Safety and Efficacy Study of Ferric Maltol To Treat Iron Deficiency Anaemia in Chinese Patients With Inflammatory Bowel Disease

Inclusion criteria

• Age ≥ 18 years at the time of signing the informed consent form, male or female;
• UC or CD, with a Simple Clinical Colitis Activity Index (SCCAI) score < 5 or a Crohn's Disease Activity Index (CDAI) score < 220 at the screening visit;
• Anaemia, with Hb levels tested at the screening visit as follows: Hb ≥ 85 g/L and < 110 g/L for females, Hb ≥ 85 g/L and < 120 g/L for males;
• SIron deficiency, defined as ferritin < 30 µg/L at the screening visit, or ferritin < 100 µg/L and transferrin sa

Exclusion criteria

• Anaemia due to any cause other than iron deficiency, including but not limited to: untreated or untreatable severe malabsorption syndrome;
• Subjects who have received the following treatments within 12 weeks prior to randomization

• Blood transfusion
• Erythropoietin
• Prolyl hydroxylase inhibitors
• Subjects who have received the following treatments within 4 weeks prior to screening

• Oral/intramuscular/intravenous iron preparations (including sustained-release iron preparations)
• Immunosuppressants known to induce anaemia, including but not limited to methotrexate, cyclosporine A, or tacrolimus
• Traditional Chinese medicine prescriptions, herbs, or proprietary Chinese medicines with blood-tonifying effects (with anaemia as an indication in the package insert)
• Vitamin B12 or folic acid measured at the screening visit was below the lower limit of normal;
• Subjects with known hypersensitivity or allergy to ferric maltol or any component of the investigational medicinal product;
• Subjects with known contraindications to iron preparation therapy, such as hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead poisoning-induced anaemia;
• Subjects with creatinine > 1.5 times the upper limit of normal measured at the screening visit;
• Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal measured at the screening visit;
• Subjects with severe cardiovascular, hepatic, renal, hematological, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases, which in the investigator's opinion might adversely affect the subject's safety and/or the efficacy of the investigational drug;
• Subjects with a history of malignancy within the past 5 years, except for excised basal cell carcinoma in situ;
• Subjects with significant neurological or psychiatric disorders leading to disorientation, memory impairment, or inability to report accurately, which might interfere with treatment compliance, study conduct, or interpretation of results (e.g., Alzheimer's disease, depression, anxiety, schizophrenia or other psychiatric disorders, alcohol or drug abuse);
• Subjects who have participated in another interventional clinical study within 4 weeks prior to randomization or would participate during this study;
• Subjects who are inmates of psychiatric hospitals or prisons;
• Female subjects who are pregnant or breastfeeding;
• Other situations deemed by the investigator as unsuitable for the patient to participate in this study.