Budesonide for Eosinophilic Esophagitis

(EOS-4 Trial)

Recruiting at 12 trial locations

Overseen By Sarah Burrack, Dr.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dr. Falk Pharma GmbH

Disqualifiers: GERD, Achalasia, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

308 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Research Team

Alfredo J Lucendo, MD, PhD

Principal Investigator

Department of Gastroenterology, Hospital General de Tomelloso, Spain

Eligibility Criteria

Adults aged 18-75 with a confirmed diagnosis of eosinophilic esophagitis (EoE), who are currently experiencing symptoms and have histological evidence of the disease. Participants must provide informed consent and women able to bear children need a negative pregnancy test.

Inclusion Criteria

I have signed the consent form.

I am not pregnant.

I have been diagnosed with eosinophilic esophagitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1 mg budesonide orodispersible tablets twice daily or 2 mg once daily for 6 weeks to induce clinico-pathological remission

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Budesonide

Trial Overview The trial is testing if taking budesonide orodispersible tablets once daily (2 mg) is just as effective as taking them twice daily (1 mg each time) for inducing remission in EoE over six weeks.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Budesonide 2 mg orodispersible tablet once daily

Group II: Arm B Active Control 1 Intervention

Budesonide 1 mg orodispersible tablet twice daily

Who Is Running the Clinical Trial?

Dr. Falk Pharma GmbH

Lead Sponsor

Trials

46

Recruited

9,400+