A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE

The primary objective of this Phase 2, double-blind, multicenter study is to evaluate the **safety** and **effectiveness** of daily oral administration of dexlansoprazole delayed-release capsules in pediatric subjects aged 2 to 11 years with **erosive esophagitis** (EE). Specifically, the study aims to assess the safety and effectiveness of dexlansoprazole at doses of 30 mg or 60 mg once daily for 8 weeks in the healing of EE. Additionally, the study seeks to evaluate the safety and effectiveness of dexlansoprazole at doses of 15 mg or 30 mg once daily for 16 weeks in the maintenance of healed EE. These objectives are clinically relevant as they address the therapeutic management of EE in a pediatric population, focusing on both the initial healing phase and the subsequent maintenance of remission.

The clinical trial involves a total of **41 participants** diagnosed with **Erosive Esophagitis**. The study population comprises pediatric subjects aged 2 to 11 years, inclusive, and includes both male and female participants. The trial population was selected based on a medical history of **GERD** symptoms for at least 3 months prior to screening, with reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days. Participants also demonstrated endoscopic evidence of **Erosive Esophagitis** (LA Grade A-D) based on an endoscopy performed during the screening period or within 1 week prior to signing screening informed consent and assent, as applicable. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial includes a vulnerable population, given the pediatric nature of the participants.

The clinical trial is a **randomized**, **double-blind**, controlled study designed to evaluate the safety and effectiveness of **dexlansoprazole** delayed-release capsules in pediatric subjects aged 2 to 11 years with **erosive esophagitis** (EE). The trial is structured into two main phases: an 8-week treatment phase for healing EE and a subsequent 16-week maintenance phase for maintaining healed EE. The study will involve the administration of dexlansoprazole at doses of 30 mg or 60 mg daily during the initial treatment phase, followed by 15 mg or 30 mg daily during the maintenance phase. The trial is expected to last approximately 36 weeks, with participant involvement spanning the entire duration unless early termination criteria are met.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as a medical history of gastroesophageal reflux disease (GERD) symptoms and endoscopic evidence of EE. Following successful screening, participants will enter the treatment phase, with follow-up visits scheduled to monitor safety and efficacy outcomes. The primary endpoints include the percentage of subjects achieving healing of EE by Week 8 and maintaining healed EE for 16 weeks. Secondary endpoints focus on the percentage of days without symptoms such as stomach, chest, or throat discomfort.

The end-of-study visit will conclude the trial, assessing the overall outcomes and any adverse events. Participants may be withdrawn from the study if they experience significant adverse effects, fail to adhere to the study protocol, or if the investigator deems it necessary for their safety. The trial is conducted under strict regulatory guidelines to ensure the integrity of the data and the safety of the participants.

The clinical trial involves the administration of **Dexlansoprazole Pediatric**, a medication formulated as a **capsule, prolonged release, hard**. This experimental medication is designed for oral use and is intended for pediatric subjects aged 2 to 11 years with erosive esophagitis (EE). The active substance in the medication is **dexlansoprazole**, which is of chemical origin. The trial includes three different dosing regimens of dexlansoprazole, each with specific dosage and treatment duration parameters.

The first dosing regimen involves the administration of dexlansoprazole at a maximum daily dose of 16 mg, with a total maximum dose of 1680 mg over a treatment period of 16 weeks. This regimen is designed to assess the maintenance of healed EE in pediatric subjects. The medication is administered once daily (QD) to ensure prolonged therapeutic effects.

The second dosing regimen includes a maximum daily dose of 60 mg, with a total maximum dose of 6720 mg over a 24-week treatment period. This regimen is intended to evaluate the safety and effectiveness of dexlansoprazole in the healing of EE. The administration is also once daily, allowing for consistent plasma levels of the active substance.

The third dosing regimen involves a maximum daily dose of 30 mg, with a total maximum dose of 3360 mg over a 24-week treatment period. Similar to the other regimens, this is administered once daily and aims to maintain the healing of EE in the pediatric population. Compliance with the dosing schedule is monitored throughout the trial to ensure adherence and evaluate the therapeutic outcomes effectively.

All formulations of dexlansoprazole used in this trial are pediatric-specific and are not classified as orphan drugs. The trial does not include any non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments. The study is conducted under the sponsorship of Takeda Development Center Americas, Inc., ensuring adherence to regulatory standards and clinical trial protocols.

The efficacy of the clinical trial will be assessed through both primary and secondary endpoints. The primary endpoints include the percentage of subjects with healing of **Erosive Esophagitis (EE)** by Week 8, as determined by endoscopy, and the percentage of subjects who maintained healed EE for 16 weeks among those who were healed by Week 8, also assessed by endoscopy. Secondary endpoints focus on the percentage of days without symptoms such as hurting or burning in the stomach, chest, or throat over the first 8 weeks of treatment, and from Weeks 8 to 24 or Weeks 12 to 28 among subjects who were healed by Week 8.

The trial involves the administration of dexlansoprazole in pediatric subjects aged 2 to 11 years, with doses of 30 or 60 mg for the initial 8 weeks and 15 or 30 mg for the maintenance phase over 16 weeks. Efficacy assessments will be conducted using endoscopic evaluations at specified timepoints to determine the healing and maintenance of healed EE. Patient-reported outcomes regarding symptom relief will be collected through an electronic diary (eDiary) to track the frequency of symptoms over the designated periods. The data collected will be analyzed to evaluate the effectiveness of the treatment regimen in achieving and maintaining the healing of EE in the pediatric population.