A Study to Evaluate Solriktug in Adult Participants With Asthma (RAINIER)

Uniquity One (UNI)

Status and phase: Enrolling; Phase 2

Conditions: Asthma

Treatments: Biological: NSI-8226; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06496607

NSI-8226-204

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 4 patient groups, including a placebo group

Solrikitug low dose subcutaneous injection

Experimental group

Description:

Solrikitug

Treatment:

Biological: NSI-8226

Biological: NSI-8226

Biological: NSI-8226

Solrikitug mid dose subcutaneous injection

Experimental group

Description:

Solrikitug

Treatment:

Biological: NSI-8226

Biological: NSI-8226

Biological: NSI-8226

Solrikitug high dose subcutaneous injection

Experimental group

Description:

Solrikitug

Treatment:

Biological: NSI-8226

Biological: NSI-8226

Biological: NSI-8226

Placebo subcutaneous injection

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo