Eosinophilic EsophagitisPhase 2NCT05084963
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
A Phase 2 study testing IRL201104 in people with Eosinophilic Esophagitis, run by Revolo Biotherapeutics at 23 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- IRL201104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 23 sitesUnited States
- Study dates
- 29 Oct 2021to 24 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
- The following treatments within 3 months before the screening visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the study:
- Systemic immunosuppressive/immunomodulating drugs (eg, omalizumab, cyclosporine, mycophenolate-mofetil, interferon [IFN]γ, Janus kinase inhibitors, azathioprine, methotrexate, and other biologics that are ongoing [eg, dupilumab, benralizumab, mepolizumab, or vedolizumab]).
- Diagnosed with active parasitic infection; or suspected parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
- Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
- Known or suspected immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, non-tuberculous mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immunocompromised status, as judged by the investigator.
- Known history of human immunodeficiency virus (HIV) infection.
- Positive or indeterminate hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening.
- Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m2) or end stage renal disease.
- Elevated transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) > 3 times the upper limit of normal (ULN) at screening.
- History of malignancy within 5 years prior to screening, except completely treated in situ carcinoma of the cervix and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
- Any other medical or psychological condition including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in this clinical study, may make the participant's participation unreliable, or may interfere with study assessments. The specific justification for participants excluded under this criterion will be noted in study documents (eg, chart notes, electronic case report form). These may include participant-reported alcohol or drug abuse and severe concomitant illness(es).
- Planned or anticipated use of any prohibited medications and procedures (as described in the exclusion criteria) during study treatment.
- Treatment with a live (attenuated) vaccine within 3 months prior to screening and/or treatment of a killed vaccine within 30 days prior to screening, until the end of the study with the exception of a coronavirus disease of 2019 (COVID-19) vaccine, as described in Section 9.2.1.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 30 days after the last dose of study treatment. These include: hormonal contraceptives, intrauterine device, or double barrier contraception (ie, condom and diaphragm), or male partner with documented vasectomy.
- For females, menopause is defined as at least 12 consecutive months without menses; to include laboratory confirmation of post-menopausal status (ie, a follicle stimulating hormone (FSH) of 2.25 U/mL must be documented). Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Revolo Investigational Site
Baytown, Texas, 77521
Revolo Investigational Site
Boston, Massachusetts, 02111
Revolo Investigational Site
Boston, Massachusetts, 02114
Revolo Investigational Site
Centennial, Colorado, 80112
Revolo Investigational Site
Chapel Hill, North Carolina, 27599
Revolo Investigational Site
Chattanooga, Tennessee, 37421
Revolo Investigational Site
Crowley, Louisiana, 70526
Revolo Investigational Site
Durham, North Carolina, 27710
Revolo Investigational Site
Farmington Hills, Michigan, 48334
Revolo Investigational Site
Great Neck, New York, 11021
Revolo Investigational Site
Harlingen, Texas, 78550
Revolo Investigational Site
Iowa City, Iowa, 52242
Revolo Investigational Site
Kingsport, Tennessee, 37663
Revolo Investigational Site
Little Rock, Arkansas, 72211
Revolo Investigational Site
Marrero, Louisiana, 70072
Revolo Investigational Site
Mentor, Ohio, 44060
Revolo Investigational Site
Murrieta, California, 92563
Revolo Investigational Site
New Port Richey, Florida, 34653
Revolo Investigational Site
Orlando, Florida, 32825
Revolo Investigational Site
Raleigh, North Carolina, 27607
Revolo Investigational Site
Riverton, Utah, 84065
Revolo Investigational Site
Salt Lake City, Utah, 84132
Revolo Investigational Site
Sandy Springs, Georgia, 30328
About this study
Official title: A Phase 2a, Double-blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of IRL201104 in Adult Participants With Active Eosinophilic Esophagitis (EoE)
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
- Being tested
- IRL201104, Placebo
- Keywords
- EoE
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRL201104Drug
lyophilised powder for reconstitution for IV dosing
PlaceboDrug
Matching placebo for IRL201104
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: IRL201104 Dose A | Experimental | IRL201104 IV on Days 0, 7, and 14 Receives: Drug: IRL201104 |
| Arm 2: IRL201104 Dose B | Experimental | IRL201104 IV on Days 0, 7, and 14 Receives: Drug: IRL201104 |
| Arm 3: Placebo | Placebo comparator | Placebo IV on Days 0, 7, and 14 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (11)
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. The change from baseline in DSQ score in each treatment group will be summarized as the median, minimum, and maximum
Measured: 4 weeks
Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)
Percent of participants with a histologic eosinophil count of < 15 eos/hpf will be summarized for each treatment group
Measured: 4 weeks
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)
The percent change from baseline in peak intraepithelial eosinophil count in each treatment group will be summarized as the mean and SD
Measured: 4 weeks
Treatment Emergent Adverse Events (TEAE)
Number of participants who had a TEAE
Measured: 8 weeks
Safety Laboratory Data: Biochemistry
Number of participants with treatment emergent clinically significant abnormal lab value.
Measured: 8 weeks
Safety Laboratory Data: Coagulation
Number of participants with treatment emergent clinically significant abnormal lab value
Measured: 8 weeks
Safety Laboratory Data: Hematology Panel
Number of participants with treatment emergent clinically significant abnormal value [Hemoglobin, Hematocrit, red blood cells count, white blood cell count, red cell indices, platelet count and white blood cell differential (neutrophil, lymphocyte, monocyte, eosinophil, and basophil)].
Measured: 8 weeks
Safety Laboratory Data: Urinalysis Panel
Number of participants with treatment emergent clinically significant abnormal value (Color, Glucose, Red blood cells, Clarity, Blood, Hyaline and other casts, pH, Bilirubin, Bacteria, Specific gravity, Leukocyte esterase, Epithelial cells, Ketones, Nitrite, Crystals, Protein, White blood cells, Yeast).
Measured: 8 weeks
12-Lead ECG
Number of participants with treatment emergent clinically significant abnormal value (Ventricular Rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval).
Measured: 8 weeks
Physical Exam
Number of participants with treatment emergent clinically significant abnormal value [Body Systems: head, eyes, ears, nose and throat (HEENT); cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance].
Measured: 8 weeks
Vital Signs
Number of participants with treatment emergent clinically significant abnormal value (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start29 Oct 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revolo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Weinreich, MD, PhD, Study director, Senior Director, Revolo Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084963
- Sponsor's protocol ID
- RVLO 121-04
- Status last verified
- May 2025
- First submitted
- 30 Sep 2021
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double-blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of IRL201104 in Adult Participants With Active Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT05084963
- Acronym / sponsor ID
- RVLO 121-04
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EoE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Revolo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: IRL201104 Dose A | Experimental | Drug: IRL201104IRL201104 IV on Days 0, 7, and 14 |
| Arm 2: IRL201104 Dose B | Experimental | Drug: IRL201104IRL201104 IV on Days 0, 7, and 14 |
| Arm 3: Placebo | Placebo comparator | Drug: PlaceboPlacebo IV on Days 0, 7, and 14 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRL201104lyophilised powder for reconstitution for IV dosing | Drug | Arm 1: IRL201104 Dose A, Arm 2: IRL201104 Dose B |
| PlaceboMatching placebo for IRL201104 | Drug | Arm 3: Placebo |
Primary outcome
Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean)
Time frame: 4 weeks
The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)
11 secondary outcomes
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline.
Time frame: 4 weeks
Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)
Time frame: 4 weeks
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)
Time frame: 4 weeks
Treatment Emergent Adverse Events (TEAE)
Time frame: 8 weeks
Safety Laboratory Data: Biochemistry
Time frame: 8 weeks
Safety Laboratory Data: Coagulation
Time frame: 8 weeks
Safety Laboratory Data: Hematology Panel
Time frame: 8 weeks
Safety Laboratory Data: Urinalysis Panel
Time frame: 8 weeks
12-Lead ECG
Time frame: 8 weeks
Physical Exam
Time frame: 8 weeks
Vital Signs
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Weinreich, MD, PhD study director
Senior Director, Revolo Biotherapeutics
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRL201104 in people with Eosinophilic Esophagitis, run by Revolo Biotherapeutics at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.