Clinical trial NCT06496607: A Study to Evaluate Solriktug in Adult Participants With Asthma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Uniquity One (UNI)
Sponsor class: INDUSTRY
Collaborators: name: DevPro Biopharma
First posted: 2024-07-11
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 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.

Key exclusion criteria:

* 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.

Primary outcomes:
measure: To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
timeFrame: Over weeks 8 and 12
Secondary outcomes:
measure: To assess the safety and tolerability of multiple doses of solrikitug
timeFrame: To week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site 006
state: Alabama
city: Huntington Beach
country: United States
facility: Research Site 021
state: California
city: Los Angeles
country: United States
facility: Research Site 031
state: California
city: Newport Beach
country: United States
facility: Research Site 020
state: California
city: Englewood
country: United States
facility: Research Site 024
state: Colorado
city: Clearwater
country: United States
facility: Research Site 001
state: Florida
city: Cutler Bay
country: United States
facility: Research Site 026
state: Florida
city: Leesburg
country: United States
facility: Research Site 025
state: Florida
city: Miami
country: United States
facility: Research Site 003
state: Florida
city: Meridian
country: United States
facility: Research Site 022
state: Idaho
city: Winfield
country: United States
facility: Research Site 018
state: Illinois
city: Merrillville
country: United States
facility: Research Site 019
state: Indiana
city: Sioux City
country: United States
facility: Research Site 011
state: Iowa
city: Lafayette
country: United States
facility: Research Site 005
state: Louisiana
city: Dartmouth
country: United States
facility: Research Site 016
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site 033
state: Michigan
city: Missoula
country: United States
facility: Research Site 032
state: Montana
city: Henderson
country: United States
facility: Research Site 014
state: Nevada
city: Gastonia
country: United States
facility: Research Site 004
state: North Carolina
city: Winston-Salem
country: United States
facility: Research 013
state: North Carolina
city: Edmond
country: United States
facility: Research Site 007
state: Oklahoma
city: Medford
country: United States
facility: Research Site 009
state: Oregon
city: Rock Hill
country: United States
facility: Research Site 008
state: South Carolina
city: Knoxville
country: United States
facility: Research Site 028
state: Tennessee
city: Boerne
country: United States
facility: Research Site 017
state: Texas
city: Houston
country: United States
facility: Research Site 015
state: Texas
city: McKinney
country: United States
facility: Research Site 010
state: Texas
city: Hampton
country: United States
facility: Research Site 023
state: Virginia
Study officials:
affiliation: Vice President, Clinical Research
name: Andrew W Lee, MD
role: STUDY_DIRECTOR
References: