Treatment of Moderate to Severe Refractory Crohn's Disease
Trial Parameters
Brief Summary
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
Eligibility Criteria
Inclusion Criteria: 1. Male and females ≥ 18 and ≤ 65 years of age at time of consent. 2. Weight of ≥ 40 kg. 3. Medical history and biological evidence of active bowel inflammation documented by: * Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and; * Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader) 4. Active disease defined as moderate to severe active CD at Screening defined by all of the following: * Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and; * CDAI total scores ≥ 220 5. Subject on treatment with corticosteroids may be included if they meet the following: * prednisone or equivalent dose ≤ 20 mg/day; or * budesonide ≤ 9 mg/day; or * has been on a stable dose for at least 7 days prior to TRX103 dose. 6. Advanced therapy-refractory disease defined by: Failure of two or m