A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis

NCT05084963 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RVLO 121-04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 23

Brief Summary

The purpose of this study is to asses the efficacy, safety and tolerability of repeat doses of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean)

  The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)

  4 weeks

Secondary Outcomes (11)

• Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline.

  4 weeks

• Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)

  4 weeks

• Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)

  4 weeks

• Treatment Emergent Adverse Events (TEAE)

  8 weeks

• Safety Laboratory Data: Biochemistry

  8 weeks

Study Arms (3)

Arm 1: IRL201104 Dose A

EXPERIMENTAL

IRL201104 IV on Days 0, 7, and 14

Drug: IRL201104

Arm 2: IRL201104 Dose B

EXPERIMENTAL

IRL201104 IV on Days 0, 7, and 14

Drug: IRL201104

Arm 3: Placebo

PLACEBO COMPARATOR

Placebo IV on Days 0, 7, and 14

Drug: Placebo

Interventions

IRL201104 DRUG

lyophilised powder for reconstitution for IV dosing

Arm 1: IRL201104 Dose A; Arm 2: IRL201104 Dose B

Placebo DRUG

Matching placebo for IRL201104

Arm 3: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old, inclusive, at the time of signing the informed consent form.
• Documented diagnosis of EoE by endoscopy prior to screening. Note: Must include a demonstration of intraepithelial eosinophilic infiltration (peak cell count ≥ 15 eos/hpf \[400×\]) from esophageal biopsy specimens from endoscopy.
• History (by participant report) of on average at least 2 episodes of dysphagia (with intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to screening, and on average at least 2 episodes of documented dysphagia per week during any 2 consecutive weeks (qualifying period) between screening and baseline; dysphagia is defined as trouble swallowing solid food, or having solid food stick, by participant report; and completed the DSQ on ≥ 70% of days during the qualifying period prior to baseline (Visit 1).
• Must remain on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups.
• Must be willing and able to continue any dietary therapy and/or medical regimens (including gastric acid suppression) in effect at the screening visit. There should be no change to these regimens during the study participation.
• Willing and able to comply with all clinic visits and study-related procedures.
• Able to understand and complete study-related questionnaires.
• Provide signed informed consent.
• Esophagogastroduodenoscopy (EGD) with photographs performed at screening (qualifying EGD), with a demonstration of intraepithelial eosinophilic infiltration (peak cell count ≥15 eos/hpf) in at least 2 of the 3 biopsied esophageal regions (proximal, mid, or distal).

You may not qualify if:

• Prior participation in an IRL201104 clinical study.
• Has any current disease of the gastrointestinal tract (aside from EoE) that may impact, in the investigator's opinion, the patient's EoE disease status. This includes, but not limited to: eosinophilic gastritis, eosinophilic enteritis, eosinophilic duodenitis, eosinophilic colitis, or proctitis; inflammatory bowel disease; or celiac disease.
• Has other causes of esophageal eosinophilia or the following diseases: hypereosinophilic syndromes, Churg-Strauss vasculitis (eosinophilic granulomatosis with polyangiitis), or peripheral blood absolute eosinophil count of \> 1500 eosinophils/μL.
• Has presence of oral or esophageal mucosal infection of any type.
• Has any condition affecting the esophageal mucosa or altering esophageal motility other than EoE.
• History of achalasia, active Helicobacter pylori infection, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery (with the exception of a surgical repair of an EoE complication).
• Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to 10 mm) upper endoscope or any critical esophageal stricture that requires dilation at screening; or dilation within 2 months prior to screening.
• On a pure liquid diet or any mouth or dental condition that prevents normal eating.
• Has initiated, discontinued, or changed dosage regimen of PPIs within the 4 weeks prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or anticipates changes in the use of PPI during the study. PPI must remain constant throughout the study.
• History of bleeding disorders or esophageal varices.
• Use of anticoagulants within 2 weeks prior to screening. Participants should not stop these agents solely to become eligible for entry into this study.
• Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening.
• Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 6 weeks prior to screening.
• Treatment with oral immunotherapy (OIT) within 6 months prior to screening.
• Allergen immunotherapy (sublingual immunotherapy \[SLIT\] and/or subcutaneous immunotherapy \[SCIT\]), unless on a stable dose for at least 1 year prior to screening.

Sponsors & Collaborators

• Revolo Biotherapeutics: lead

Study Sites (23)

Revolo Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Revolo Investigational Site

Murrieta, California, 92563, United States

Location

Revolo Investigational Site

Centennial, Colorado, 80112, United States

Location

Revolo Investigational Site

New Port Richey, Florida, 34653, United States

Location

Revolo Investigational Site

Orlando, Florida, 32825, United States

Location

Revolo Investigational Site

Sandy Springs, Georgia, 30328, United States

Location

Revolo Investigational Site

Iowa City, Iowa, 52242, United States

Location

Revolo Investigational Site

Crowley, Louisiana, 70526, United States

Location

Revolo Investigational Site

Marrero, Louisiana, 70072, United States

Location

Revolo Investigational Site

Boston, Massachusetts, 02111, United States

Location

Revolo Investigational Site

Boston, Massachusetts, 02114, United States

Location

Revolo Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Revolo Investigational Site

Great Neck, New York, 11021, United States

Location

Revolo Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Revolo Investigational Site

Durham, North Carolina, 27710, United States

Location

Revolo Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Revolo Investigational Site

Mentor, Ohio, 44060, United States

Location

Revolo Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

Revolo Investigational Site

Kingsport, Tennessee, 37663, United States

Location

Revolo Investigational Site

Baytown, Texas, 77521, United States

Location

Revolo Investigational Site

Harlingen, Texas, 78550, United States

Location

Revolo Investigational Site

Riverton, Utah, 84065, United States

Location

Revolo Investigational Site

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

IRL201104

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Revolo Biotherapeutics

clinicaltrials@revolobio.com

(888) 599-7431

Study Officials

• Michael Weinreich, MD, PhD

  Senior Director, Revolo Biotherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 20, 2021
• Study Start: October 29, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

US (23)