A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
Purpose
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
Condition
- Asthma
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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, 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 ≥ 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Treatment Arm A: Placebo |
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period. |
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|
Experimental Treatment Arm B: Dose 1 Rocatinlimab |
Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period. |
|
|
Experimental Treatment Arm C: Dose 2 Rocatinlimab |
Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period. |
|
|
Experimental Treatment Arm D: Dose 3 Rocatinlimab |
Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period. |
|
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555-0158
Galveston, Texas 77555-0158
More Details
- Status
- Recruiting
- Sponsor
- Amgen