ST10-021 for IDA in quiescent CD
Research type
Research Study
Full title
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn’s Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2)
IRAS ID
81541
Sponsor organisation
Iron Therapeutics (Switzerland) AG
Eudract number
2010-023589-39
Clinicaltrials.gov Identifier
Research summary
Crohn's disease (CD) is an inflammatory disease of the gastrointestinal tract. The condition is grouped under the general term, inflammatory bowel disease. Symptoms of CD include diarrhoea, abdominal pain, fever, and signs of an intestinal obstruction. CD may also cause complications outside the gastrointestinal tract such as skin rashes, arthritis and inflammation of the eye. Remission refers to a disease becoming inactive for a period of time. To be eligible for this study, patients must have inactive or minimally active CD. A lack of iron in the blood is defined as iron deficiency anaemia (IDA). IDA is a serious complication and a key symptom of CD. Patients with CD commonly present with anaemia because of inadequate absorption of iron in the intestine, and because of blood loss. Oral iron therapy is a common treatment for IDA. At the current time, oral iron therapy is available as ferrous iron, which in chemical terms is Fe2. Ferrous iron is not efficiently absorbed in the intestine, and unabsorbed iron commonly causes adverse effects such as nausea, abdominal pain, and constipation. Thus, patients taking oral ferrous iron commonly experience worsening of their CD symptoms. Iron therapies can be injected directly into the blood, however, this can have side effects including pain, infection from the line, or a serious allergic reaction to the iron.It is anticipated that the study drug, ST10-021, a new form of oral iron therapy, will be better tolerated compared with currently available oral iron therapies. This randomised study will investigate the tolerability and effectiveness in improving iron levels in the blood from study start to Week 12 in patients receiving ST10-021 versus placebo. Patients can participate if they have previously failed or cannot use oral ferrous therapies, and have a current diagnosis of non-active or minimally active CD.
REC name
London - Riverside Research Ethics Committee
REC reference
11/LO/0805
Date of REC Opinion
2 Aug 2011
REC opinion
Further Information Favourable Opinion