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IRL201104 for Eosinophilic Esophagitis

Phase 2
Waitlist Available
Research Sponsored by Revolo Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

This trial is testing a medication called IRL201104 to see if it can help adults with Active Eosinophilic Esophagitis. The condition causes inflammation in the esophagus, making it hard to swallow. The medication aims to reduce this inflammation by lowering the number of certain white blood cells.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks 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 the peak esophageal intraepithelial eosinophil count at Week 4.
Secondary study objectives
Absolute change in Dysphagia Symptom Questionnaire (DSQ) score from baseline. The DSQ is used to measure the frequency and intensity of dysphagia. The DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia
Proportion of participants achieving peak esophageal intraepithelial eosinophil count of < 15 eos/hpf
Safety Laboratory Data: Biochemistry
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2: IRL201104 Dose BExperimental Treatment1 Intervention
IRL201104 IV on Days 0, 7, and 14
Group II: Arm 1: IRL201104 Dose AExperimental Treatment1 Intervention
IRL201104 IV on Days 0, 7, and 14
Group III: Arm 3: PlaceboPlacebo Group1 Intervention
Placebo IV on Days 0, 7, and 14
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IRL201104
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Revolo BiotherapeuticsLead Sponsor
3 Previous Clinical Trials
105 Total Patients Enrolled
Jeff Myers, MD, PhDStudy DirectorChief Medical Officer, Revolo Biotherapeutics
1 Previous Clinical Trials
63 Total Patients Enrolled
Michael Weinreich, MD, PhDStudy DirectorSenior Director, Revolo Biotherapeutics
1 Previous Clinical Trials
63 Total Patients Enrolled
~9 spots leftby Nov 2025
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