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Evaluating solriktug for asthma in adults

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)

Phase 2 Interventional Uniquity One (UNI) · NCT06496607

This study is testing a new asthma treatment called solriktug to see if it’s safe and effective for adults when added to their usual care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorUniquity One (UNI) Industry-sponsored
Locations28 sites (Mobile, Alabama and 27 other locations)
Trial IDNCT06496607 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of solriktug in adult participants with asthma. The study will involve approximately 124 adults who will be randomly assigned to receive either solriktug or a placebo via subcutaneous injection over a 12-week period, alongside their standard asthma care. Participants will be monitored for their response to the treatment and will undergo a follow-up period of 16 weeks after the treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a documented diagnosis of asthma and currently on maintenance asthma medications.

Not a fit: Patients who are pregnant, breastfeeding, current smokers, or have a significant smoking history may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for adults suffering from asthma.

How similar studies have performed: Other studies evaluating similar biologic treatments for asthma have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Mobile, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.