time Frame: Up to approximately two years]
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Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score
[Time Frame: Up to approximately two years]
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Change From Baseline in Pre-BD FEV1
[Time Frame: Up to approximately two years]
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Number of Participants with Treatment-emergent Adverse Events
[Time Frame: Up to approximately two years]
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Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
[Time Frame: Up to approximately two years]
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Trough Concentration (Ctrough) of Rocatinlimab
[Time Frame: Up to approximately two years]
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Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
[Time Frame: Up to approximately two years]
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Number of Participants with Anti-rocatinlimab Antibody Formation
[Time Frame: Up to approximately two years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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