Clinical Trials Register

Summary
EudraCT Number:	2012-000714-11
Sponsor's Protocol Code Number:	IM101-291
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-05
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

Czechia - SUKL

A.2

EudraCT number

2012-000714-11

A.3

Full title of the trial

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil (MMF) and Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis

Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 14-Sep-12)

Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 3 hodnotící účinnost a bezpečnost BMS-188667 (abatacept) nebo placeba, obojí v kombinaci s mykofenolát mofetilem (MMF) a kortikosteroidy, u pacientů s aktivní lupusovou nefritidou III. nebo IV. třídy.

Dodatek č. 1 pro farmakogenetický výzkum vzorků krve – specifický dle centra (verze 1.0 datovaná 14. září 2012)

A.3.1

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

Efficacy and Safety Study of Abatacept to treat Lupus Nephritis

A.3.2

Name or abbreviated title of the trial where available

ALLURE

A.4.1

Sponsor's protocol code number

IM101-291

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01714817

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	ABATACEPT
D.3.2	Product code	BMS-188667
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABATACEPT
D.3.9.1	CAS number	332348-12-6
D.3.9.2	Current sponsor code	BMS-188667
D.3.9.4	EV Substance Code	SUB20635
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	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	genetically engineered fusion protein
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Myfenax
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Film-coated tablet
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.3.8	INN - Proposed INN	MYCOPHENOLATE MOFETIL
D.3.9.2	Current sponsor code	MMF
D.3.9.3	Other descriptive name	MYCOPHENOLATE MOFETIL
D.3.9.4	EV Substance Code	SUB03360MIG
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	500
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.IMP: 3
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	Abatacept
D.3.2	Product code	BMS-188667
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABATACEPT
D.3.9.1	CAS number	332348-12-6
D.3.9.2	Current sponsor code	BMS-188667
D.3.9.4	EV Substance Code	SUB20635
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	125
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	fusion protein

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	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active Class III or IV lupus glomerulonephritis

E.1.1.1

Medical condition in easily understood language

Lupus Nephritis

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10025140
E.1.2	Term	Lupus nephritis
E.1.2	System Organ Class	10038359 - Renal and urinary 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

The primary objective of this study is to compare the proportion of subjects with Complete Renal Response (CR) of lupus glomerulonephritis (as defined in Section 5.4.1.1 of the study protocol) at Day 365 following 1 year treatment with abatacept or placebo administered on a background of MMF and corticosteroids.

E.2.2

Secondary objectives of the trial

Key Secondary Objectives:
1) Compare the proportion of nephrotic subjects with Complete Renal Response (CR) of lupus glomerulonephritis (LP) at Day 365 following 1 year treatment with Abatacept or placebo administered on a background of MMF and corticosteroids (CS).
2) Compare the mean change from baseline in UPCR at Day 365 following 1 year treatment with Abatacept or placebo administered on a background of MMF and CS in nephrotic subjects.
3) Compare the mean change from baseline in UPCR at Day 365 following 1 year treatment with Abatacept or placebo administered on a background of MMF and CS in overall population.
4) Compare the proportion of nephrotic subjects with CR of LP at Day 729 following 2 years treatment with Abatacept or placebo administered on a background of MMF and CS.
5) Compare the proportion of subjects in overall population with CR of LP at Day 729 following 2 years treatment with Abatacept or placebo administered on a background of MMF and CS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a) SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincidentally.
b) Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
c) Biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding IIIc, IVd).
d) Evidence of active disease within 3 months of Screening, based on at least one of the following:
i) Renal Flare
ii) UPCR ≥ 3 at Screening
iii) Active urine sediment, defined as at least one of the following:
•≥ 5 red blood cells (RBC) per high power field (hpf)
•≥ 5 white blood cells (WBC) per hpf
•presence of cellular casts
iv) Biopsy within 3 months prior to screening visit indicating active proliferative lupus glomerulonephritis.
e) Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L).

Additionally, clarified per Protocol Amendment 07:
- This study allows the re-enrollment of subjects who have been discontinued as
pre-treatment failures. If re-enrolled, the subject must be re-consented and all screening procedures re-assessed with the exception of the chest x-ray, ECG and TB screen.

Inclusion criteria for the Long-Term Extension period
a) Signed Written Informed Consent
b) Subjects who complete 104 weeks of double-blind treatment and have achieved a
complete or partial renal response at Day 701 (based on lab results from Day 701 or 722,
if needed) as defined in Sections 5.4.1.1 and 5.4.1.2.

E.4

Principal exclusion criteria

a) Subjects with drug-induced SLE, as opposed to idiopathic SLE.
b) Subjects with autoimmune disease other than SLE as their main diagnosis (eg; RA, MS).
c) Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
d) Active CNS lupus (BILAG A or B) with the exception of fatigue or mild stable cognitive dysfunction (screening MRI or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease).
e) Subjects who are diagnosed as end-stage renal disease.
f) Subjects with persistent non-lupus related pyuria or hematuria (eg, hemorrhagic cystitis).
g) Subjects with a degree of tubulo-interstitial changes that suggests a significant and irreversible decrease in renal function

Additionally clarified, per Protocol Amendment 07:
- Subjects on hydroxychloroquine, chloroquine or quinacrine with retinopathy diagnosed within 6 months of screening visit. Subjects receiving anti-malarial therapy who are unwilling to follow local standards for routine ophthalmologic follow-up.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for a minimum of 10 weeks (or longer as required by local guidelines) after the dose of study medication.
- Subject who will have need of a live vaccine at any time between enrollment (initiation of screening) or within 3 months of discontinuation from the study.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 365

E.5.2

Secondary end point(s)

Efficacy endpoints:
1. Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis at Day 365.
2. Mean change in UPCR from baseline at Day 365 in nephrotic subjects.
3. Mean change in UPCR from baseline at Day 365 in overall population.
4. Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis at Day 729
5. Proportion of subjects with complete renal response of lupus glomerulonephritis in overall population at Day 729
6. Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response at Day 365
7. Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response at Day 729
8. Time to achieving first complete renal response during the double-blind period
9. Time to achieving first partial renal response during the double-blind period
10. Proportion of subjects meeting each of the components of PR and CR over time during the double-blind
11. Mean change from baseline in disease activity as measured by BILAG 2004 over time during the double-blind period
12. Time to and proportion of subjects with sustained change to lower level of response, ie, CR to PR or NR, PR to NR (sustained response is defined as response present at 2 consecutive visits) during the double-blind period
13. Time to first lupus treatment failure and proportion of subjects in lupus treatment failures overall, and after achievement of CR or PR during the double-blind period
14. Time to first overall treatment failure and proportion of subjects in lupus treatment failure overall, and after achievement of CR or PR during the double-blind period

Safety Endpoints:
• All adverse events (AEs/SAEs)
• AEs of interest (infections, malignancies, autoimmune disorders, infusional reactions and injection site reactions)
• Vital signs
• Laboratory test abnormalities

Immunogenicity endpoint:
• Proportion of subjects with abatacept induced antibody response over time in the double blind period.

Pharmacokinetic endpoints:
• Cmin (microg/mL): Trough level serum concentration of abatacept prior to the administration of the intravenous infusion on Days 1, 15, 29, 57, 85, 113,169, 281, 337, will be tabulated by study day.
• Cmax (microg/mL): Maximum observed serum concentration following subjects receiving active abatacept IV (at 1 hour post Day 1 dose and 30 minutes post Day 337 dose) will be obtained and tabulated.
• AUC (TAU) (microg•h/mL): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.

E.5.2.1

Timepoint(s) of evaluation of this end point

-At Day 365
-At Day 729
-At Day 729
-At Day 365
-At Day 365
-At Day 365
Efficacy endpoints:
1.Day 365
2.Day 365
3.Day 365
4.Day 729
5.Day 729
6.Day 365
7.Day 729
8.Day 15 to Day 729
9.Day 15 to Day 729
10.Day 15 to Day 729
11.Day 15 to Day 729
12.Day 15 to Day 729
13.Day 15 to Day 729
14.Day 15 to Day 729

Safety Endpoints:
•Day 15 to Day 729
•infections, malignancies, autoimmune disorders, infusional reactions: Day 15 to Day 729. Injection site reactions: Day 897 to Day 1065
•Day 15 to Day 729
•Day 15 to Day 729

Immunogenicity endpoint:
•Day 15 to Day 729

Pharmacokinetic endpoints:
•Cmin : Days 1, 15, 29, 57, 85, 113,169, 281, 337, will be tabulated by study day
•Cmax : Day 1 to Day 337
•AUC (TAU): Days 337 to 365

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers; Outcomes Research Assessments; Immunogenicity Assessments

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

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Czech Republic

Hong Kong

Italy

Japan

Korea, Republic of

Mexico

Peru

Romania

Russian Federation

Taiwan

United States

E.8.7

Trial has a data monitoring committee

Yes

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, Subjects who received study treatment (MMF only or MMF and abatacept) will be required to complete the post-treatment follow-up visits at Day 85 and Day 169 after the last dose of treatment was administered; unless the subject withdraws consent.

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.1.1.1

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:

539

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

544

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)

All efforts must be made to secure access to the standard of care treatment for patients who complete the study or discontinue participation before December 1, 2017.
BMS will work with the sites to provide MMF via a post-study drug access program (PSDP) for one additional year (where regional regulations allow) for subjects who do not have commercial access or are unable to obtain MMF from a government sponsored or private health program.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-30

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