A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).

JRCT ID: jRCT2021230017

Registered date:25/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Eosinophilic Esophagitis
• Date of first enrollment: 18/10/2023
• Target sample size: 360
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Slovakia,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United Sates,Japan
• Study type: Interventional
• Intervention(s): In the 52-week double-blind placebo-controlled treatment period, participants will be randomized 1:1:1 to receive either 210 mg Q4W tezepelumab, 420 mg Q4W tezepelumab, or placebo administered by SC injections. After completion of the double-blind placebo-controlled treatment period, participants will have the option to enter the optional active treatment extension period for 24 weeks. For those participants randomized to receive placebo during the double-blind placebocontrolled treatment period who choose to enter the optional active treatment extension period, they will be re-randomized to either 420 mg or 210 mg of tezepelumab in a 1:1 ratio. Participants who have been randomized to an active tezepelumab arm during the double-blind placebo-controlled treatment period will remain on the same tezepelumab dose.

Outcome(s)

Primary Outcome

- Histologic response of peak esophageal eosinophil per HPF count of 6 or less across all available esophageal levels [Time Frame: Week 24]
_The peak esophageal eosinophil count is based on 2-4 esophageal biopsies from 2-3 locations..

- Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score [Time Frame: Week 24]
_The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.

2. Weight 40 kg or more at Visit 1.

3.Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.

4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1.

5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 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).

6. May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period.

7. Participants currently on leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).

8. If a medication for EoE (for example PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer.

9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.

Exclude criteria

1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.

2. Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.

3. Use of a feeding tube, or having a pattern of not eating solid food >3 days of week. Solid food is defined as food that requires chewing before swallowing.

4. Hypereosinophilic syndrome.

5. EGPA vasculitis.

6. Esophageal dilation performed within 8 weeks prior to screening.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05583227