Phase 3
N=128
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)
Iron Deficiency Anaemia · Inflammatory Bowel Disease · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01352221 ↗Enrolled (actual)
128
Serious AEs
5.8%
Results posted
Oct 2017
Primary outcome: Primary: Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS) — 2.26; 0.01 g/dL — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ST10 (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shield Therapeutics
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS) |
2.26; 0.01 | < 0.0001 sig |
| SECONDARY Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS) |
50; 7; 14; 57 | — |
| SECONDARY Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS) |
36; 0; 28; 64 | — |
| SECONDARY Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS) |
42; 8; 22; 56 | — |
| SECONDARY Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS) |
1.08; 0 | < 0.0001 sig |
| SECONDARY Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS) |
1.79; 0.04 | < 0.0001 sig |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS) |
2.34; 1.04 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS) |
2.45; 1.46 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS) |
2.68; 1.87 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS) |
2.85; 2.17 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS) |
3.09; 2.0 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS) |
3.07; 2.19 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS) |
1.32; 0.52 | — |
| SECONDARY Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS) |
36; 17; 10; 28 | — |
| SECONDARY Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS) |
35; 29; 6; 7 | — |
| SECONDARY Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS) |
31; 30; 5; 6 | — |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS) |
2.23; 0.05 | < 0.0001 sig |
| SECONDARY Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF) |
2.11; -0.03 | < 0.0001 sig |
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).
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 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
Data sourced from ClinicalTrials.gov (NCT01352221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.