The study will evaluate the effectiveness, safety and tolerability of tacrolimus lipid suspension for enema in adult patients with mild to moderately active ulcerative colitis who had an inadequate response or intolerance of at least 1 of aminosalicylates (5-ASAs), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy. There will be approximately 150 male and female subjects of 18 and 65 years of age enrolled. Patients will be randomized into two groups where Tacrolimus Lipid Suspension for Enema or Placebo (Tacrolimus-free) Lipid Suspension for Enema will be administered rectally once daily for 28 days.
Male and female patients ≥ 18 years and ≤ 65 years of age.
Patients have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole or part of the left side of the colon [approximately 60 cm up from the anus (anal verge) to splenic flexure of colon], with mild to moderate active disease.
Patients with a score of at least 4 on the modified Mayo Score (mMS), including an endoscopy subscore of at least 2 and a rectal bleeding subscore of at least 1.
Patients who have inadequate response, loss of response, or intolerance of at least 1 of aminosalicylates (5-ASAs) (mesalamine, sulfasalazine, olsalazine, basalazide), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy as per the discretion of the Investigator.
Documented history of proximal or universal ulcerative colitis (pan colitis).
Patients who receive mMS score of 8 or greater (severe disease)
Patients with known allergy to study drugs or have a history of serious AEs related to their use.
Patients who 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.
Parallel
Tacrolimus Lipid Suspension for enema
DrugTacrolimus Lipid Suspension for enema 4 mg/vial
Identical Tacrolimus-free Lipid Suspension for Enema
DrugIdentical Tacrolimus-free Lipid Suspension for Enema
Proportion of patients in clinical remission
Proportion of patients in clinical remission at week 4 will be calculated and reported. The difference between proportions of patients in clinical remission for test treatment and placebo and its 95% confidence interval will be calculated and reported
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Jina Pharmaceuticals Inc.
Lead sponsor
Novum Pharmaceutical Research Services
Collaborator
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