Clinical Trials Register

Summary
EudraCT Number:	2010-023589-39
Sponsor's Protocol Code Number:	ST10-01-302
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-05-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2010-023589-39

A.3

Full title of the trial

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)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)

A.3.2

Name or abbreviated title of the trial where available

ST10-021 for IDA in quiescent CD

A.4.1

Sponsor's protocol code number

ST10-01-302

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01352221

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Iron Therapeutics (Switzerland) AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Iron Therapeutics (Switzerland) AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Iron Therapeutics (Switzerland) AG
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Sihleggstrasse 23
B.5.3.2	Town/ city	Wollerau
B.5.3.3	Post code	CH-8832
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	44191511 8510
B.5.5	Fax number	44808280 2209
B.5.6	E-mail	jmitchell@shieldtx.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ST10-021
D.3.2	Product code	ST10-021
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	33725-54-1
D.3.9.2	Current sponsor code	ST10-021
D.3.9.3	Other descriptive name	3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Iron deficiency anaemia in quiescent Crohn's Disease

E.1.1.1

Medical condition in easily understood language

Iron deficiency anaemia in non-active Crohn's Disease

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10022972
E.1.2	Term	Iron deficiency anaemia
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10002062
E.1.2	Term	Anaemia iron deficiency
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the efficacy of oral ST10-021 in the treatment of iron deficiency anaemia (IDA), as measured by change in haemoglobin (Hb) concentration from baseline to Week 12, in subjects with quiescent Crohn's Disease (CD) where oral ferrous preparations (OFP) have failed or cannot be used.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of ST10-021 in subjects with IDA and CD, where OFP have failed or cannot be used, over a treatment duration of up to 12 weeks.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 1. Subject must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure
2. Subject must be willing and able to comply with study requirements
3. Subject must be at least 18 years of age
4. Subject must have a current diagnosis of quiescent CD and IDA, as defined by the following criteria:
a. Subject must have quiescent CD defined by a Crohn’s Disease Activity Index (CDAI) score of < 220 at the Randomisation Visit
b. Subject must have anaemia defined by Hb  9.5 g/dl and <12.0 g/dl (5.9 - 7.5 mmol/l) for females and 9.5 g/dl and <13.0 g/dl (5.9 - 8.1 mmol/l) for males as measured at the Screening Visit
c. Subject must have iron deficiency defined by ferritin < 30 µg/l as measured at the Screening Visit
5. Subject must have failed OFP in the past. Failure defined by:
a. Adverse drug effects that led to withdrawal from OFP (at least one of the following: nausea, diarrhoea, constipation, abdominal pain, flatulence) and/or
b. Deterioration of the primary disease caused by OFP and/or
c. Lack of efficacy and/or
d. Other signs of failure to OFP or reasons why OFP cannot be used as documented by the Investigator
6. Subject receiving protocol-allowed immunosuppressants at screening must have been on stable dose for at least 4 weeks prior to randomisation. Allowed immunosuppressants include azathioprine, 6-mercaptopurine, TNF-alpha antagonists and corticosteroid doses less than or equal to the equivalent of 25mg/day prednisolone.
7. Female subject of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomised partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate

E.4

Principal exclusion criteria

1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to,
a. Untreated or untreatable severe malabsorption syndrome
b. Immunosuppressant use
2. Subject who has received within 12 weeks prior to randomisation
a. Intramuscular or intravenous (IV) injection or administration of depot iron preparation
b. Blood transfusion
c. Erythropoietin
3. Subject who has received within 4 weeks prior to randomisation
a. Oral iron supplementation
b. Immunosuppressant with known effect of anaemia induction, including, but not limited to methotrexate, cyclosporin A or tacrolimus
4. Subject who has received Vitamin B12 injections/infusions within 4 weeks prior to randomisation.

5. Subject who has received a Folic Acid injection/infusion within 4 weeks prior to randomisation.

6. Subject with or Vitamin B-12 concentration below the lower limit of normal (LLN) as measured at the Screening Visit.
7. Subject with or folic acid deficiency as measured at the Screening Visit.
8. Subject with known hypersensitivity or allergy to ST10-021 or components of the study medication
9. Subject with contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassaemia, or lead intoxication induced anaemia
10. Subject with creatinine > 2.0 mg/dl (176 µmol/l) as measured at the Screening Visit
11. Subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal as measured at the Screening Visit
12. Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject
13. Subject with history of malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma
14. Subject with 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 (e.g., Alzheimer’s disease, schizophrenia or other psychosis, alcohol or drug abuse)
15. Participation in another interventional clinical study within 4 weeks prior to randomisation or during the study
16. Subject who is an inmate of a psychiatric ward, prison, or other state institution
17. Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
18. Subject with scheduled or expected hospitalisation and/or surgery during the course of the study
19. Female subject who is pregnant or lactating

E.5 End points

E.5.1

Primary end point(s)

Change in Hb concentration from baseline to Week 12

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, Week 12

E.5.2

Secondary end point(s)

Secondary Endpoints:
• • Proportion of subjects that achieve an increase in Hb concentration of ≥1 g/dl at Week 12
• Proportion of subjects that achieve an increase in Hb concentration of ≥2 g/dl at Week 12
• Proportion of subjects that achieve Hb concentration within normal range at Week 12
• Change in Hb concentration from baseline to Week 8
• Change in Hb concentration from baseline to Week 4 (early response)

Baseline is defined as Day 0 for the above endpoints

Safety endpoints will include:
• Treatment-emergent Adverse Events (AEs)
• Treatment-emergent Serious Adverse Events (SAEs)
• Adverse Events leading to premature discontinuation of study drug
• Change from baseline to Week 12 of CDAI
• Change from baseline to Week 12 in vital signs
• Change from baseline to Week 12 in body weight
• Treatment-emergent clinically relevant laboratory abnormalities

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, Weeks 2, 4, 8, 12,14

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of Life

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects who complete the study per protocol may be eligible to continue to receive study medication via a second protocol or via an expanded access program until such time as the medication becomes commercially available

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-10-14

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