Efficacy and Safety Study of MAX-002 Suppository Versus Placebo in Mild to Moderate Ulcerative Proctitis

• The responder rate at Week 3 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
• Rectal bleeding at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Total Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 6 (health economics evaluation) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Time to relief of tenesmus [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

• Responder rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
• Rectal bleeding [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Total IBDQ score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Tenesmus [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Hypothesis: The responder rate of the MAX-002 will be superior to placebo after 6 weeks of treatment in patients with mild to moderate ulcerative proctitis.

Summary: The primary purpose of this study is to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis.

Prior to randomization, all inclusion and exclusion criteria will be verified to confirm eligibility. Patients found to be eligible will be randomized in a 1:1:1 scheme to receive either MAX-002 1 g, Canasa® 1 g, or Placebo suppository once daily at bedtime for 6 weeks in a double-blind fashion. Completers at Study Week 6 will be offered to receive MAX-002 1 g suppositories on a voluntary basis during the next 8 weeks of the open-label phase. Regardless of the treatment groups, all patients will be evaluated through phone calls at Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6, and 14. Study-specific procedures include but are not limited to the following: flexible proctosigmoidoscopy; disease activity assessment; smoking habits description; health-related quality of life; compliance to treatment check and safety evaluations (physical examinations, ECG, vitals signs, clinical laboratory analyses). All patients will complete daily diaries and will be asked general open questions about any occurrence of adverse events/concurrent medical conditions, use of adjunctive therapy/procedure, and their intake of concomitant medication.

• Drug: MAX-002
  MAX-002 1 g suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase. Completers at Study Week 6 will be offered to receive, on a voluntary basis, MAX-002 1 g suppositories once daily at bedtime for 8 weeks during the open-label phase.
• Drug: Placebo
  Placebo suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase.
• Drug: Canasa®
  Canasa® 1 g suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase.

• Experimental: MAX-002 suppositories
  Intervention: Drug: MAX-002
• Placebo Comparator: Placebo suppositories
  Intervention: Drug: Placebo
• Active Comparator: Canasa® suppositories
  Intervention: Drug: Canasa®

Main Inclusion Criteria:

• At screening, patients must have confirmation of mild to moderate UP not extending above the rectum with a total Mayo DAI score between 5 and 10, inclusively.
• Score of 2 or more for the "Rectal bleeding" and for the "Findings of flexible proctosigmoidoscopy or colonoscopy" sub-scores of the Mayo DAI.

Main Exclusion Criteria:

• Presence of other digestive diseases interfering with the measurement of any sub-score of the DAI.
• Known presence or suspicion of malignant disease of the digestive system or presence or history of neoplasms other than carcinoma in situ of the cervix or basal carcinoma of the skin.
• Chronic use of oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4 g daily, change in the oral 5-ASA dosing, or use of any form of rectal 5-ASA formulations during the 30 days prior to randomization.
• Significant use of corticosteroids that may have a therapeutic effect on UP, immunosuppressants or biologic response modifiers during the 45 days prior to the date of consent.
• Use of any rectally administered medicine during the 30 days prior to randomization.
• Presence of other known clinically significant medical and/or psychological illnesses precluding participation.