A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Amgen

Status and phase: Enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Rocatinlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06376045

20220093

Details and patient eligibility

About

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Enrollment: 428 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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428 participants in 4 patient groups, including a placebo group

Treatment Arm A: Placebo

Placebo Comparator group

Description:

Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.

Treatment:

Drug: Placebo

Treatment Arm B: Dose 1 Rocatinlimab

Experimental group

Description:

Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.

Treatment:

Drug: Rocatinlimab

Treatment Arm C: Dose 2 Rocatinlimab

Experimental group

Description:

Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.

Treatment:

Drug: Rocatinlimab

Treatment Arm D: Dose 3 Rocatinlimab

Experimental group

Description:

Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.

Treatment:

Drug: Rocatinlimab