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A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT06376045•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

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-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.
+2 more criteria

Locations (154)

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

Key Dates

Start Date

May 24, 2024

Primary Completion Date

October 19, 2026

Completion Date

December 11, 2026

Last Updated

December 11, 2025

Enrollment

317

ACTUAL participants

Conditions

Asthma

Interventions

Rocatinlimab

DRUG

Placebo

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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