Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
Condition: Iron Deficiency Anaemia; Inflammatory Bowel Disease; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases; Ulcer
Intervention: ST10-021; Placebo Comparator
Intervention description: 30 mg capsules to be taken orally twice a day for 12 weeks; Matching sugar pill to be taken orally twice a day for 12 weeks
Intervention MeSH terms: Ferric maltol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron deficiency; anaemia; inflammatory bowel disease; ulcerative colitis

Summary:

      The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,
      is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with
      non-active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Competency to understand and sign the IEC/IRB approved informed consent form prior to
             any study mandated procedure, and willing/able to comply with study requirements

          -  Age ≥ 18 years

          -  Current diagnosis of quiescent UC as defined by SCCAI score of < 4

          -  Current diagnosis of IDA as defined by Hb ≥ 9.5 g/dl and <12.0 g/dl for women and ≥
             9.5 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l

          -  Prior OFP failure as defined per protocol

          -  If receiving protocol-allowed immunosuppressant must be on stable dose

          -  Females of childbearing potential must agree to use a reliable method of contraception

        Exclusion Criteria:

          -  Anaemia due to any cause other than iron deficiency

          -  Intramuscular or intravenous injection or administration of depot iron preparation,
             blood infusions, or erythropoietin within 3 months

          -  Oral iron supplementation use within 1 month

          -  Use of immunosuppressant with known effect of anaemia induction within 1 month

          -  Vitamin B12 or Folic Acid injection/infusion within 4 weeks

          -  Untreated Vitamin B-12 or Folic Acid deficiency

          -  Known hypersensitivity or allergy to ST10-021 or components of the study medication,
             or contraindication for treatment with iron preparations

          -  Other chronic or acute inflammatory or infectious diseases

          -  Creatinine > 2.0 mg/dl

          -  AST or ALT levels ≥ 5 times the upper limit of normal

          -  Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine,
             metabolic, or central nervous system disease that may adversely affect the safety of
             the subject and/or efficacy of the study drug or severely limit the lifespan of the
             subject

          -  History of malignancy within the past 5 years (except in situ removal of basal cell
             carcinoma)

          -  Significant neurologic or psychiatric symptoms resulting in disorientation, memory
             impairment, or inability to report accurately that might interfere with treatment
             compliance, study conduct or interpretation of the results

          -  Participation in another interventional clinical study within 30 days or during the
             study

          -  Inmates of a psychiatric ward, prison, or other state institution

          -  Investigator or any other team member involved directly or indirectly in the conduct
             of the clinical study

          -  Scheduled or expected hospitalization and/or surgery during the course of the study

          -  Females who are pregnant or lactating