A Study to Evaluate Solriktug in Adult Participants With Asthma

Last updated: April 25, 2025
Sponsor: Uniquity One (UNI)
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

Biological: Solrikitug Mid Dose

Biological: Solrikitug High Dose

Clinical Study ID

NCT06496607
NSI-8226-204
  • Ages 18-75
  • All Genders

Study Summary

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

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 priorto screening: inhaled corticosteroid (ICS) in combination with long-acting betaagonist (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 atScreening Visit 1.

  • Evidence of asthma as documented by reversibility in FEV1 of ≥12% and ≥200 mL overthe pre-salbutamol FEV1 at Screening Visit.

Exclusion

Key exclusion criteria:

  • Female participant who is pregnant or breastfeeding.

  • Participant is a current smoker, or former smoker with a smoking history of ≥10pack-years.

  • Participant has a known hypersensitivity to any component of the formulation ofsolrikitug, including any of the excipients, or a history of anaphylactic reactionto 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 obfuscatethe study data.

  • Participant has an exacerbation of asthma requiring use of OCS or hospitalization inthe 6 weeks prior to Screening or during the Screening Period.

  • Participant has history or evidence of any clinically significant pulmonarycondition, other than asthma.

  • Lower respiratory tract infection within the 6 weeks prior to Screening.

Study Design

Total Participants: 124
Treatment Group(s): 6
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 26, 2024
Estimated Completion Date:
April 30, 2026

Study 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 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.

Connect with a study center

  • Research Site 033

    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

    3.43 miles

  • Research Site 019

    Merrillville, Indiana 46410
    United States

    Active - Recruiting

    217.42 miles

  • Research Site 018

    Winfield, Illinois 60190
    United States

    Active - Recruiting

    251.84 miles

  • Research Site 028

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

    449.58 miles

  • Research 013

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

    468.08 miles

  • Research Site 004

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

    508.54 miles

  • Research Site 023

    Hampton, Virginia 23666
    United States

    Active - Recruiting

    520.91 miles

  • Research Site 008

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

    529.08 miles

  • Research Site 016

    South Dartmouth, Massachusetts 02747
    United States

    Site Not Available

    632.07 miles

  • Research Site 016

    Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

    632.07 miles

  • Research Site 011

    Sioux City, Iowa 51106
    United States

    Active - Recruiting

    663.24 miles

  • Research Site 006

    Mobile, Alabama 36608
    United States

    Active - Recruiting

    857.39 miles

  • Research Site 007

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

    887.47 miles

  • Research Site 025

    Leesburg, Florida 34748
    United States

    Active - Recruiting

    946.82 miles

  • Research Site 010

    McKinney, Texas 75071
    United States

    Active - Recruiting

    963.18 miles

  • Research Site 005

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

    976.2 miles

  • Research Site 001

    Clearwater, Florida 33765
    United States

    Active - Recruiting

    999.22 miles

  • Research Site 015

    Houston, Texas 77070
    United States

    Active - Recruiting

    1,096.85 miles

  • Research Site 024

    Englewood, Colorado 80110
    United States

    Active - Recruiting

    1,144.41 miles

  • Research Site 003

    Miami, Florida 33186
    United States

    Active - Recruiting

    1,170.48 miles

  • Research Site 026

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

    1,176.71 miles

  • Research Site 017

    Boerne, Texas 78006
    United States

    Active - Recruiting

    1,218.01 miles

  • Research Site 032

    Missoula, Montana 59808
    United States

    Active - Recruiting

    1,532.67 miles

  • Research Site 022

    Meridian, Idaho 83642
    United States

    Active - Recruiting

    1,663.41 miles

  • Research Site 014

    Henderson, Nevada 89052
    United States

    Active - Recruiting

    1,749.13 miles

  • Research Site 020

    Newport Beach, California 92663
    United States

    Active - Recruiting

    1,964.96 miles

  • Research Site 021

    Huntington Beach, California 92647
    United States

    Active - Recruiting

    1,965.56 miles

  • Research Site 031

    Los Angeles, California 90017
    United States

    Active - Recruiting

    1,968.03 miles

  • Research Site 009

    Medford, Oregon 97504
    United States

    Active - Recruiting

    1,997.54 miles

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