Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01340872
• Date of registration: 19/04/2011
• Prospective Registration: Yes
• Primary sponsor: Shield Therapeutics
• Public title: Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) AEGIS-1
• Scientific 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 Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)
• Date of first enrolment: August 2011
• Target sample size: 128
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01340872
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, United Kingdom

Contacts

• Name: Nicholas Mallard, PhD
• Affiliation: Shield Therapeutics

Key inclusion & exclusion 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 UC as defined by SCCAI score of < 4

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Iron Deficiency Anaemia

Ulcerative Colitis

Intervention(s)

Drug: Placebo Comparator

Drug: ST10-021

Primary Outcome(s)

Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 12 - double-blind phase]

Secondary Outcome(s)

Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 36 - open-label phase]

Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 64 - open-label phase]

Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 4 - double-blind phase]

Proportion of Subjects That Achieved =1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS) [Time Frame: Subjects that achieved =1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase]

Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 16 - open-label phase]

Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 16 - open-label phase]

Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS) [Time Frame: Baseline to Week 64 EOS - open-label phase]

Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 36 - open-label phase]

Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 20 - open-label phase]

Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 8 - double-blind phase]

Proportion of Subjects That Achieved =2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 12 - double-blind phase]

Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 12 - double-blind phase]

Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 24 - open-label phase]

Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 48 - open-label phase]

Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS) [Time Frame: Baseline to Week 64 - open-label phase]

Secondary ID(s)

ST10-01-301

2010-023588-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01340872