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Monoclonal Antibodies

Solrikitug for Eosinophilic Esophagitis

Phase 2
Waitlist Available
Research Sponsored by Uniquity One (UNI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming diagnosis of EoE
Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia per week in the 4 weeks prior to Screening
Must not have
Female participant who is pregnant or breastfeeding
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

"This trial will test the safety and effectiveness of solrikitug in adults with Eosinophilic Esophagitis."

Who is the study for?
This trial is for adults with Eosinophilic Esophagitis, a condition where eosinophils build up in the esophagus causing inflammation and difficulty swallowing. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.
What is being tested?
The study tests different doses of Solrikitug against a placebo to see if it's safe and effective for treating Eosinophilic Esophagitis. It will also look at how the body processes the drug (pharmacokinetics) and its effects on the immune system (immunogenicity).
What are the potential side effects?
While specific side effects aren't detailed, common ones may include reactions at injection sites, gastrointestinal issues, potential allergic responses or other immune-related symptoms due to medication or placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with EoE through a biopsy.
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I have had trouble swallowing at least twice a week in the last month.
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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 am currently pregnant or breastfeeding.
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I am allergic to solrikitug or similar medications.
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I had an esophageal dilation procedure within the last 8 weeks.
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I haven't had an endoscopy before starting my current treatment.
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I have a narrow esophagus that makes it hard for standard medical scopes to pass.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Solrikitug mid doseExperimental Treatment1 Intervention
Solrikitug
Group II: Solrikitug low doseExperimental Treatment1 Intervention
Solrikitug
Group III: Solrikitug high doseExperimental Treatment1 Intervention
Solrikitug
Group IV: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Uniquity One (UNI)Lead Sponsor
3 Previous Clinical Trials
267 Total Patients Enrolled
Andrew W Lee, MDStudy ChairVice President, Clinical Research
3 Previous Clinical Trials
267 Total Patients Enrolled
~105 spots leftby Apr 2027
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