E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eosinophilic Esophagitis (EoE) |
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E.1.1.1 | Medical condition in easily understood language |
Eosinophilic esophagitis (EoE) a chronic, allergic inflammatory disease of the esophagus (the tube connecting the mouth to the stomach). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064220 |
E.1.2 | Term | Eosinophilic esophagitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effects of etrasimod on esophageal eosinophilia in adult subjects with active EoE To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active EoE To select an etrasimod dose based on efficacy and safety for continued development |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of etrasimod on dysphagia symptoms in adult subjects with active EoE |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key Inclusion Criteria (Full Inclusion Criteria Are Provided in the Protocol) • Men or women between 18 and 65 years of age at the time of informed consent (IC) • Have and EoE diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils (eos)/high power field (hpf) (~60 eos/mm2) from any level (proximal, mid, or distal) of the esophagus at the Screening esophagogastroduodenoscopy (EGD). • Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks (as documented using the Dysphagia Symptom Questionnaire (DSQ) during the Screening period) |
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E.4 | Principal exclusion criteria |
Key Exclusion Criteria (Full Exclusion Criteria Are Provided in the Protocol) • History of any of the following non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic, endoscopic, or symptom endpoints of the study: a. Conditions that substantially contribute to esophageal eosinophilia (eg, eosinophilic gastritis or enteritis [ie, eosinophilic duodenitis or colitis] with esophageal involvement, achalasia , hypereosinophilic syndrome, Crohn’s disease [CD] with esophageal involvement, esophageal infection [fungal, viral], eosinophilic granulomatosis with polyangiitis (formally known as Churg-Strauss Syndrome), pemphigus, with esophageal involvement, pill esophagitis, graft versus host disease, Mendelian disorders [eg, Marfan syndrome Type II, hyper-immunoglobulin E (IgE) syndrome, phosphatase and tensin homolog (PTEN) hamartoma tumor syndrome, Netherton syndrome, severe atopy metabolic wasting (SAM) syndrome]) b. Conditions that interfere with the evaluation of the esophagus (eg, esophageal varices with risk of spontaneous bleed, high-grade esophageal stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of Screening EGD) c. Conditions or procedures that substantially contribute to dysphagia (eg, histologically active Barrett’s esophagitis, active erosive esophagitis Los Angeles Grade B or above, significant hiatal hernia [≥ 4 cm], esophageal resection) • Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD. • Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD. • Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Subjects on any of the following therapy need to stay on a stable regimen during study participation: a. Elemental diet b. EoE food trigger elimination diet c. PPI therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change from Baseline in esophageal PEC at Week 16 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Absolute change from Baseline in DSQ score at Week 16 • Absolute change from Baseline in esophageal PEC at Week 16 • Proportion of subjects with esophageal PEC < 15 eos/hpf at Week 16 • Proportion of subjects with esophageal PEC ≤ 6 eos/hpf at Week 16 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
United States |
Netherlands |
Spain |
Switzerland |
Germany |
Belgium |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |