The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Detailed Description
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This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day [BID] for 2 weeks and once daily [QD] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Official Title
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A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis

Conditions
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Proctitis, Proctosigmoiditis

Intervention / Treatment
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* Drug: Budesonide Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-breast-feeding females ≥18 years old. Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study. Willingness to undergo sigmoidoscopy. Exclusion Criteria: Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease). History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology. Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle. Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle. Participant took diuretics with cardiac glycosides. Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide Foam<br>Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle. | Drug: Budesonide Foam<br>* Topical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event | A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through up to Cycle 8 (Cycle=6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Notable Laboratory Parameters | Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline and Cycle 4 (Cycle=6 weeks) | 
| Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels | Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported. | Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks) | 
| Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline | A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through up to Cycle 8 (Cycle=6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-label, Proctitis, Proctosigmoiditis, Ulcerative, Salix, Budesonide foam, Budesonide, Rectal, Gastrointestinal, Colitis, UC, UP, UPS, Additional relevant MeSH terms:, Proctocolitis, Ulcer, Colitis, Ulcerative, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Rectal Diseases, Intestinal Diseases, Colonic Diseases, Sigmoid Diseases, Pathologic Processes, Inflammatory Bowel Diseases, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Pharmacologic Actions, Anti-Asthmatic Agents, Respiratory System Agents, Therapeutic Uses, Glucocorticoids, Hormones, Hormones, Hormone Substitutes and Hormone Antagonists, Anti-inflammatory Agents