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A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
Phase 2 trial testing IRL201104 in Eosinophilic Esophagitis in 36 participants. Completed in 24 October 2022.
| Lead sponsor | Revolo Biotherapeutics |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 29 October 2021 |
| Primary completion | 24 October 2022 |
| Estimated completion | 24 October 2022 |
| Sites | 23 locations across United States |
Revolo Biotherapeutics — full company profile →
Adults 18 to 75, any sex, with Eosinophilic Esophagitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | -9.2 | ± 87.95 |
| Arm 2: IRL201104 8 mg | -31.6 | ± 68.09 |
| Arm 3: Placebo | -7.8 | ± 104.02 |
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
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | -15.000 | -26.923 – 0.000 |
| Arm 2: IRL201104 8 mg | -6.937 | -18.092 – 5.846 |
| Arm 3: Placebo | -3.909 | -40.923 – 5.409 |
Percent of participants with a histologic eosinophil count of \< 15 eos/hpf will be summarized for each treatment group
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 1 |
The percent change from baseline in peak intraepithelial eosinophil count in each treatment group will be summarized as the mean and SD
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 31.061 | ± 83.858 |
| Arm 2: IRL201104 8 mg | -19.007 | ± 39.716 |
| Arm 3: Placebo | 44.306 | ± 197.449 |
Number of participants who had a TEAE
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 6 | |
| Arm 2: IRL201104 8 mg | 7 | |
| Arm 3: Placebo | 7 |
Number of participants with treatment emergent clinically significant abnormal lab value.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 1 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
Number of participants with treatment emergent clinically significant abnormal lab value
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 1 | |
| Arm 3: Placebo | 0 |
Number of participants with treatment emergent clinically significant abnormal value \[Hemoglobin, Hematocrit, red blood cells count, white blood cell count, red cell indices, platelet count and white blood cell differential (neutrophil, lymphocyte, monocyte, eosinophil, and basophil)\].
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
Number of participants with treatment emergent clinically significant abnormal value (Ventricular Rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval).
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
Number of participants with treatment emergent clinically significant abnormal value \[Body Systems: head, eyes, ears, nose and throat (HEENT); cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance\].
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
Number of participants with treatment emergent clinically significant abnormal value (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature).
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: IRL201104 4 mg | 0 | |
| Arm 2: IRL201104 8 mg | 0 | |
| Arm 3: Placebo | 0 |
Time frame: From first dose to week 8. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1: IRL201104 4 mg | Arm 2: IRL201104 8 mg | Arm 3: Placebo |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Presyncope | Nervous system disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — |
| Tremor | Nervous system disorders | — | — | — |
| Chest discomfort | General disorders | — | — | — |
| Infusion site pain | General disorders | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Ear infection | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Gout | Metabolism and nutrition disorders | — | — | — |
| Hypertriglyceridemia | Metabolism and nutrition disorders | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Sleep disorder | Psychiatric disorders | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
Data from ClinicalTrials.gov NCT05084963 adverse events section.
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)
8 peer-reviewed publications reference this trial (live from Europe PMC):
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