Status:
WITHDRAWN
Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis
Lead Sponsor:
ReveraGen BioPharma, Inc.
Conditions:
Pediatric Ulcerative Colitis
Eligibility:
All Genders
4-17 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I/II, multi-center, open-label proof-of-concept study of vamorolone. Twenty participants with a flare of mild or moderately active Ulcerative Colitis (defined as a Pediatric Ulcerative...
Eligibility Criteria
Inclusion
- Subject has provided written informed consent/Health Insurance Portability and Accountability Act (HIPAA) authorization prior to any study-related procedures;
- Subject has current mild to moderately active ulcerative colitis, defined as a PUCAI score of 10-60.
- Subject is ≥ 4 years old and \<18 years old at the time of enrollment.
- Subject has had 1) a colonoscopy demonstrating endoscopic and histologic inflammation, and/or; 2) a fecal calprotectin \> 250 mcg/g, in the preceding 1 month.
- Subject is willing and able to comply with scheduled visits, study drug administration plan, and study procedures.
- Subject has not started a new immunomodulator or biologic in the preceding 2 months.
- If subject is taking an immunomodulator and/or biologic, the dose has not been changed in the last 2 months
- Subject has a positive varicella IgG titer, or history of at least 2 documented varicella vaccines
Exclusion
- Subject is currently being treated or has received previous treatment with oral or rectal glucocorticoids (including budesonide) in the past month
- Subject has an allergy or hypersensitivity to the study medication or to any of its constituents
- Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator
- Subject is taking any other investigational drug currently or has taken any other investigational drug within 3 months prior to the start of study treatment
- Clinically significant abnormal biochemical and hematological parameters, including:
- Neutrophil count \< 1000 cells/mm3
- Platelet count ≤ 130 cells/mm3
- Creatinine ≥ 1.2 x the upper limit of normal
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal
- Conjugated bilirubin greater than 1.2. mg/dL
- Has active infection with enteric pathogens (including C. difficile)
- Has a positive PPD, Quantiferon Gold, or Interferon-gamma assay
- Is pregnant or breast-feeding
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04348890
Start Date
September 1 2020
End Date
September 1 2022
Last Update
September 29 2020
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