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

Shield Therapeutics

Status and phase

Completed

Phase 3

Conditions

Inflammatory Bowel Disease

Iron Deficiency Anaemia

Crohn's Disease

Treatments

Drug: ST10

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01352221

2010-023589-39 (EudraCT Number)

ST10-01-302

Details and patient eligibility

About

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).

Full 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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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