A Study to Evaluate Solriktug in Adult Participants With Asthma (RAINIER)

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Adult Participants With Asthma (RAINIER)

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Biological: Placebo; Biological: NSI-8226

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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Group
  • California
    • Encinitas, California, United States, 92024
      • Warren W. Pleskow, M.D.
    • Huntington Beach, California, United States, 92647
      • Beach Physicians Clinical Research Corp.
    • La Mesa, California, United States, 91942
      • BioSolutions Clinical Research Center
    • Long Beach, California, United States, 90808
      • Orso Health
    • Los Angeles, California, United States, 90017
      • Downtown LA Research Center
    • Newport Beach, California, United States, 92663
      • Newport Native Md, Inc.
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations Inc.
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley
    • San Jose, California, United States, 95128
      • San Jose Clinical Trials
    • Santa Rosa, California, United States, 95405
      • North Bay Clinical Research
    • West Covina, California, United States, 91790
      • Providere Research
  • Colorado
    • Englewood, Colorado, United States, 80110
      • Velocity Clinical Research - Denver
  • Florida
    • Cutler Bay, Florida, United States, 33189
      • JY Research Institute
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research, LLC
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners LLC dba-Leesburg
    • Miami, Florida, United States, 33186
      • Coral Research Clinic Corp.
    • Miami, Florida, United States, 33126
      • Pharmax Research of South Florida
    • Miami Gardens, Florida, United States, 33014
      • Pro-Care Research Center, Corp.
    • Tallahassee, Florida, United States, 32308
      • Ogden Clinical Canyon View
    • Tamarac, Florida, United States, 33321
      • TBC Research
    • Tamarac, Florida, United States, 33321
      • Care Access, Tamarac
  • Georgia
    • Cordele, Georgia, United States, 31015
      • National Clinical Trials
    • East Point, Georgia, United States, 30344
      • CPCC - Research, LLC
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah, Inc.
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
    • Boise, Idaho, United States, 83706
      • Nexgen Research
  • Illinois
    • Winfield, Illinois, United States, 60190
      • Accellacare - Duly
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research - Sioux City
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Massachusetts
    • South Dartmouth, Massachusetts, United States, 02747
      • Mayflower Clinical
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Deerborn Clinic
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Farmington Hills, Michigan, United States, 48336
      • Pulmonary Research Institute of SE Michigan
    • Southfield, Michigan, United States, 48075
      • Revive Research Institute, Inc.
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Henderson Trials
  • New York
    • Queens Village, New York, United States, 11428
      • A1 Clinical
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Clinical Research
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research Inc.
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA
    • Lancaster, Pennsylvania, United States, 17601
      • Allergy & Asthma Diagnostic Treatment Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University - Shenoy
  • South Carolina
    • Mauldin, South Carolina, United States, 29662
      • Care Access - Mauldin
    • Myrtle Beach, South Carolina, United States, 29588
      • Allergy, Asthma & Sinus Center, LLC
    • North Charleston, South Carolina, United States, 29406
      • MBR - Charleston
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • Premier Research Center, LLC
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS Research
    • Brownsville, Texas, United States, 78520
      • Proactive RGV
    • Carrollton, Texas, United States, 75010
      • Ten20 Clinical Research, LLC
    • Conroe, Texas, United States, 77384
      • Javarra Research
    • Dallas, Texas, United States, 75231
      • Dallas Allergy and Asthma Center
    • Dallas, Texas, United States, 75254
      • IntraCare Health Center
    • Frisco, Texas, United States, 75035
      • US Allergy & Asthma
    • Greenville, Texas, United States, 75401
      • IntraCare Clinical
    • Houston, Texas, United States, 77070
      • Gulf Coast Clinical Research
    • Houston, Texas, United States, 77002
      • Axsendo Clinical Research
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Velocity Clinical Research - Hampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solrikitug low dose subcutaneous injection; Solrikitug	Biological: NSI-8226; Solrikitug
Experimental: Solrikitug mid dose subcutaneous injection; Solrikitug	Biological: NSI-8226; Solrikitug
Experimental: Solrikitug high dose subcutaneous injection; Solrikitug	Biological: NSI-8226; Solrikitug
Placebo Comparator: Placebo subcutaneous injection; Placebo	Biological: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo	Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12	Over weeks 8 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of multiple doses of solrikitug	Adverse events (AEs) and serious adverse events (SAEs)	To week 12

Collaborators and Investigators

• Sponsor: Uniquity One (UNI)
• Collaborators: DevPro Biopharma
• Investigators: Study Director: Andrew W Lee, MD, Vice President, Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: NSI-8226-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No