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

NCT01340872 | Completed Phase 3 Results

• 2 other identifiers: ST10-01-3012010-023588-16
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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 ulcerative colitis (UC).

Conditions

Iron Deficiency Anaemia; Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

iron deficiency; anaemia; inflammatory bowel disease; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 12 - double-blind phase

Secondary Outcomes (15)

• Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)

  Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase

• Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)

  Baseline to Week 12 - double-blind phase

• Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)

  Baseline to Week 12 - double-blind phase

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

  Baseline to Week 4 - double-blind phase

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

  Baseline to Week 8 - double-blind phase

Other Outcomes (10)

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

  Baseline to Week 12 - double-blind phase

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

  Baseline to Week 12 - double-blind phase

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

  Baseline to Week 12 - double-blind phase

Study Arms (2)

ST10

EXPERIMENTAL

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

Drug: ST10-021

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Comparator

Interventions

ST10-021 DRUG

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

Also known as: Ferric Trimaltol, Ferric maltol, Feraccru

ST10

Placebo Comparator DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shield Therapeutics: lead

Related Publications (2)

• 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.

  PMID: 25545376 RESULT

• 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.

  PMID: 27237709 RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Diseases; Colitis, Ulcerative; Iron Deficiencies; Anemia

Interventions

ferric trimaltol; ferric maltol

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Jackie Mitchell MA DPhil
• Organization: Shield Therapeutics

jmitchell@shieldtx.com

+44 (0) 191 511 8515

Study Officials

• Nicholas Mallard, PhD

  Shield Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 25, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: October 30, 2020
• Results First Posted: August 3, 2018

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share