Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

Inclusion Criteria: * 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 Criteria: * 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