Phase 2a, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of ALTB-268 in Subjects With Moderately to Severely Active Ulcerative Colitis Refractory to Biologic Therapy
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, a Maintenance Phase, and an OLE.
• 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.
‣ Subjects receiving immunosuppressants (azathioprine, 6-mercaptopurine \[6-MP\] or methotrexate) must be on a stable dose for 4 weeks prior to Screening until the end of study treatment. Subjects taking methotrexate are also advised to take folic acid 5 mg/week (or equivalent) if there is no contraindication.
‣ Subjects receiving probiotics must be on a stable dose from the initial Screening visit until the end of study.
‣ Subjects receiving an anti-diarrhetic must be on a stable dose for ≥ 2 weeks prior to Screening until the end of study.
• Previous treatment with one or two advanced therapy that demonstrated an inadequate response and/or loss of response.
• Negative pregnancy test during Screening and Day 1 (V0) in females of childbearing potential.
• Females with reproductive potential must be sexually abstinent or be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. Highly effective methods of contraception include:
∙ Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); male partner should use a condom;
‣ Intrauterine device or system; or
‣ Surgical sterilization or partner sterile (must have documented proof).
⁃ Male subjects must be either surgically sterile (must have documented proof), agree to be sexually abstinent, or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration to ≥ 3 months after the final dose administration.
⁃ Male subjects must agree to refrain from donating sperm from first study drug administration to ≥ 3 months after final dose administration.