A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
- Registration Number
- NCT06376045
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 428
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-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (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 prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 μg fluticasone propionate or equivalent ICS).
- Morning pre-BD FEV1 ≥ 35% and ≤ 90% 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm B: Dose 1 Rocatinlimab Rocatinlimab Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period. Treatment Arm A: Placebo Placebo Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period. Treatment Arm C: Dose 2 Rocatinlimab Rocatinlimab Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period. Treatment Arm D: Dose 3 Rocatinlimab Rocatinlimab Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
- Primary Outcome Measures
Name Time Method Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period Up to approximately two years
- Secondary Outcome Measures
Name Time Method Annualized Rate of CompEx Events Up to approximately two years Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period Up to approximately two years Change From Baseline in Pre-BD FEV1 Up to approximately two years Change From Baseline in Asthma Symptom Diary (ASD) Score Up to approximately two years Number of Participant Achieving ACQ-6 Response at Week 48 Up to approximately two years Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score Up to approximately two years Number of Participants Achieving AQLQ (S) Response at Week 48 Up to approximately two years Time to First CompEx Event Up to approximately two years Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 Up to approximately two years Number of Participants with a CompEx Event During the Double Blinded Treatment Period Up to approximately two years Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) Up to approximately two years Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period Up to approximately two years Time to First Asthma Exacerbation Event Up to approximately two years Trough Concentration (Ctrough) of Rocatinlimab Up to approximately two years Number of Participants with Serious Adverse Events Up to approximately two years Number of Participants with Anti-rocatinlimab Antibody Formation Up to approximately two years Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels Up to approximately two years Number of Participants with Treatment-emergent Adverse Events Up to approximately two years Serum Rocatinlimab Concentrations Up to approximately two years Change From Baseline in ACQ-6 Up to approximately two years
Trial Locations
- Locations (151)
Kern Research Inc
🇺🇸Bakersfield, California, United States
Orso Health Inc
🇺🇸La Jolla, California, United States
Imax Clinical Trials
🇺🇸La Palma, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Downtown Los Angeles Research Center, Inc
🇺🇸Los Angeles, California, United States
NewportNativeMD, Inc
🇺🇸Newport Beach, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Apex Clinical Research
🇺🇸San Diego, California, United States
Allergy and Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
Allianz Research Institute Westminster
🇺🇸Westminster, California, United States
Scroll for more (141 remaining)Kern Research Inc🇺🇸Bakersfield, California, United States