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Assessing Rocatinlimab for 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

Phase 2 Interventional Amgen · NCT06376045

This study is testing a new treatment called rocatinlimab to see if it can help adults with moderate-to-severe asthma have fewer asthma attacks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment428 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsrocatinlimab, prednisone
Locations150 sites (Bakersfield, California and 149 other locations)
Trial IDNCT06376045 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of rocatinlimab, a new treatment, in reducing asthma exacerbations in adults with moderate-to-severe asthma. Participants aged 18 to 75 who have been diagnosed with asthma for at least a year and are currently on medium to high doses of inhaled corticosteroids will be enrolled. The study will compare the effects of rocatinlimab against a placebo to determine its effectiveness in managing asthma symptoms. Participants must have a documented history of asthma exacerbations and meet specific lung function criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a history of moderate-to-severe asthma and recent exacerbations despite current treatment.

Not a fit: Patients with mild asthma or those not currently on medium to high doses of inhaled corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce asthma exacerbations and improve the quality of life for patients with moderate-to-severe asthma.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for asthma, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bakersfield, California and 149 other locations

+100 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaModerate to severe asthmaRocatinlimabAMG 451KHK4083
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.