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Monoclonal Antibodies

Rocatinlimab for Asthma

Phase 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between the ages of 18 and 75.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately two years
Awards & highlights

Summary

"This trial aims to see how well rocatinlimab can help reduce asthma attacks."

Who is the study for?
This trial is for adults aged 18-75 with moderate-to-severe asthma, diagnosed over a year ago. They must have had at least one asthma attack in the past year despite using medium to high doses of inhalers and other controllers. Their lung function and symptom scores will be checked to see if they fit.Check my eligibility
What is being tested?
The study tests Rocatinlimab's ability to reduce asthma attacks compared to a placebo. Participants are randomly assigned either the drug or placebo alongside their usual asthma treatments, to see which works better.See study design
What are the potential side effects?
While specific side effects for Rocatinlimab aren't listed here, common ones for new asthma drugs can include sore throat, headache, allergic reactions, and worsening of breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I've been on a strong asthma treatment with steroids and another controller for over 3 months.
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My lung function is between 40% and 80% of the expected level.
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I've had at least one asthma attack in the last year while on a medium to high dose of inhaler.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period
Secondary outcome measures
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
Annualized Rate of CompEx Events
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
+17 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm D: Dose 3 RocatinlimabExperimental Treatment1 Intervention
Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
Group II: Treatment Arm C: Dose 2 RocatinlimabExperimental Treatment1 Intervention
Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.
Group III: Treatment Arm B: Dose 1 RocatinlimabExperimental Treatment1 Intervention
Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.
Group IV: Treatment Arm A: PlaceboPlacebo Group1 Intervention
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rocatinlimab
2024
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,692 Total Patients Enrolled
23 Trials studying Asthma
6,109 Patients Enrolled for Asthma
MDStudy DirectorAmgen
937 Previous Clinical Trials
926,839 Total Patients Enrolled
9 Trials studying Asthma
1,558 Patients Enrolled for Asthma
~285 spots leftby Aug 2026