A Study to Evaluate Solriktug in Adult Participants With Asthma
NCT ID: NCT06496607
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2024-07-26
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
NCT02334553
A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
NCT06598462
Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
NCT07245368
Study In Asthma Control
NCT00273026
SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
NCT00238784
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Approximately 124 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Solrikitug low dose subcutaneous injection
Solrikitug
NSI-8226
Solrikitug
Solrikitug mid dose subcutaneous injection
Solrikitug
NSI-8226
Solrikitug
Solrikitug high dose subcutaneous injection
Solrikitug
NSI-8226
Solrikitug
Placebo subcutaneous injection
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NSI-8226
Solrikitug
NSI-8226
Solrikitug
NSI-8226
Solrikitug
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DevPro Biopharma
INDUSTRY
Uniquity One (UNI)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew W Lee, MD
Role: STUDY_DIRECTOR
Vice President, Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site 006
Mobile, Alabama, United States
Research Site 076
Peoria, Arizona, United States
Research Site 021
Huntington Beach, California, United States
Research Site 082
La Mesa, California, United States
Research Site 031
Los Angeles, California, United States
Research Site 020
Newport Beach, California, United States
Research Site 037
Rancho Cucamonga, California, United States
Research Site 036
San Jose, California, United States
Research Site 062
San Jose, California, United States
Research Site 071
West Covina, California, United States
Research Site 024
Englewood, Colorado, United States
Research Site 001
Clearwater, Florida, United States
Research Site 026
Cutler Bay, Florida, United States
Research Site 069
DeLand, Florida, United States
Research Site 025
Leesburg, Florida, United States
Research Site 003
Miami, Florida, United States
Research Site 030
Miami Gardens, Florida, United States
Research Site 041
Tallahassee, Florida, United States
Research Site 081
Tamarac, Florida, United States
Research Site 080
Cordele, Georgia, United States
Research Site 084
East Point, Georgia, United States
Research Site 052
Savannah, Georgia, United States
Research Site 065
Boise, Idaho, United States
Research Site 022
Meridian, Idaho, United States
Research Site 018
Winfield, Illinois, United States
Research Site 019
Merrillville, Indiana, United States
Research Site 011
Sioux City, Iowa, United States
Research Site 005
Lafayette, Louisiana, United States
Research Site 027
White Marsh, Maryland, United States
Research Site 016
Russells Mills, Massachusetts, United States
Research Site 087
Dearborn, Michigan, United States
Research Site 033
Farmington Hills, Michigan, United States
Research Site 086
Southfield, Michigan, United States
Research Site 032
Missoula, Montana, United States
Research Site 014
Henderson, Nevada, United States
Research Site 073
Queens Village, New York, United States
Research Site 004
Gastonia, North Carolina, United States
Research 013
Winston-Salem, North Carolina, United States
Research Site 075
Lima, Ohio, United States
Research Site 061
Toledo, Ohio, United States
Research Site 007
Edmond, Oklahoma, United States
Research Site 009
Medford, Oregon, United States
Research Site 045
Portland, Oregon, United States
Research Site 083
DuBois, Pennsylvania, United States
Research Site 063
Philadelphia, Pennsylvania, United States
Research Site 046
Mauldin, South Carolina, United States
Research Site 066
North Charleston, South Carolina, United States
Research Site 038
Hendersonville, Tennessee, United States
Research Site 028
Knoxville, Tennessee, United States
Research Site 017
Boerne, Texas, United States
Research Site 072
Brownsville, Texas, United States
Research Site 085
Carrollton, Texas, United States
Research Site 078
Conroe, Texas, United States
Research Site 042
Dallas, Texas, United States
Research Site 010
Dallas, Texas, United States
Research Site 064
Frisco, Texas, United States
Research Site 074
Greenville, Texas, United States
Research Site 015
Houston, Texas, United States
Research Site 010
McKinney, Texas, United States
Research Site 023
Hampton, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Resarch Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NSI-8226-204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.