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Monoclonal Antibodies

Solriktug for Asthma (RAINIER Trial)

Phase 2
Recruiting
Research Sponsored by Uniquity One (UNI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of asthma as documented by reversibility in FEV1 of ≥12% and ≥200 mL over the pre-salbutamol FEV1 at Screening Visit
Participant must be aged 18 to 75 years of age
Must not have
Participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years
Participant has history or evidence of any clinically significant pulmonary condition, other than asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over weeks 8 and 12

Summary

"This trial is testing a new medication called solriktug in adults with asthma to see if it is safe, well-tolerated, and how the body processes it. Researchers will also study how

Who is the study for?
Adults with asthma are eligible for this trial. Specific details about who can join or reasons why someone might not be able to participate (inclusion and exclusion criteria) were not provided.
What is being tested?
The study is testing three different doses of a biological drug called Solriktug against a placebo to assess its safety, how the body processes it, immune response, and effects on asthma.
What are the potential side effects?
Potential side effects of Solriktug aren't detailed here but may include typical reactions to biological treatments such as injection site reactions, allergic responses, or respiratory symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My asthma improves significantly after using a bronchodilator.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently smoke or have smoked at least 10 pack-years.
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I have a significant lung condition other than asthma.
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I am currently pregnant or breastfeeding.
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I am allergic to solrikitug or similar medications.
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I've needed steroids or hospital care for my asthma recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over weeks 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and over weeks 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Secondary study objectives
To assess the safety and tolerability of multiple doses of solrikitug

Trial Design

4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo
Group II: Biological: Solrikitug Mid DoseExperimental Treatment1 Intervention
Solrikitug
Group III: Biological: Solrikitug Low DoseExperimental Treatment1 Intervention
Solrikitug
Group IV: Biological: Solrikitug High DoseExperimental Treatment1 Intervention
Solrikitug

Find a Location

Who is running the clinical trial?

DevPro BiopharmaUNKNOWN
4 Previous Clinical Trials
654 Total Patients Enrolled
Uniquity One (UNI)Lead Sponsor
3 Previous Clinical Trials
340 Total Patients Enrolled
Andrew W Lee, MDStudy DirectorVice President, Clinical Research
3 Previous Clinical Trials
340 Total Patients Enrolled
~47 spots leftby Apr 2025
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