A Study to Evaluate Solriktug in Adult Participants With Asthma

Description

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

Conditions

Asthma

Study Overview

Study Details

Study overview

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

A Phase 2a, 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)

A Study to Evaluate Solriktug in Adult Participants With Asthma

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Mobile

Research Site 006, Mobile, Alabama, United States, 36608

Huntington Beach

Research Site 021, Huntington Beach, California, United States, 92647

Newport Beach

Research Site 020, Newport Beach, California, United States, 92663

Englewood

Research Site 024, Englewood, Colorado, United States, 80110

Clearwater

Research Site 001, Clearwater, Florida, United States, 33765

Leesburg

Research Site 025, Leesburg, Florida, United States, 34748

Miami

Research Site 003, Miami, Florida, United States, 33186

Meridian

Research Site 022, Meridian, Idaho, United States, 83642

Winfield

Research Site 018, Winfield, Illinois, United States, 60190

Merrillville

Research Site 019, Merrillville, Indiana, United States, 46410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Uniquity One (UNI),

Andrew W Lee, MD, STUDY_DIRECTOR, Vice President, Clinical Research

Study Record Dates

2025-08-31