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Completed

NCT Number: NCT01340872

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

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 ulcerative colitis (UC).

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Key information

Conditions

Iron Deficiency Anaemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

As no curative treatment is currently available for ulcerative colitis (UC), 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 UC. Iron deficiency anaemia in UC 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 UC suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in UC 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 UC.

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 UC.

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 UC. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ST10-021

Drug

30 mg capsules to be taken orally twice a day for 12 weeks

Other names: Ferric Trimaltol, Ferric maltol, Feraccru

placebo comparator

Drug

Matching sugar pill to be taken orally twice a day for 12 weeks

Primary outcomes

  1. Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 12 - double-blind phase

    Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.

Secondary outcomes

  1. 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

    Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase

  2. 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

    Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase

  3. 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

    Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 - end of double-blind phase

  4. Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 4 - double-blind phase

    ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation

  5. Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 8 - double-blind phase

    ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation

  6. 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 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.

  7. Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 20 - open-label phase

    Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment

  8. 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 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment

  9. Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 36 - open-label phase

    Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment

  10. 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 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment

  11. Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 64 - open-label phase

    Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment

  12. Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)

    Time frame: Baseline to Week 64 EOS - open-label phase

    Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days

  13. 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

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment

  14. 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

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment

  15. 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

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment

Other outcomes

  1. Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)

    Time frame: Baseline to Week 12 - double-blind phase

    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12

  2. Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)

    Time frame: Baseline to Week 12 - double-blind phase

    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12

  3. Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 12 - double-blind phase

    Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase

  4. Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 64 - open-label phase

    Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment

  5. Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 12 - double-blind phase

    Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase

  6. Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 64 - open-label phase

    Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment

  7. Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)

    Time frame: Week 12 - double-blind phase

    Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.

    The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190.

  8. Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)

    Time frame: Week 64 - open-label phase

    Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.

    The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190.

  9. Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 12 (Full Analysis Set, FAS)

    Time frame: Baseline to Week 12 - double-blind phase

    Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 12 (FAS), end of double-blind phase (in subjects with UC).

    The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.

    The score is determined by asking the person with UC questions regarding:

    • bowel frequency at day/night
    • urgency of defecation
    • blood in stool
    • general health
    • extracolonic manifestations

  10. Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 64 (Full Analysis Set)

    Time frame: Baseline to Week 64 - open-label phase

    Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (in participants with UC only).

    The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.

    The score is determined by asking the person with UC questions regarding:

    • bowel frequency at day/night
    • urgency of defecation
    • blood in stool
    • general health
    • extracolonic manifestations

Sponsors and collaborators

Lead sponsor

Shield Therapeutics

Industry

Registry information

Official study 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)

Acronym: AEGIS-1

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 25, 2011
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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