Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)

NCT ID: NCT01352221

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-10-31

Brief 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 Crohn's Disease (CD).

Detailed Description

As no curative treatment is currently available for Crohn's Disease (CD), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of CD. Iron deficiency anaemia in CD is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with CD suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in CD is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with CD.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including CD.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active CD. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Conditions

Iron Deficiency Anaemia; Inflammatory Bowel Disease; Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ST10

ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day

Group Type: EXPERIMENTAL

ST10

Intervention Type: DRUG

30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase

Placebo

Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase

Interventions

ST10

30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase

Intervention Type: DRUG

Placebo oral capsule

Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase

Intervention Type: DRUG

Other Intervention Names

Ferric Trimaltol; Ferric Maltol

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 CD as defined by CDAI score of < 220
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shield Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Mallard, PhD

Role: STUDY_DIRECTOR

Shield Therapeutics

References

Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Buning C, Howaldt S, Stallmach A; AEGIS Study Group. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015 Mar;21(3):579-88. doi: 10.1097/MIB.0000000000000314.

Reference Type: RESULT

PMID: 25545376 (View on PubMed)

Schmidt C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Howaldt S, Stallmach A, Buning C; AEGIS Study Group. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study. Aliment Pharmacol Ther. 2016 Aug;44(3):259-70. doi: 10.1111/apt.13665. Epub 2016 May 29.

Reference Type: RESULT

PMID: 27237709 (View on PubMed)

Other Identifiers

2010-023589-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ST10-01-302

Identifier Type: -

Identifier Source: org_study_id