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Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

Phase 2
Conditions
Left-sided Ulcerative Colitis
Ulcerative Colitis
Distal Ulcerative Colitis
Interventions
Registration Number
NCT01586533
Lead Sponsor
Altheus Therapeutics, Inc.
Brief Summary

This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years.

  • They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild to moderate active disease.

  • Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI score of 4-10, inclusive, with a Physician's rating of disease score of 2 points or less (mild or moderate active ulcerative colitis), rectal bleeding score of 1 or more (based on subject diary), and mucosal appearance score (based on endoscopy) of 1 point or more at baseline.

  • Laboratory data:

    • White blood cell count between 4.0 - 12.0 K/mm3
    • Platelet count: 150 - 500 K/mm3
    • Hemoglobin > 10.0 g/dL
    • Total bilirubin < 1.5 mg/dL
    • Aspartate aminotransferase < 100 u/dL
    • Alanine aminotransferase < 100 u/dL
    • Alkaline phosphatase < 250 u/dL
    • Blood urine nitrogen < 40 mg/dL
    • Creatinine < 1.5 mg/dL
  • Satisfies one of the following:

  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.

  • Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.

  • They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria
  • They have documented history of proximal or universal ulcerative colitis, proctitis or active proctitis confined to 15cm or less from the anal verge.
  • They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
  • They receive a Physician's rating of disease severity as part of the modified UCDAI of 3 (severe disease) or an aggregate score of 11 or greater.
  • They have shown prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
  • Their stool contains enteric pathogens or Clostridium difficile toxins.
  • They have a history of recurrent Clostridium difficile infection.
  • They have prior history of biologic therapy within the previous 4 years.
  • They have received systemic steroids or immunosuppressants within the previous 4 weeks.
  • Treatment in the last 14 days that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) or mesalamine enema (Rowasa®).
  • Treatment in the last 7 days that included mesalamine (5-ASA) via oral administration (e.g. Asacol®, Lialda®, balsalazide, etc).
  • They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
  • Positive pregnancy test or lactating subjects.
  • There is evidence of chemical substance abuse.
  • They have had repeated anti-inflammatory drug treatment (longer than 3 days at doses that exceed those available without a prescription) within the previous 7 days (with exception of aspirin at doses of 325mg/day or less for prophylaxis of cardiac disease), or initiated new non-steroidal anti-inflammatory (NSAID) treatment within the last 30 days.
  • They have a known allergy to N-acetylcysteine or mesalamine, or have a history of serious AEs related to their use (including, but not limited to pancreatitis or hepatitis).
  • They have a history of failure to retain enemas.
  • Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
  • Use of any investigational medication within the previous 90 days.
  • Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mesalamine EnemaMesalamine Enema-
Primary Outcome Measures
NameTimeMethod
Change in modified UCDAI at 6 weeks6 weeks

Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine

Secondary Outcome Measures
NameTimeMethod
Time to resolution of rectal bleedingUp to 6 weeks
Clinical and endoscopic remission rates at 6 weeks6 weeks

Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline

Endoscopic improvement rate at 3 weeks3 weeks
Clinical improvement rate after 6 weeks6 weeks
Clinical improvement rate after 3 weeks3 weeks
Endoscopic improvement rate at 6 weeks6 weeks
Change from baseline in endoscopic appearance after 6 weeks6 weeks
Change from baseline in endoscopic appearance after 3 weeks3 weeks
Relapse rates at 6 weeks6 weeks
Change in modified UCDAI at 3 weeks3 weeks

Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine

Clinical and endoscopic remission rates at 3 weeks3 weeks

Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline

Trial Locations

Locations (45)

Birmingham Gastroenterology Associates

🇺🇸

Birmingham, Alabama, United States

Digestive Health Specialists of the Southeast

🇺🇸

Dothan, Alabama, United States

Rocky Mountain Gastroenterology

🇺🇸

Lakewood, Colorado, United States

Digestive Disease Associates

🇺🇸

Gainesville, Florida, United States

Digestive Medical Associates

🇺🇸

Hialeah, Florida, United States

The Center for Gastrointestinal Disorders

🇺🇸

Hollywood, Florida, United States

Miami Gastroenterology Consultants P.A.

🇺🇸

Miami, Florida, United States

South Medical Research Group

🇺🇸

Miami, Florida, United States

Gastroenterology of Naples

🇺🇸

Naples, Florida, United States

Advanced Gastroenterology Associates

🇺🇸

Palm Harbor, Florida, United States

Scroll for more (35 remaining)
Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States

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