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

NCT07739368 | Completed Phase 3

• 1 other identifier: ASK109-LC-1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Ferric Maltol, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).

Conditions

Iron Deficiency Anaemia

Outcome Measures

Primary Outcomes (1)

• Change in Haemoglobin (Hb) Concentration From Baseline to Week 12

  Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit. A mixed-effects model for repeated measures (MMRM) was used for the statistical analysis of the change in Hb from baseline after treatment. The model used the change in Hb from baseline at each post-treatment time point as the dependent variable, baseline Hb as a covariate, treatment group, visit, disease at screening (UC or CD), treatment group × visit interaction, and baseline Hb × visit interaction as fixed effects, and subject as a random effect.

  Baseline to Week 12

Secondary Outcomes (11)

• Proportion of Subjects That Achieved ≥10 g/L Change From Baseline in Hb Concentration at Week 12

  Baseline to Week 12

• Proportion of Subjects That Achieved ≥20 g/L Change From Baseline in Hb Concentration at Week 12

  Baseline to Week 12

• Proportion of subjects with Hb concentration within the normal range at Week 12

  Baseline to Week 12

• Change in Hb concentration from baseline to Week 4

  Baseline to Week 4

• Change in Hb concentration from baseline to Week 8

  Baseline to Week 8

Study Arms (2)

Ferric Maltol

ACTIVE COMPARATOR

30mg capsules, taken orally twice a day

Drug: Ferric Maltol

Matching placebo capsules for Ferric Maltol

PLACEBO COMPARATOR

taken orally twice a day

Drug: Placebo Oral Capsule

Interventions

Ferric Maltol DRUG

30 mg capsules to be taken orally twice a day for 12 weeks

Ferric Maltol

Placebo Oral Capsule DRUG

Matching placebo capsules for Ferric Maltol to be taken orally twice a day for 12 weeks

Matching placebo capsules for Ferric Maltol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jiangsu Aosaikang Pharm

Nanjing, China

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 31, 2026
• Study Start: September 1, 2021
• Primary Completion: February 20, 2025
• Study Completion: March 20, 2025
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)