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Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245840
Recruitment Status : Active, not recruiting
First Posted : August 10, 2017
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Brief Summary:
This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis (EoE) Drug: Budesonide oral suspension Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide Oral Suspension
Participants will be initiated on 10 milliliter (mL) of Budesonide oral suspension (0.2 milligram/mL) twice daily up to 72 months (Visit 12) or early termination (ET).
Drug: Budesonide oral suspension
Budesonide oral suspension (BOS) 10 mL twice daily




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration to 3 days after last study drug administration (up to Month 73) ]
    Treatment-emergent adverse event is defined as an adverse event (AE) that starts or deteriorates on or after the date of the first dose of BOS and no later than 3 days following the last dose of investigational product.

  2. Number of Participants With Clinically Relevant Changes in Physical Examinations, Vital Signs and Clinical Laboratory Assessments [ Time Frame: From start of study drug administration to 3 days after last study drug administration (up to Month 73) ]
    A change in the value of a clinical laboratory or vital sign assessment can represent an AE if the change is clinically relevant.

  3. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 2 (Month 12) [ Time Frame: Baseline and Visit 2 (Month 12) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  4. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 4 (Month 24) [ Time Frame: Baseline and Visit 4 (Month 24) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  5. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 6 (Month 36) [ Time Frame: Baseline and Visit 6 (Month 36) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  6. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 8 (Month 48) [ Time Frame: Baseline and Visit 8 (up to Month 48) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  7. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 10 (Month 60) [ Time Frame: Baseline and Visit 10 (up to Month 60) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  8. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 12 (Month 72) [ Time Frame: Baseline and Visit 12 (up to Month 72) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  9. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 2 (Month 12) [ Time Frame: Baseline and Visit 2 (Month 12) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]).

  10. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 4 (Month 24) [ Time Frame: Baseline and Visit 4 (Month 24) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  11. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 6 (Month 36) [ Time Frame: Baseline and Visit 6 (Month 36) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  12. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 8 (Month 48) [ Time Frame: Baseline and Visit 8 (up to Month 48) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  13. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 10 (Month 60) [ Time Frame: Baseline and Visit 10 (up to Month 60) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  14. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 12 (Month 72) [ Time Frame: Baseline and Visit 12 (up to Month 72) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant completed the SHP621-302 (NCT02736409) extension study and is considered by the investigator to potentially benefit from continued BOS investigational treatment.
  • Participant is able to provide written informed consent (participant, parent or legal guardian and, as appropriate, participant assent) to participate in the study before completing any study-related procedures.
  • Females of childbearing potential must agree to continue acceptable birth control measures (example (e.g.): abstinence, surgically sterile male partner, stable oral contraceptives, or double-barrier methods) throughout study participation.
  • Participant is willing and has an understanding and ability to fully comply with study procedures and restrictions as defined in protocol.

Exclusion Criteria:

  • Participant has changes in medications or diet during the SHP621-302 (NCT02736409) study that could affect participation in this continuation study.
  • Participant anticipates using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition during the treatment period; any temporary use (less than or equal to [≤] 7 days) or initiation of new steroid treatment during the study should be documented and discussed with the medical monitor prospectively but should be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs).
  • Participant anticipates use of Cytochrome P450 3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during the continuation study.
  • Participant has an appearance at the EGD at the final treatment evaluation visit of SHP621-302 (NCT02736409) (Visit 8) of an esophageal stricture (high grade), as defined by the presence of a lesion that does not allow passage of a diagnostic adult upper endoscope (e.g., with an insertion tube diameter of greater than (>) 9 millimeter [mm]).
  • Participant has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
  • Participant has any current disease of the gastrointestinal tract, aside from EoE, including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel disease, or celiac disease.
  • Participant has other diseases causing or associated with esophageal eosinophilia, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection.
  • Participant has oropharyngeal or esophageal candidiasis that failed to respond to previous treatment. Diagnosis with oropharyngeal or esophageal candidiasis at or since the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study is not an exclusion as long as the participant is expected to respond to treatment.
  • Participant has a potentially serious acute or chronic infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or chicken pox/measles.
  • Participant has upper gastrointestinal bleeding identified at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
  • Participant has evidence of active infection with Helicobacter pylori.
  • Participant has evidence of unstable asthma.
  • Participant is female and pregnant or nursing.
  • Participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction to budesonide (or any other corticosteroids), or to any other ingredients of the study medication.
  • Participant has a history or high risk of noncompliance with treatment or regular clinic visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245840


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03245840    
Other Study ID Numbers: SHP621-303
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists