Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Condition: Proctitis, Ulcerative
MeSH terms: Proctitis; Ulcer
Intervention: MAX-002; Placebo; Canasa®
Intervention description: MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.; Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.; Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ulcerative proctitis; Proctocolitis; Inflammatory Bowel Disease; Gastrointestinal Diseases; Colonic Diseases; Mesalamine; 5-ASA

Summary:

      This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group
      comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories
      (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults
      with mild to moderate ulcerative proctitis (UP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are 18 years old or older

          -  Participants with total Mayo DAI score between 5 to 10 at Screening and participants
             with score of 2 or more for the rectal bleeding and for the findings of flexible
             proctosigmoidoscopy or colonoscopy sub-scores of the Mayo DAI

          -  Participants with confirmed mild to moderate active UP not extending above rectum as
             evidenced by flexible proctosigmoidoscopy and histopathology assessments

          -  Female participants of child-bearing age who have negative serum beta-human chorionic
             gonadotropin (β-HCG) at the time of entry into the study

          -  Female participants of child-bearing age who use medically acceptable form of birth
             control

          -  Participants who are smokers and non-smokers must not change their smoking habits or
             nicotine use during the DB treatment period

          -  Participants who are literate and have legal ability to sign informed consent form

        Exclusion Criteria:

          -  Participants with other digestive diseases interfering with the measurement of any
             sub-score of the Mayo DAI

          -  Participants with 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

          -  Participants with clinically significant electrocardiographic abnormalities that would
             compromise its participation in the study

          -  Participants who are chronically using oral 5-aminosalicylic acid (5-ASA) at a dose
             greater than 4g 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

          -  Participants with significant use of corticosteroids ,immunosuppressant's or biologic
             response modifiers that may have a therapeutic effect on ulcerative proctitis during
             the 45 days before the date of consent

          -  Participants who use any rectally administered medicine during the 30 days prior to
             randomization

          -  Participants who have contraindication to the use of mesalamine or suppository
             vehicle, analgesia, flexible proctosigmoidoscopy or colonoscopy

          -  Participants who have blood parameters of grade 3 or higher on the common terminology
             criteria for adverse events (CTCAE) 5-point scale

          -  Participants with severe renal or hepatic impairment with parameters of grade 3 or
             higher on the CTCAE

          -  Participants with clinically significant urinary tract obstruction and history of
             idiopathic pancreatitis

          -  Participants with presence of other known clinically significant medical and/or
             psychological illnesses precluding participation

          -  Participants who participate in clinical studies other than observational studies
             during the 90 days before the date of the informed consent form signature

          -  Participants who are unable or unwilling to complete the follow-up evaluations
             required for the study