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)

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Research Site 006
RECRUITING
Mobile
Arizona
Research Site 076
RECRUITING
Peoria
California
Research Site 021
RECRUITING
Huntington Beach
Research Site 082
RECRUITING
La Mesa
Research Site 031
RECRUITING
Los Angeles
Research Site 020
RECRUITING
Newport Beach
Research Site 037
RECRUITING
Rancho Cucamonga
Research Site 036
RECRUITING
San Jose
Research Site 062
RECRUITING
San Jose
Research Site 071
RECRUITING
West Covina
Colorado
Research Site 024
RECRUITING
Englewood
Florida
Research Site 001
RECRUITING
Clearwater
Research Site 026
RECRUITING
Cutler Bay
Research Site 069
RECRUITING
Deland
Research Site 025
RECRUITING
Leesburg
Research Site 003
RECRUITING
Miami
Research Site 030
RECRUITING
Miami Gardens
Research Site 041
RECRUITING
Tallahassee
Research Site 081
RECRUITING
Tamarac
Georgia
Research Site 080
RECRUITING
Cordele
Research Site 084
RECRUITING
East Point
Research Site 052
RECRUITING
Savannah
Iowa
Research Site 011
RECRUITING
Sioux City
Idaho
Research Site 065
RECRUITING
Boise
Research Site 022
RECRUITING
Meridian
Illinois
Research Site 018
RECRUITING
Winfield
Indiana
Research Site 019
RECRUITING
Merrillville
Louisiana
Research Site 005
RECRUITING
Lafayette
Massachusetts
Research Site 016
RECRUITING
Russells Mills
Maryland
Research Site 027
RECRUITING
White Marsh
Michigan
Research Site 087
RECRUITING
Dearborn
Research Site 033
RECRUITING
Farmington Hills
Research Site 086
RECRUITING
Southfield
Montana
Research Site 032
RECRUITING
Missoula
North Carolina
Research Site 004
RECRUITING
Gastonia
Research 013
RECRUITING
Winston-salem
Nevada
Research Site 014
RECRUITING
Henderson
New York
Research Site 073
RECRUITING
Queens Village
Ohio
Research Site 075
RECRUITING
Lima
Research Site 061
RECRUITING
Toledo
Oklahoma
Research Site 007
RECRUITING
Edmond
Oregon
Research Site 009
RECRUITING
Medford
Research Site 045
RECRUITING
Portland
Pennsylvania
Research Site 083
RECRUITING
Dubois
Research Site 063
RECRUITING
Philadelphia
South Carolina
Research Site 046
RECRUITING
Mauldin
Research Site 066
RECRUITING
North Charleston
Tennessee
Research Site 038
RECRUITING
Hendersonville
Research Site 028
RECRUITING
Knoxville
Texas
Research Site 017
RECRUITING
Boerne
Research Site 072
RECRUITING
Brownsville
Research Site 085
RECRUITING
Carrollton
Research Site 078
RECRUITING
Conroe
Research Site 010
RECRUITING
Dallas
Research Site 042
RECRUITING
Dallas
Research Site 064
RECRUITING
Frisco
Research Site 074
RECRUITING
Greenville
Research Site 015
RECRUITING
Houston
Research Site 010
RECRUITING
Mckinney
Virginia
Research Site 023
RECRUITING
Hampton
Contact Information
Primary
Uniquity One Clinical Trials
ClinicalTrials@uniquity.com
484-267-2500
Backup
Anushri Walsh
awalsh@devprobiopharma.com
973-983-3700
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 124
Treatments
Experimental: Solrikitug low dose subcutaneous injection
Solrikitug
Experimental: Solrikitug mid dose subcutaneous injection
Solrikitug
Experimental: Solrikitug high dose subcutaneous injection
Solrikitug
Placebo_comparator: Placebo subcutaneous injection
Placebo
Related Therapeutic Areas
Sponsors
Collaborators: DevPro Biopharma
Leads: Uniquity One (UNI)

This content was sourced from clinicaltrials.gov

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