Asthma
Conditions
Brief summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Detailed description
This is a 12-week randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with asthma. Approximately 140 adult participants with asthma will be randomized. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.
Interventions
BIOLOGICALNSI-8226
Solrikitug
BIOLOGICALPlacebo
Placebo
Sponsors
Uniquity One (UNI)
DevPro Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo | Over weeks 8 and 12 | Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of multiple doses of solrikitug | To week 12 | Adverse events (AEs) and serious adverse events (SAEs) |
Countries
United States
Contacts
STUDY_DIRECTORAndrew W Lee, MD
Vice President, Clinical Research
Outcome results
None listed