Status:
RECRUITING
A Study to Evaluate Solriktug in Adult Participants With Asthma
Lead Sponsor:
Uniquity One (UNI)
Collaborating Sponsors:
DevPro Biopharma
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 vers...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06496607
Start Date
July 26 2024
End Date
April 30 2026
Last Update
November 24 2025
Active Locations (60)
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1
Research Site 006
Mobile, Alabama, United States, 36608
2
Research Site 076
Peoria, Arizona, United States, 85381
3
Research Site 021
Huntington Beach, California, United States, 92647
4
Research Site 082
La Mesa, California, United States, 91942