Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GB004, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:
1. prednisone ≤ 20 mg/day or equivalent or
2. beclomethasone ≤ 5 mg/day or
3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day
You may not be if
Prior approved biologic therapy used for the treatment of UC.
Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
Azathioprine, or 6-mercaptopurine within 1 day of Day 1.
Clareo Health | A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
