RECRUITING

A Study to Evaluate Solriktug in Adult Participants With Asthma

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Conditions

Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2024-07-26
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06496607

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be aged 18 to 75 years of age.
  2. * Documented diagnosis of asthma at least 12 months prior to Screening.
  3. * 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 \[LAMA\]).
  4. * Participant has an ACQ-6 score ≥1.5 at Screening Visit.
  5. * Participant has FEV1 of ≥50% to 90%, inclusive, of predicted normal value at Screening Visit 1.
  6. * Evidence of asthma as documented by reversibility in FEV1 of ≥12% and ≥200 mL over the pre-salbutamol FEV1 at Screening Visit.
  1. * Female participant who is pregnant or breastfeeding.
  2. * Participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years.
  3. * 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.
  4. * 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.
  5. * Participant has an exacerbation of asthma requiring use of OCS or hospitalization in the 6 weeks prior to Screening or during the Screening Period.
  6. * Participant has history or evidence of any clinically significant pulmonary condition, other than asthma.
  7. * Lower respiratory tract infection within the 6 weeks prior to Screening.

Contacts and Locations

Study Contact

Uniquity One Clinical Trials
CONTACT
484-267-2500
ClinicalTrials@uniquity.com
Anushri Walsh
CONTACT
973-983-3700
awalsh@devprobiopharma.com

Principal Investigator

Andrew W Lee, MD
STUDY_DIRECTOR
Vice President, Clinical Research

Study Locations (Sites)

Research Site 006
Mobile, Alabama, 36608
United States
Research Site 021
Huntington Beach, California, 92647
United States
Research Site 020
Newport Beach, California, 92663
United States
Research Site 024
Englewood, Colorado, 80110
United States
Research Site 001
Clearwater, Florida, 33765
United States
Research Site 025
Leesburg, Florida, 34748
United States
Research Site 003
Miami, Florida, 33186
United States
Research Site 022
Meridian, Idaho, 83642
United States
Research Site 018
Winfield, Illinois, 60190
United States
Research Site 019
Merrillville, Indiana, 46410
United States
Research Site 011
Sioux City, Iowa, 51106
United States
Research Site 005
Lafayette, Louisiana, 70508
United States
Research Site 016
South Dartmouth, Massachusetts, 02747
United States
Research Site 014
Henderson, Nevada, 89052
United States
Research Site 004
Gastonia, North Carolina, 28054
United States
Research 013
Winston-Salem, North Carolina, 27103
United States
Research Site 007
Edmond, Oklahoma, 73034
United States
Research Site 009
Medford, Oregon, 97504
United States
Research Site 008
Rock Hill, South Carolina, 29732
United States
Research Site 017
Boerne, Texas, 78006
United States
Research Site 015
Houston, Texas, 77070
United States
Research Site 010
McKinney, Texas, 75071
United States
Research Site 023
Hampton, Virginia, 23666
United States

Collaborators and Investigators

Sponsor: Uniquity One (UNI)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma