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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023589-39 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST10 | Experimental | ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day |
|
| Placebo | Placebo Comparator | Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST10 | Drug | 30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS) | Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase | Baseline to Week 12 - double-blind phase |
| Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Mallard, PhD | Shield Therapeutics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25545376 | Result | 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. | |
| 27237709 |
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Subjects were male or female ≥18y with a confirmed diagnosis of Crohn's Disease (CD) in remission or mild-to-moderate CD (defined as CD Activity Index [CDAI] score <220 at randomization); mild-to-moderate IDA (Hb concentration ≥9.5 g/dL and <12.0 g/dL for females; ≥9.5 g/dL and <13.0 g/dL for males; serum ferritin levels <30 μg/L at Screening.
Potential subjects were selected from the general population attending each centre in UK, DE, AT or HU for routine care of their IBD and anaemia. Individuals interested in participating were invited for the Screening visit in order to assess eligibility. Written informed consent was obtained prior to conducting any study specific assessments
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| ID | Title | Description |
|---|---|---|
| FG000 | ST10 | 30mg ST10 capsules BD - double-blind phase |
| FG001 | Placebo | Matching placebo for ST10 capsules - double-blind phase |
| FG002 | ST10 - Open-label Continuation From Active Arm in Double-blind | Open-label extension of ST10 active treatment arm from double-blind phase |
| FG003 | Placebo Switch to Open-label Extension ST10 Treatment | Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
| ||||||||||||||||||
| Open-label Phase |
|
Potential subjects were screened for eligibility to participate based on their demographics, medical/surgical history, physical examination, concomitant medications, vital signs, clinical laboratory tests (including pregnancy test for females of child-bearing potential) and current IBD disease status (based on CDAI clinical score). FAS - Safety
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| ID | Title | Description |
|---|---|---|
| BG000 | ST10 | ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 12 - double-blind phase |
|
Adverse events (AEs) were solicited after informed consent and until 4 weeks after the last dose of study drug (at study completion or early termination).
Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or intercurrent illness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ST10 - Safety Set, Double-blind Phase | Adverse events reported in the double-blind phase active treatment arm with ST10 (Ferric Maltol). ST10 30 mg capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jackie Mitchell MA DPhil | Shield Therapeutics | +44 (0) 191 511 8515 | jmitchell@shieldtx.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
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| ID | Term |
|---|---|
| C115835 | ferric trimaltol |
| C062088 | ferric maltol |
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| Placebo oral capsule | Drug | Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in 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 | Baseline to Week 12 - 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 | Baseline to Week 12 - 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 | Baseline to Week 4 - double-blind phase |
| 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 | Baseline to Week 8 - double-blind phase |
| 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. | Baseline to Week 16 - open-label phase |
| 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 | Baseline to Week 20 - open-label phase |
| 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 | Baseline to Week 24 - open-label phase |
| 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 | Baseline to Week 36 - open-label phase |
| 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 | Baseline to Week 48 - open-label phase |
| 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 | Baseline to Week 64 - open-label phase |
| 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 | Baseline to Week 64 EOS - open-label phase |
| 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 | Baseline to Week 16 - open-label phase |
| 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 | Baseline to Week 36 - open-label phase |
| 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 | Baseline to Week 64 - open-label phase |
| 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 | Baseline to Week 12 - double-blind phase |
| 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 | Baseline to Week 12 - double-blind phase |
Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase |
| Baseline to Week 12 - double-blind phase |
| Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS) | Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment | Baseline to Week 64 - open-label phase |
| Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS) | 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 | Baseline to Week 64 - open-label phase |
| Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS) | 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. | Week 12 - double-blind phase |
| Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS) | 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. | Week 64 - open-label phase |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS) | 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. | Baseline to Week 12 - double-blind phase |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS) | 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. | Baseline to Week 64 - open-label phase |
| 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. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Crohn's disease (years) | Duration of Crohn's disease (years); for participants with CD | Mean | Standard Deviation | years |
|
| Time since last IBD flare-up (months) | Time since last IBD flare-up (months) recorded at baseline | Mean | Standard Deviation | months |
|
| Time since last OFP dose (months) | Time since last prior oral ferrous product (OFP) dose (months) | Mean | Standard Deviation | months |
|
| Haemoglobin concentration at baseline | Haemoglobin concentration at baseline of the 12 week double-blind phase | Mean | Standard Deviation | g/dL |
|
| Serum Ferritin concentration at baseline | Serum Ferritin concentration at baseline of the 12 week double-blind phase | Mean | Standard Deviation | μg/L |
|
| TSAT% at baseline | TSAT% (transferrin saturation %) at baseline of the 12 week double-blind phase | Mean | Standard Deviation | percentage |
|
| Crohn's Disease Activity Index (CDAI) score at baseline | Crohn's Disease Activity Index (CDAI) score at baseline (randomisation) of the 12-week double-blind phase (in study subjects 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. | Mean | Full Range | score on a scale |
|
| Irritable Bowel Disease Questionnaire (IBDQ) score at baseline | Irritable Bowel Disease Questionnaire (IBDQ) score at baseline (randomisation) of the 12 week 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. | Mean | Standard Deviation | score on a scale |
|
| OG000 | ST10 | ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase. |
| OG001 | Placebo | Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase. |
|
|
|
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase |
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| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Baseline to Week 12 - double-blind phase |
|
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| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Baseline to Week 12 - double-blind phase |
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| Secondary | 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 | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 4 - double-blind phase |
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 8 - double-blind phase |
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| Secondary | 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. | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 16 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 20 - open-label phase |
|
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 24 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 36 - open-label phase |
|
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 48 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 64 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 64 EOS - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Baseline to Week 16 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Baseline to Week 36 - open-label phase |
|
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| Secondary | 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 | FAS | Posted | Count of Participants | Participants | Baseline to Week 64 - open-label phase |
|
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| Secondary | 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 | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 12 - double-blind phase |
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| Secondary | 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 Analysis Set (FAS) | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 12 - double-blind phase |
|
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| Other Pre-specified | Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS) | Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | μg/dL | Baseline to Week 12 - double-blind phase |
|
|
|
| Other Pre-specified | Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS) | Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | percent | Baseline to Week 12 - double-blind phase |
|
|
|
| Other Pre-specified | Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS) | Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment | FAS | Posted | Mean | Standard Deviation | μg/dL | Baseline to Week 64 - open-label phase |
|
|
|
| Other Pre-specified | Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS) | 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 | FAS | Posted | Mean | Standard Deviation | percent | Baseline to Week 64 - open-label phase |
|
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|
| Other Pre-specified | Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS) | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | score on a scale | Week 12 - double-blind phase |
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| Other Pre-specified | Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS) | 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. | FAS | Posted | Mean | Standard Deviation | score on a scale | Week 64 - open-label phase |
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| Other Pre-specified | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS) | 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. | Full Analysis Set (FAS) | Posted | Median | Full Range | score on a scale | Baseline to Week 12 - double-blind phase |
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| Other Pre-specified | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS) | 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. | FAS | Posted | Median | Full Range | score on a scale | Baseline to Week 64 - open-label phase |
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|
|
| 0 |
| 64 |
| 1 |
| 64 |
| 39 |
| 64 |
| EG001 | Placebo - Safety Set, Double-blind Phase | Adverse events reported in the double-blind phase placebo treatment arm. Matching placebo capsules for ST10 taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase | 0 | 64 | 2 | 64 | 46 | 64 |
| EG002 | ST10 Continuation - Safety Set, Open-label Phase | Adverse events reported in the open-label extension phase for continuation of active treatment with ST10 (Ferric Maltol) from the double-blind phase active treatment arm | 0 | 50 | 8 | 50 | 40 | 50 |
| EG003 | Placebo Switch to ST10 Treatment-Safety Set, Open-label Phase | Adverse events reported in the open-label extension phase from those subjects continuing treatment from the double-blind placebo arm; subjects commenced ST10 open-label treatment after completion of the double-blind phase at the Week 12 visit. | 0 | 47 | 2 | 47 | 35 | 47 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rectal abscess | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cholesteatoma removal | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hernia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Sinusitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |