A Study to Evaluate Solriktug in Adult Participants With Asthma

Last updated: January 30, 2026
Sponsor: Uniquity One (UNI)
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

Placebo

Biological: Solrikitug Mid 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: 140
Treatment Group(s): 6
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 26, 2024
Estimated Completion Date:
September 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 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.

Connect with a study center

  • Research Site 006

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Research Site 006

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Research Site 076

    Peoria 5308480, Arizona 5551752 85381
    United States

    Active - Recruiting

  • Research Site 021

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Research Site 031

    Los Angeles, California 90017
    United States

    Site Not Available

  • Research Site 020

    Newport Beach, California 92663
    United States

    Site Not Available

  • Research Site 037

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Research Site 021

    Huntington Beach 5358705, California 5332921 92647
    United States

    Active - Recruiting

  • Research Site 082

    La Mesa 5363990, California 5332921 91942
    United States

    Active - Recruiting

  • Research Site 031

    Los Angeles 5368361, California 5332921 90017
    United States

    Active - Recruiting

  • Research Site 020

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • Research Site 037

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Active - Recruiting

  • Research Site 036

    San Jose 5392171, California 5332921 95117
    United States

    Active - Recruiting

  • Research Site 062

    San Jose 5392171, California 5332921 95128
    United States

    Active - Recruiting

  • Research Site 071

    West Covina 5407933, California 5332921 91790
    United States

    Active - Recruiting

  • Research Site 024

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Research Site 024

    Englewood 5421250, Colorado 5417618 80110
    United States

    Active - Recruiting

  • Research Site 001

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Research Site 026

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Research Site 025

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Research Site 003

    Miami, Florida 33186
    United States

    Site Not Available

  • Research Site 030

    Miami Gardens, Florida 33014
    United States

    Site Not Available

  • Research Site 041

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Research Site 001

    Clearwater 4151316, Florida 4155751 33765
    United States

    Active - Recruiting

  • Research Site 026

    Cutler Bay 6332309, Florida 4155751 33189
    United States

    Active - Recruiting

  • Research Site 069

    DeLand 4152890, Florida 4155751 32720
    United States

    Active - Recruiting

  • Research Site 025

    Leesburg 4161771, Florida 4155751 34748
    United States

    Active - Recruiting

  • Research Site 003

    Miami 4164138, Florida 4155751 33186
    United States

    Active - Recruiting

  • Research Site 030

    Miami Gardens 4164167, Florida 4155751 33014
    United States

    Active - Recruiting

  • Research Site 041

    Tallahassee 4174715, Florida 4155751 32308
    United States

    Active - Recruiting

  • Research Site 081

    Tamarac 4174738, Florida 4155751 33321
    United States

    Active - Recruiting

  • Research Site 052

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Research Site 080

    Cordele 4189423, Georgia 4197000 31015
    United States

    Active - Recruiting

  • Research Site 084

    East Point 4192674, Georgia 4197000 30344
    United States

    Active - Recruiting

  • Research Site 052

    Savannah 4221552, Georgia 4197000 31406
    United States

    Active - Recruiting

  • Research Site 022

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Research Site 065

    Boise 5586437, Idaho 5596512 83706
    United States

    Active - Recruiting

  • Research Site 022

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Research Site 018

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Research Site 018

    Winfield 4916826, Illinois 4896861 60190
    United States

    Active - Recruiting

  • Research Site 019

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Research Site 019

    Merrillville 4923482, Indiana 4921868 46410
    United States

    Site Not Available

  • Research Site 011

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Research Site 011

    Sioux City 4876523, Iowa 4862182 51106
    United States

    Active - Recruiting

  • Research Site 005

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Research Site 005

    Lafayette 4330145, Louisiana 4331987 70508
    United States

    Active - Recruiting

  • Research Site 027

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • Research Site 027

    White Marsh 4373426, Maryland 4361885 21162
    United States

    Active - Recruiting

  • Research Site 016

    Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Research Site 016

    South Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Research Site 016

    Russells Mills 4949233, Massachusetts 6254926 02747
    United States

    Site Not Available

  • Research Site 016

    South Dartmouth 4951356, Massachusetts 6254926 02747
    United States

    Active - Recruiting

  • Research Site 033

    Farmington Hills, Michigan 48336
    United States

    Site Not Available

  • Research Site 087

    Dearborn 4990510, Michigan 5001836 48126
    United States

    Active - Recruiting

  • Research Site 033

    Farmington Hills 4992523, Michigan 5001836 48336
    United States

    Active - Recruiting

  • Research Site 086

    Southfield 5010636, Michigan 5001836 48075
    United States

    Active - Recruiting

  • Research Site 032

    Missoula, Montana 59808
    United States

    Site Not Available

  • Research Site 032

    Missoula 5666639, Montana 5667009 59808
    United States

    Active - Recruiting

  • Research Site 014

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Research Site 014

    Henderson 5505411, Nevada 5509151 89052
    United States

    Active - Recruiting

  • Research Site 073

    Queens Village 5133271, New York 5128638 11428
    United States

    Active - Recruiting

  • Research Site 004

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Research 013

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Research Site 004

    Gastonia 4467732, North Carolina 4482348 28054
    United States

    Site Not Available

  • Research 013

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Active - Recruiting

  • Research Site 013

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Active - Recruiting

  • Research Site 075

    Lima 5160783, Ohio 5165418 45801
    United States

    Active - Recruiting

  • Research Site 061

    Toledo 5174035, Ohio 5165418 43617
    United States

    Active - Recruiting

  • Research Site 007

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • Research Site 007

    Edmond 4535740, Oklahoma 4544379 73034
    United States

    Active - Recruiting

  • Research Site 009

    Medford, Oregon 97504
    United States

    Site Not Available

  • Research Site 045

    Portland, Oregon 97202
    United States

    Site Not Available

  • Research Site 009

    Medford 5740099, Oregon 5744337 97504
    United States

    Active - Recruiting

  • Research Site 045

    Portland 5746545, Oregon 5744337 97202
    United States

    Active - Recruiting

  • Research Site 083

    DuBois 5187432, Pennsylvania 6254927 15801
    United States

    Active - Recruiting

  • Research Site 063

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Active - Recruiting

  • Research Site 008

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Research Site 046

    Mauldin 4586523, South Carolina 4597040 29662
    United States

    Active - Recruiting

  • Research Site 066

    North Charleston 4589387, South Carolina 4597040 29406
    United States

    Active - Recruiting

  • Research Site 038

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Research Site 028

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Research Site 038

    Hendersonville 4628735, Tennessee 4662168 37075
    United States

    Active - Recruiting

  • Research Site 028

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Active - Recruiting

  • Research Site 017

    Boerne, Texas 78006
    United States

    Site Not Available

  • Research Site 015

    Houston, Texas 77070
    United States

    Site Not Available

  • Research Site 010

    McKinney, Texas 75071
    United States

    Site Not Available

  • Research Site 017

    Boerne 4675373, Texas 4736286 78006
    United States

    Active - Recruiting

  • Research Site 072

    Brownsville 4676740, Texas 4736286 78520
    United States

    Active - Recruiting

  • Research Site 085

    Carrollton 4679195, Texas 4736286 75010
    United States

    Active - Recruiting

  • Research Site 078

    Conroe 4682991, Texas 4736286 77384
    United States

    Active - Recruiting

  • Research Site 010

    Dallas 4684888, Texas 4736286 75254
    United States

    Active - Recruiting

  • Research Site 042

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Research Site 064

    Frisco 4692559, Texas 4736286 75035
    United States

    Active - Recruiting

  • Research Site 074

    Greenville 4695066, Texas 4736286 75401
    United States

    Active - Recruiting

  • Research Site 015

    Houston 4699066, Texas 4736286 77070
    United States

    Active - Recruiting

  • Research Site 010

    McKinney 4710178, Texas 4736286 75071
    United States

    Active - Recruiting

  • Research Site 023

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Research Site 023

    Hampton 4762894, Virginia 6254928 23666
    United States

    Active - Recruiting

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