Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (NCT06109441) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
United States50 participantsStarted 2023-12-04
Plain-language summary
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase and a LTE (Long Term Extension)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult participants 18 to 75 years old, inclusive, at Screening.
✓. Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments.
✓. Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report.
✓. Moderately to severely active UC, at the time of Screening, defined as a modified Mayo Score (mMS) of 5-9, inclusive, with an endoscopic subscore of ≥ 2 (from central reading), and a rectal bleeding (RB) subscore of ≥ 1.
✓. Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon.
✓. Stable doses of concomitant medications:
✓. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 20 mg/day (prednisone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until the end of the Induction Phase.
✓. Subjects receiving oral 5-aminosalicylic acid (5-ASA) must be on a stable dose from the initial Screening visit until the end of study.
Exclusion criteria
✕. Diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC), or radiation-induced colitis.
✕. Ulcerative colitis limited to the rectum (ulcerative proctitis).