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

Primary Purpose

Iron Deficiency Anaemia, Inflammatory Bowel Disease, Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ST10
Placebo oral capsule
Sponsored by
Shield Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anaemia focused on measuring iron deficiency, anaemia, inflammatory bowel disease, Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ST10

    Placebo

    Arm Description

    ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day

    Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day

    Outcomes

    Primary Outcome Measures

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

    Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)
    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
    Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)
    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
    Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)
    Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 end of double-blind phase
    Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)
    ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation
    Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)
    ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation
    Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)
    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.
    Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)
    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
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)
    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
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)
    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
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)
    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
    Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)
    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12
    Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)
    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12

    Full Information

    First Posted
    May 10, 2011
    Last Updated
    October 5, 2020
    Sponsor
    Shield Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01352221
    Brief Title
    Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)
    Acronym
    AEGIS-2
    Official 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shield Therapeutics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anaemia, Inflammatory Bowel Disease, Crohn's Disease
    Keywords
    iron deficiency, anaemia, inflammatory bowel disease, Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ST10
    Arm Type
    Experimental
    Arm Description
    ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    ST10
    Other Intervention Name(s)
    Ferric Trimaltol, Ferric Maltol
    Intervention Description
    30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Intervention Description
    Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase
    Primary Outcome Measure Information:
    Title
    Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)
    Description
    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.
    Time Frame
    Baseline to Week 12 - double-blind phase
    Secondary Outcome Measure Information:
    Title
    Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase
    Title
    Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)
    Description
    Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 end of double-blind phase
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)
    Description
    ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation
    Time Frame
    Baseline to Week 4 - double-blind phase
    Title
    Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)
    Description
    ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation
    Time Frame
    Baseline to Week 8 - double-blind phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)
    Description
    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.
    Time Frame
    Baseline to Week 16 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 20 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 24 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 36 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 48 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 64 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 64 EOS - open-label phase
    Title
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 16 - open-label phase
    Title
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 36 - open-label phase
    Title
    Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 64 - open-label phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)
    Description
    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)
    Description
    ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12
    Time Frame
    Baseline to Week 12 - double-blind phase
    Other Pre-specified Outcome Measures:
    Title
    Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)
    Description
    Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)
    Description
    Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)
    Description
    Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment
    Time Frame
    Baseline to Week 64 - open-label phase
    Title
    Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)
    Description
    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
    Time Frame
    Baseline to Week 64 - open-label phase
    Title
    Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)
    Description
    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 Crohn's disease 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.
    Time Frame
    Week 12 - double-blind phase
    Title
    Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)
    Description
    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 Crohn's disease 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.
    Time Frame
    Week 64 - open-label phase
    Title
    Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS)
    Description
    Change from baseline (randomisation) in Crohn's Disease Activity Index (CDAI) score at Week 12 (FAS), end of double-blind phase (in subjects with CD). The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450.
    Time Frame
    Baseline to Week 12 - double-blind phase
    Title
    Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS)
    Description
    Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 64 (FAS), after 12-week double blind phase and 52 weeks open-label ST10 treatment (in participants with CD only). The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450.
    Time Frame
    Baseline to Week 64 - open-label phase

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicholas Mallard, PhD
    Organizational Affiliation
    Shield Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25545376
    Citation
    Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Buning C, Howaldt S, Stallmach A; AEGIS Study Group. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015 Mar;21(3):579-88. doi: 10.1097/MIB.0000000000000314.
    Results Reference
    result
    PubMed Identifier
    27237709
    Citation
    Schmidt C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Howaldt S, Stallmach A, Buning C; AEGIS Study Group. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study. Aliment Pharmacol Ther. 2016 Aug;44(3):259-70. doi: 10.1111/apt.13665. Epub 2016 May 29.
    Results Reference
    result

    Learn more about this trial

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

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