Clinical Trials Register

Summary
EudraCT Number:	2015-004775-78
Sponsor's Protocol Code Number:	1014802-203
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-06-01
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

Netherlands - Competent Authority

A.2

EudraCT number

2015-004775-78

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Een Gerandomiseerde, Dubbelblinde, Placebogecontrolleerde, Parallelle Groepen Studie om de Effectiviteit en Veiligheid van BIIB074 te evalueren bij Patiënten met Neuropathische Pijn door Lumbosacrale Radiculopathie

A.3.1

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

Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Studie om de effectiviteit en veiligheid van BIIB074 te evalueren bij Patiënten met Pijn door Lumbosacrale Radiculopathie.

A.4.1

Sponsor's protocol code number

1014802-203

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	Convergence Pharmaceuticals Ltd
B.1.3.4	Country	United Kingdom
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	Convergence Pharmaceuticals Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Convergence Pharmaceuticals Ltd
B.5.2	Functional name of contact point	N/A
B.5.3	Address:
B.5.3.1	Street Address	Maia Building, Babraham Research Campus
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	CB22 3AT
B.5.3.4	Country	United Kingdom
B.5.6	E-mail	clinicaltrials@biogen.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	BIIB074
D.3.2	Product code	BIIB074
D.3.4	Pharmaceutical form	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	Raxatrigine (proposed)
D.3.9.1	CAS number	934240-31-0
D.3.9.2	Current sponsor code	BIIB074
D.3.9.3	Other descriptive name	CNV1014802A
D.3.9.4	EV Substance Code	SUB32074
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	150
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: 2
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	BIIB074
D.3.2	Product code	BIIB074
D.3.4	Pharmaceutical form	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	Raxatrigine (proposed)
D.3.9.1	CAS number	934240-31-0
D.3.9.2	Current sponsor code	BIIB074
D.3.9.3	Other descriptive name	CNV1014802A
D.3.9.4	EV Substance Code	SUB32074
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	200
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	Coated tablet
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

Neuropathic Pain From Lumbosacral Radiculopathy

Neuropathische Pijn door Lumbosacrale Radiculopathie

E.1.1.1

Medical condition in easily understood language

Neuropathic Pain From Lumbosacral Radiculopathy

Neuropathische Pijn door Hernia

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10054095
E.1.2	Term	Neuropathic pain
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10050219
E.1.2	Term	Lumbar radiculopathy
E.1.2	System Organ Class	10029205 - Nervous 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

The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.

Het primaire doel van de studie is om de effectiviteit op neuropathische pijn van 2 doseringregimes van BIIB074 te evalueren bij patiënten met PLSR.

E.2.2

Secondary objectives of the trial

A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life.

Een secundair doel is om de effectiviteit van 2 doseringregimes van BIIB074 op additionele neuropathische pijnmetingen en diagnostiek van lage rugpijn, invaliditeit en kwaliteit van leven te evalueren bij patiënten met PLSR.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening or at the timepoint specified in the individual eligibility criterion listed:

1. Is able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
2. Is aged 18 to 75 years, inclusive, at the time of informed consent.
3. All women of childbearing potential and all men must practice effective contraception during the study and for 5 weeks for women and 14 weeks for men, after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.
4. Has body weight ≥50 kg for men and ≥45 kg for women.
5. Must have diagnosis of neuropathic PLSR with ALL of the following characteristics:
a. Pain perceived in 1 or both legs at areas consistent with the area innervated by the L4, L5, or S1 nerve roots.
b. Evidence of asymmetrical sensory symptoms (hypoesthesia, hyperesthesia, or
allodynia) in the affected areas (typically, the pain may be perceived in the buttock, thigh, calf, foot, or toes).
c. History of pain suggestive that the cause of PLSR is due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues including the intervertebral discs, or secondary to spinal injury and not due to infection/abscess, hematoma, or malignancy.
d. Pain in the legs must be more severe than pain in the back and must be asymmetrical.
6. Has computed tomography (CT) or magnetic resonance imaging (MRI) available that does not show evidence of exclusionary pathology (see exclusion criteria); if not available or has not been conducted within 12 months prior to Screening, MRI must be conducted at Screening. CT is acceptable for subjects with contra-indications for MRI (e.g. metallic implants).
7. Has duration of neuropathic (leg) pain of at least 6 months before Screening.
8. Has stable intensity of neuropathic (leg) pain, with fairly continual pain (but may be worse during rest or at night) for the 4 weeks prior to Screening, based on clinical history.
9. Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Screening and on Day 1 that asks for the average pain intensity of neuropathic (leg) pain due to PLSR over the last week
10. If taking approved concomitant pain medications (i.e., NSAIDs), must be on a stable regimen for at least 4 weeks before Day 1.

Inclusion Criteria: Randomization

To be eligible to be randomized in this study, candidates must meet the following eligibility criteria at the Randomization Visit (Day 15, Week 2):

1. Continues to meet inclusion criteria (above).
2. Has a baseline weekly average daily pain score for neuropathic pain (leg pain) due to PLSR ≥4 and ≤9 on the electronic diary PI-NRS; baseline is defined as the 7 days prior to randomization (nominal Days 8 to 14, with randomization on Day 15).
3. Completed washout of concomitant pain medications except NSAIDs (see Section 7).

Om geschikt te zijn voor deze studie dienen kandidaten aan de volgende geschiktheidscriteria te voldoen bij screening of aan individuele opgesomde criteria op het gespecificeerde tijdstip:

1. Is in staat het doel en de risico's van de studie te begrijpen en getekende en met datum voorziene geïnformeerde toestemming en authorisatie te geven om vertrouwelijke gezondheidsinformatie in overeenstemming met nationale en lokale proefpersoon privacywetten te gebruiken.
2. Is tussen 18 tot en met 75 jaar ten tijde van het geven van toestemming.
3. Alle vruchtbare vrouwen en alle mannen moeten effectieve voorbehoeding toepassen gedurende de studie en voor vrouwen geldt gedurende 5 weken na en mannen 14 weken na de laatste dosis studiebehandeling. Voor verdere details van voorbehoudseisen in deze studie, lees aub sectie 15.5. 4. Heeft een lichaamsgewicht ≥ 50 kg voor mannen en ≥45 kg voor vrouwen.
5. Moet een diagnosis hebben van neuropathische PLSR met ALLE van de volgende karakteristieken: a. Pijn waargenomen in 1 of beide benen in gebieden overeenkomend met het gebied dat geïnnerveerd wordt door de L4, L5 of S1 zenuwwortels. b. Bewijs van a-symmetrische gevoelssymptomen (hypoesthesie, hyperesthesie, of allodynie) in de aangedane gebieden (gewoonlijk kan de pijn worden waargenomen in de bil, dij, kuit, voet of tenen). c. Verleden van pijn erop wijzend dat de oorzaak van pijn het gevolg is van de lumbosacrale zenuwwortel(s) door degeneratieve ziekte van de ruggewervel in het lumbosacrale ruggemerg of hiermee in verband gebrachte zachte weefsels inclusief de intervertrebale schijven of secundair aan ruggemerletsel en niet het gevolg van infectie/abces, hematoom of kwaadaardigheid. d. Pijn in de benen moet ernstiger zijn dan pijn in de rug en dient a-symmetrisch te zijn.
6. Er is een computer tomografie (CT) of magnetische resonantie scan (MRI) aanwezig die geen bewijs van uit te sluiten pathologie laat zien (zie exclusiecriteria); indien niet aanwezig of het werd niet gedaan binnen 12 maanden voor Screening, een MRI moet gedaan worden bij Screening. CT is acceptabel voor proefpersonen met contra-indicaties voor MRI (bv. metalen imlantaten).
7. Er is neuropathische (been)pijn voor de duur van tenminste 6 maanden voor Screening.
8. Heeft een stabiele intensiteit van neuropathische (been)pijn, met tamelijk continue pijn (maar kan 's nachts of in rust erger zijn) gedurende de 4 weken voor Screening, gebaseerd op klinisch verleden.
9. Heeft een intensiteit van ≥4 and ≤9 op de op de Numerical Rating Scale gebaseerd op een vraag op papier tijdens Screening en op Dag 1 die vraagt naar de gemiddelde pijnintensiteit van neuropathische (been)pijn als gevolg van PLSR tijdens de laatste week.
10. Als tegelijkertijd goedgekeurde pijnmedicatie (b.v. NSAID's) wordt genomen, dient deze op een stabiel regime te zijn tenminste 4 weken voor Dag 1.

Inclusiecriteria: Randomisatie

Om geschikt te zijn om gerandomiseerd te worden in deze studie, dienen kandidaten aan de volgende geschiktheidscriteria te voldoen gedurende de Randomisatievisite (Dag 15, Week 2);

1. Blijft aan inclusiecriteria voldoen (boven).
2. Heeft een baseline wekelijks gemiddelde dagelijkse pijnscore voor neuropathische pijn (beenpijn) a.g.v. PLSR ≥4 en ≤9 in het electronisch dagboek PI-NRS; baseline is gedefinieerd als de 7 dagen voor randomisatie (nominale Dagen 8 tot 14, met randomisatie op Dag 15).
3. Gedane uitwassing van gelijktijdig gegeven pijnmedicatie behalve NSAIDs (zie Sectie 7)

E.4

Principal exclusion criteria

Key Exclusion Criteria:
- Has pain of a different type in the legs (e.g. due to arthritis) that may interfere with the assessment of neuropathic pain in the legs.
-Has planned surgical intervention for PLSR within the duration of the study.
- Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
- Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders
- Unable to discontinue prior to Day 1 any prohibited concomitant monoamine oxidase inhibitors (MAOIs), potent CYP3A4 inducers or inhibitors, potent UGT inducers or inhibitors, including over the counter preparations, herbal remedies, vitamin, mineral supplements, food or drinks as detailed in 11.5.1.2
- Is pregnant or lactating (female subjects only).
- Male subject whose partner is pregnant
-Has used paracetamol/acetaminophen at a daily dose of equal to or more than 2.5g/day on 5 or more days during 7 consecutive days in the run in phase.
- Other protocol-defined inclusion/exclusion criteria may apply.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS. Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. *Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening.
*Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening.

De primaire onderzoeksvariabele verwijst naar de verandering van Baseline (Week 2) tot Week 14 in het wekelijks gemiddelde van de dagelijkse neuropathische pijnscore op de 11-punten PI-NRS. Proefpersonen zullen elke avond gevraagd worden hun algehele neuropathische pijn van de laatste 24 uur te beoordelen.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 14 last 24-hour period.

Week 14 last 24-uurs periode.

E.5.2

Secondary end point(s)

Efficacy endpoints in neuropathic pain:
1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a
response is defined as a ≥50% reduction in the weekly average of the daily
neuropathic pain score from Baseline (Week 2) to Week 14
2. 30% neuropathic daily pain reduction response (yes/no) at Week 14, where a
response is defined as a ≥30% reduction in the weekly average of the daily
neuropathic pain score from Baseline (Week 2) to Week 14
3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic
pain score at each visit
Efficacy endpoint in low back pain:
4. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily
pain score for low back pain; subjects will be asked every evening to rate their
overall low back pain for the last 24-hour period
Other efficacy endpoints:
5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14,
where a responder is defined as either “much improved” or “very much
improved”
6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index
7. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily
sleep score; subjects will be asked every morning to rate on the 11-point Sleep
Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality
8.Change from Baseline (Week 2) to Week 14 in the Brief Pain Inventory (BPI)-
Interference index
9. Change from Baseline (Week 2) to Week 14 in the BPI-Pain index
10. Change from Baseline (Week 2) to Week 14 on the EuroQoL 5-Dimension
5-Level Questionnaire (EQ-5D-5L) health index
11. Change from Baseline (Week 2) to Week 14 in the Short Form 36 Questionnaire
(SF-36)
12. Amount of rescue medication used (dosage/day)
Another secondary objective is to investigate the safety and tolerability of 2 dose regimens of BIIB074.
The endpoints that relate to this objective are as follows:
 AEs and SAEs
 Vital signs
 ECG parameters
 Laboratory safety tests
 Columbia-Suicide Severity Rating Scale (C-SSRS)
Another secondary objective is to characterize the PK of BIIB074 in this population.

Onderzoeksvariabele betreffende effectiviteit: 1. 50% neuropathische dagelijkse pijn reductierespons (ja/nee) op Week 14, waarbij een respons is gedefinieerd als een ≥50% reductie in het wekelijkse gemiddelde van de dagelijkse neuropathische pijnscore van Baseline (Week 2) tot Week 14 2. 30% neuropathische dagelijkse pijn reductierespons (ja/nee) op Week 14, waarbij een respons is gedefinieerd als een ≥30% reductie in het wekelijkse gemiddelde van de dagelijkse neuropathische pijnscore van Baseline (Week 2) tot Week 14 3. Veranderingen van Baseline (Week 2) in het wekelijks gemiddelde van de dagelijkse neuropathische pijnscore bij elke visite Onderzoeksvariabele betreffende effectiviteit bij lage rugpijn: 4. Verandering van Baseline (Week 2) tot Week 14 in het wekelijkse gemiddelde van de dagelijkse pijnscore voor lage rugpijn; proefpersonen zullen elke avond gevraagd worden om hun algehele lage rugpijnvan de laatste 24 uur te scoren. Andere effectiviteit onderzoeksvariabelen: 5. Patient Global Impression of Change (PGIC) succes (ja/nee) op Week 14, waarbij succes gedefinieerd is als ofwel "veel verbeterd" of "erg veel verbeterd" 6. Verandering t.o.v. Baseline (Week 2) tot Week 14 op de Oswestry Disability Index 7. Verandering t.o.v. Baseline (Week 2) tot Week 14 in het wekelijkse gemiddelde van de dagelijkse slaapscore; proefpersonen zullen elke morgen worden gevraagd om op de 11-punten Sleep Numerical Scale (S-NRS) te scoren hoe beenpijn interfereerde met hun slaapkwaliteit 8. Verandering t.o.v. Baseline (Week 2) tot Week 14 op de Brief Pain Inventory (BPI)-Interference index 9. Verandering t.o.v. Baseline (Week 2) tot Week 14 op de BPI-Pain index 10. Verandering t.o.v. Baseline (Week 2) tot Week 14 op de EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index 11. Verandering t.o.v. Baseline (Week 2) tot Week 14 op de Short Form 36 Vragenlijst (SF-36) 12. De gebruikte hoeveelheid noodmedicatie (dosering/dag) Een andere secundair doel is om de veiligheid en tolerantie van 2 dosis regimes te onderzoeken van BIIB074. De onderzoeksvariabelen die aan dit doel raken zijn als volgt: AEs en SAEs Vitale functies ECG parameters Laboratorim veiligheids tests Columbia-Suicide Severity Rating Scale (C-SSRS) Een andere secundair doel is om de PK van BIIB074 bij deze populatie te karakteriseren.

E.5.2.1

Timepoint(s) of evaluation of this end point

Points 1; 2; 6 - Week 14
Point 3 - Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit.
Point 4-11 -Change from Baseline (Week 2) to Week 14

Punten 1-2; 4-12 - Week 14 .
Punt 3 - Veranderingen t.o.v. Baseline (Week 2) in het wekelijks gemiddelde van de dagelijkse neuropathische pijnscore bij elke visite.
Punten 4-11 - Verandering t.o.v. Baseline (Week 2) tot Week 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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Verdraagbaarheid

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

Austria

Belgium

Bulgaria

Czech Republic

France

Georgia

Italy

Latvia

Netherlands

Romania

Serbia

Slovakia

Spain

United Kingdom

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

LVLP

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

104

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

434

F.4.2.2

In the whole clinical trial

504

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)

Eligible subjects may continue into the extension study, Study 1014802-204.

Geschikte proefpersonen mogen verdergaan in de vervolgstudie, studie 1014802.

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

2016-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-08-06

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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