Condition: Asthma · Sponsor: Uniquity One (UNI)
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Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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 requiring use of OCS or hospitalization in the 6 weeks prior to Screening or during the Screening Period. * Participant has history or evidence of any clinically significant pulmonary condition, other than asthma. * Lower respiratory tract infection within the 6 weeks prior to Screening.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Velocity Clinical Research | Mobile, Alabama, United States | — |
| Phoenix Medical Group | Peoria, Arizona, United States | — |
| Warren W. Pleskow, M.D. | Encinitas, California, United States | — |
| Beach Physicians Clinical Research Corp. | Huntington Beach, California, United States | — |
| Biosolutions Clinical Research Center | La Mesa, California, United States | — |
| Orso Health | Long Beach, California, United States | — |
| Downtown LA Research Center | Los Angeles, California, United States | — |
| Newport Native MD, Inc. | Newport Beach, California, United States | — |
| Prospective Research Innovations Inc. | Rancho Cucamonga, California, United States | — |
| Allergy & Asthma Medical Group and Research Center | San Diego, California, United States | — |
| Allergy & Asthma Associates of Santa Clara Valley | San Jose, California, United States | — |
| San Jose Clinical Trials | San Jose, California, United States | — |
+ 57 more locations — full list on the registry record.
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