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Monoclonal Antibodies

Solrikitug for COPD (ZION 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
* At least 40 years of age and no older than 70 years.
* Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 12 to week 28

Summary

"This trial is testing a new drug called Solrikitug in patients with Chronic Obstructive Pulmonary Disease (COPD) to see how safe and effective it is at different doses compared to

Who is the study for?
This trial is for adults aged 40-70 with COPD who experience symptoms (CAT Score ≥10), have been diagnosed for at least a year, and are on two or more inhaled meds. They must have certain levels of lung function and blood eosinophils as per GOLD Guidelines.
What is being tested?
The study tests Solrikitug's safety and effects in different doses compared to a placebo in people with COPD. It's randomized, meaning participants are put into groups by chance, double-blind so neither they nor the researchers know who gets what treatment until after the study.
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include irritation at injection sites, allergic responses, respiratory issues due to biological nature of Solrikitug, fatigue or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 70 years old.
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I have symptoms of COPD with a CAT score of 10 or more.
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I have been on 2 or more inhaled meds for COPD for at least 3 months.
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I have been diagnosed with COPD for over a year and have high blood eosinophil levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 12 to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 12 to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in blood eosinophil counts
Secondary study objectives
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo
Group II: Biological: Solrikitug Low DoseExperimental Treatment1 Intervention
Solrikitug
Group III: Biological: Solrikitug High DoseExperimental Treatment1 Intervention
Solrikitug

Find a Location

Who is running the clinical trial?

Uniquity One (UNI)Lead Sponsor
3 Previous Clinical Trials
289 Total Patients Enrolled
DevPro BiopharmaUNKNOWN
4 Previous Clinical Trials
603 Total Patients Enrolled
Andrew W Lee, MDStudy DirectorVice President, Clinical Research
3 Previous Clinical Trials
289 Total Patients Enrolled
~84 spots leftby Apr 2025
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