A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)

• Conditions: Iron deficiency anaemia in quiescent ulcerative colitis; MedDRA version: 14.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.1Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-023588-16-HU
• Lead Sponsor: Iron Therapeutics (Switzerland) AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-27
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.1.Subject must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure
2.Subject must be willing and able to comply with study requirements
3.Subject must be at least 18 years of age
4.Subject must have a current diagnosis of quiescent UC and IDA, as defined by following criteria:
a.Subject must have quiescent UC defined by a Simple Clinical Colitis Activity Index of <4 at the Screening Visit and at the Randomisation Visit
b.Subject must have anaemia defined by Hb ? 9.5 g/dl and <12.0 g/dl (5.9- 7.5 mmol/l) for females and ? 9.5 g/dl and <13.0 g/dl (5.9- 8.1 mmol/l) for males as measured at the Screening Visit
c. Subject must have iron deficiency defined by ferritin < 30 µg/l as measured at the Screening Visit
5.Subject must have failed OFP in the past. Failure defined by:
a.Adverse drug effects that led to withdrawal from OFP (at least one of the following: nausea, diarrhoea, constipation, abdominal pain, flatulence) and/or
b.Deterioration of the primary disease caused by OFP and/or
c.Lack of efficacy and/or
d.Other signs of failure to OFP or reasons why OFP cannot be used as documented by the Investigator
6.Subject receiving protocol-allowed immunosuppressants at screening must have been on stable dose for at least 4 weeks prior to randomisation. Allowed immunosuppressants include azathioprine, 6-mercaptopurine, TNF-alpha antagonists and corticosteroid doses less than or equal to the equivalent of 25 mg/day prednisolone
7.Female subject of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomised partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1.1.Subject with anaemia due to any cause other than iron deficiency, including, but not limited to,
a.Untreated or untreatable severe malabsorption syndrome
b.Immunosuppressant use
2.Subject who has received within 12 weeks prior to randomisation
a.Intramuscular or iv injection or administration of depot iron preparation
b.Blood transfusion
c.Erythropoietin
3.Subject who has received within 4 weeks prior to randomisation
a.Oral iron supplementation
b.Immunosuppressant with known effect of anaemia induction, including, but not limited to methotrexate, cyclosporin A or tacrolimus
4.Subject who has received Vitamin B12 injections/infusions within 4 weeks prior to randomisation.
5.Subject who has received a Folic Acid injection/infusion within 4 weeks prior to randomisation.
6.Subject with Vitamin B12 concentration below the lower limit of normal (LLN) as measured at the Screening Visit.
7.Subject with folic acid deficiency as measured at the Screening Visit.
8.Subject with known hypersensitivity or allergy to ST10-021 or components of the study medication
9.Subject with contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassaemia, or lead intoxication induced anaemia
10.Subject with creatinine > 2.0 mg/dl (176 µmol/l) as measured at the Screening Visit
11.Subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels = 5 times the upper limit of normal (ULN) as measured at the Screening Visit
12.Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject
13.Subject with history of malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma
14.Subject with significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately or that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer’s disease, schizophrenia or other psychosis, alcohol or drug abuse)
15.Participation in another interventional clinical study within 4 weeks prior to randomisation or during the study
16.Subject who is an inmate of a psychiatric ward, prison, or other state institution
17.Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
18.Subject with scheduled or expected hospitalisation and/or surgery during the course of the study
19.Female subject who is pregnant or lactating

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified