A Study to Evaluate Solriktug in Adult Participants With Asthma

Phase 2

Recruiting

• Conditions: Asthma

• Registration Number: NCT06496607
• Lead Sponsor: Uniquity One (UNI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Inclusion Criteria:<br><br> - Participant must be aged 18 to 75 years of age.<br><br> - Documented diagnosis of asthma at least 12 months prior to Screening.<br><br> - Participants must be on maintenance asthma medications, for at least 3 months prior<br> to screening: inhaled corticosteroid (ICS) in combination with long-acting beta<br> agonist (LABA), or as part of an approved triple therapy for asthma<br> (ICS/LABA/long-acting muscarinic antagonist [LAMA]).<br><br> - Participant has an ACQ-6 score =1.5 at Screening Visit.<br><br> - Participant has FEV1 of =50% to 90%, inclusive, of predicted normal value at<br> Screening Visit 1.<br><br> - Evidence of asthma as documented by reversibility in FEV1 of =12% and =200 mL over<br> the pre-salbutamol FEV1 at Screening Visit.<br><br>Exclusion Criteria:<br><br> - Female participant who is pregnant or breastfeeding.<br><br> - Participant is a current smoker, or former smoker with a smoking history of =10<br> pack-years.<br><br> - Participant has a known hypersensitivity to any component of the formulation of<br> solrikitug, including any of the excipients, or a history of anaphylactic reaction<br> to any therapeutic monoclonal antibody.<br><br> - Participant has history or evidence of any clinically significant cardiovascular,<br> hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic,<br> psychiatric, renal and/or other major disease or malignancy, or any other condition<br> (risks factors of pneumonia) that in the opinion of the Investigator might obfuscate<br> the study data.<br><br> - Participant has an exacerbation of asthma requiring use of OCS or hospitalization in<br> the 6 weeks prior to Screening or during the Screening Period.<br><br> - Participant has history or evidence of any clinically significant pulmonary<br> condition, other than asthma.<br><br> - Lower respiratory tract infection within the 6 weeks prior to Screening.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple doses of solrikitug