A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma (NCT06376045) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
United States317 participantsStarted 2024-05-24
Plain-language summary
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
What they're measuring
1
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period