A Study to Evaluate Solriktug in Adult Participants With Asthma (NCT06496607) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate Solriktug in Adult Participants With Asthma
United States145 participantsStarted 2024-07-26
Plain-language summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key inclusion criteria:
* Participant must be aged 18 to 75 years of age.
* Documented diagnosis of asthma at least 12 months prior to Screening.
* Participants must be on maintenance asthma medications, for at least 3 months prior to screening: inhaled corticosteroid (ICS) in combination with long-acting beta agonist (LABA), or as part of an approved triple therapy for asthma (ICS/LABA/long-acting muscarinic antagonist \[LAMA\]).
* Participant has an ACQ-6 score ≥1.5 at Screening Visit.
* Participant has FEV1 of ≥50% to 90%, inclusive, of predicted normal value at Screening Visit 1.
* Evidence of asthma as documented by reversibility in FEV1 of ≥12% and ≥200 mL over the pre-salbutamol FEV1 at Screening Visit.
Key exclusion criteria:
* Female participant who is pregnant or breastfeeding.
* Participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years.
* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
* Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition (risks factors of pneumonia) that in the opinion of the Investigator might obfuscate the study data.
* Participant has an exacerbation of asthma requ…
What they're measuring
1
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo