Clinical Trials Register

Summary
EudraCT Number:	2015-002581-23
Sponsor's Protocol Code Number:	JBT101-CF-001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-20
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-002581-23

A.3

Full title of the trial

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis

Studio multicentrico di fase II, in doppio cieco, randomizzato, controllato con placebo per valutare sicurezza, tollerabilità, farmacocinetica ed efficacia di JBT-101 nella fibrosi cistica

A.3.1

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

A study on safety and efficacy of JBT-101 in cystic fibrosis.

Uno studio sulla sicurezza e efficacia di JBT-101 nella fibrosi cistica.

A.3.2

Name or abbreviated title of the trial where available

JBT101 in cystic fibrosis

JBT101 nella fibrosi cistica

A.4.1

Sponsor's protocol code number

JBT101-CF-001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02465450

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	CORBUS PHARMACEUTICALS, INC
B.1.3.4	Country	United States
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	Corbus Pharmaceuticals, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	TMC Pharma Services Ltd
B.5.2	Functional name of contact point	Clinical Research
B.5.3	Address:
B.5.3.1	Street Address	Lodge Farm Barn, Elvetham Park Estate, Fleet Rd
B.5.3.2	Town/ city	Harley Wintney
B.5.3.3	Post code	RG278AS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441252842255
B.5.5	Fax number	00441252842277
B.5.6	E-mail	nicola.kidman@tmcpharma.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	JBT101
D.3.2	Product code	JBT101
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	137945-48-3
D.3.9.2	Current sponsor code	JBT101
D.3.9.4	EV Substance Code	SBB178399
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	1
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	JBT101
D.3.2	Product code	JBT101
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	137945-48-3
D.3.9.2	Current sponsor code	JBT101
D.3.9.4	EV Substance Code	SUB178399
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	JBT101
D.3.2	Product code	JBT101
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	137945-48-3
D.3.9.2	Current sponsor code	JBT101
D.3.9.4	EV Substance Code	SUB178399
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Cystic fibrosis

Fibrosi cistica

E.1.1.1

Medical condition in easily understood language

Cystic fibrosis

Fibrosi cistica

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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	10011762
E.1.2	Term	Cystic fibrosis
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the safety [vital signs, physical
examination, adverse events, blood and urine laboratory safety tests, QT/QTc intervals, and psychotrophic activity] and tolerability of JBT-101 in subjects with cystic fibrosis.

Valutare la sicurezza (PA, esame clinico, eventi avversi, test di laboratorio basali, intervalli QT/QTc e
attività psicotropica) e la tollerabilità di JBT-101 in soggetti con fibrosi cistica.

E.2.2

Secondary objectives of the trial

Evaluate JBT-101 plasma concentrations and metabolites in cystic fibrosis; Evaluate efficacy of JBT-101 in cystic fibrosis, measuring changes from baseline and trends for efficacy in forced expiratory volume in one
second, Lung Clearance Index (optional by site), and Cystic Fibrosis Questionnaire - Revised Respiratory Symptoms score in subjects with cystic fibrosis.

Valutare JBT-101 per le concentrazioni plasmatiche e i metaboliti in soggetti con fibrosi cistica. Valutare l'efficacia di JBT-101 negli stessi soggetti, misurando le variazioni dal baseline e i trends per l'efficacia nei parametri: FEV1, Lung Clearance Index (opzionale), e questionario per la FC - Revised Respiratory Symptoms score.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Documented diagnosis of cystic fibrosis
+
1. =18 and < 65 years of age at the time the Informed Consent Form is signed
2. FEV1 = 40% predicted, either pre- or post bronchodilator.
3. Stable treatment of cystic fibrosis for 14 days before Visit 1.

1. Diagnosi documentata di fibrosi cistica.
+
1. = 18 e < 65 anni di età al momento della firma del Modulo di consenso informato
2. FEV1 = 40% del valore previsto
3. Trattamento stabile della FC per 14 giorni prima della Visita 1.

E.4

Principal exclusion criteria

1. Severe or unstable cystic fibrosis.
2. Any of the following values for laboratory tests at Screening
a. A positive pregnancy test (also Visit 1)
b. Hemoglobin < 10 g/dL
c. Neutrophils < 1.0 x 109/L
d. Platelets < 500 cells/µL
e. Creatinine clearance < 50 ml/min according to modified Cockcroft- Gault equation;
f. Serum transaminases > 2.5 x upper normal limit
g. Total bilirubin = 1.5 x upper limit of normal

1. FC grave o instabile, come:
a. Trattamento antibiotico endovenoso nei 14 giorni precedenti la Visita 1
b. Trattamento con corticosteroidi > 10 mg al giorno o con prednisone per via orale (o equivalente)
> 20 mg a giorni alterni nei 14 giorni precedenti la Visita 1
2. Uno dei seguenti valori nelle analisi di laboratorio in fase di screening:
a. Test di gravidanza positivo (anche alla Visita 1)
b. Emoglobina < 10 g/dl
c. Neutrofili < 1,0 x 109/l
d. Piastrine < 500 cellule/µl
e. Clearance della creatinina < 50 ml/min secondo l'equazione di Cockcroft-Gault modificata;
f. Transaminasi sieriche > 2,5 volte il limite superiore della norma
g. Bilirubina totale > 1,5 volte il limite superiore della norma

E.5 End points

E.5.1

Primary end point(s)

Safety and tolerability, comparing all
subjects who received JBT-101 at any time during the trial to subjects who received placebo throughout the trial. • Safety will be assessed by percentage and number of subjects who experience treatment-emergent adverse events, including serious adverse events. Adverse events will be identified through verbal reports by the subject and clinical assessment of vital signs, physical
examination, laboratory safety tests, electrocardiograms including QT/QTc intervals, and Addiction Research Center inventoryMarijuana scale. • Tolerability will be assessed by the number and proportion of subjects that withdraw from the trial during the treatment period because of treatment-related adverse events

Sicurezza e tollerabilità comparando tutti i soggetti che abbiano ricevuto JBT101 durante lo studio
con i soggetti che hanno ricevuto placebo. La sicurezza sarà valutata come percentuale e numero di soggetti che abbiano avuto eventi avversi dal trattamento, inclusi quelli gravi. Gli EA saranno identificati dai rapporti dei pazienti e la loro valutazione clinica e diagnostica (ECG, laboratorio) e inoltre con la scala Addiction Research Center Inventory-Marijuana. La tollerabilità saràa valutata sul numero e la percentuale di soggetti che si ritirano dalla sperimentazione durante il periodo di trattamento a causa di EA associati al trattamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety will be assessed from baseline on Day 1 (Visit 1) prior to study product administration through 28 +/- 3 days after the last dose of study product (Day 113 +/- 3, Visit 7). Subject-reported adverse events and vital signs will be collected at every visit. The other clinical assessment will be done at various visits. In addition, non-treatment related adverse events will be captured from the screening up to the first dose of study product. •Tolerability will be assessed from the first dose of study product (Day 1, Visit 1) through the end of active treatment (Day 85 +/- 3, Visit 6), with an 84 day active treatment period planned.

Sicurezza sarà valutata dal basale al giorno 1 (Visita 1) prima della somministrazione del prodotto, a 28 +/- 3 giorni e dopo l'ultima dose di Prodotto studio (giorno 113 +/- 3, Visita 7). - Gli avversi eventi riferiti dal soggetto e i segni vitali saranno raccolti ad ogni visita. L'altra valutazione clinica sarà effettuata a ogni visita. Inoltre, eventi avversi non correlati al trattamento saranno catturati dallo screening fino alla prima dose di prodotto. • La tollerabilità sarà valutata dalla prima dose di prodotto studio (1 ° giorno, Visita 1) fino alla fine del trattamento attivo (Giorno 85 +/- 3, Visita 6), con un periodo di trattamento attivo di 84 giorni.

E.5.2

Secondary end point(s)

Levels of JBT-101 and its metabolites in plasma, in all subjects who received JBT-101 during the trial; Change in FEV1, percent predicted and absolute value, comparing all subjects who received JBT-101 at any time during the trial to subjects who received placebo throughout the trial; Change in lung clearance index, comparing all subjects who received JBT-101 at any time during the trial to subjects who received placebo throughout the trial; Cystic Fibrosis Questionnaire–Revised Respiratory Symptom Score, comparing all subjects who received JBT-101 at any time during the trial to subjects who received placebo throughout the trial

Livelli di JBT-101 e dei suoi metaboliti nel plasma, in tutti i soggetti che hanno ricevuto JBT-101 durante lo studio.; Variazione della FEV1, percentuale prevista e valore assoluto, si confrontano tutti i soggetti che hanno ricevuto JBT-101 in qualsiasi momento durante lo sudio con i soggetti che hanno ricevuto placebo.; Variazione dell'indice clearance polmonare, confrontando tutti i soggetti che hanno ricevuto JBT -101 in qualsiasi momento durante lo studio con i soggetti che hanno ricevuto il placebo.; Fibrosi Cistica Questionnaire-Revised Respiratory Symptom Score, confrontando tutti i soggetti che hanno ricevuto JBT-101 in qualsiasi momento durante lo studio con i soggetti che hanno ricevuto placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

Prior to study product administration (Day 1, Visit 1), 3 hours after study product administration on Day 1, Day 15 +/- 3 (Visit 2), Day 29 +/- 3 (Visit 3) both prior to study product administration and 3 hours after study product administration, Day 43 +/- 3 (Visit 4), and Day 85 +/- 3 (Visit 6, end of active treatment); prior to study product administration through Day 85 +/- 3 (Visit 6, end of active treatment); Day 1 (Visit 1) prior to study product administration through Day 85 +/- 3 (Visit 6, end of active treatment); Day 1 (Visit 1) prior to study product administration through Day 85 +/- 3 (Visit 6, end of active treatment)

Prima della somministrazione del prodotto (1 ° giorno, Visita 1), 3 ore dopo la somministrazione del prodotto studio al giorno 1, Giorno 15 +/- 3 (Visita 2), giorno 29 +/- 3 (Visita 3) sia prima amministrazione studio del prodotto e 3 ore dopo la somministrazione del prodotto studio, Giorno 43 +/- 3 (Visita 4), e il giorno 85 +/- 3 (Visita 6, fine del trattamento attivo); 1 ° giorno (Visita 1) prima di studiare amministrazione del prodotto attraverso Giorno 85 +/- 3 (Visita 6, fine del trattamento attivo; 1 ° giorno (Visita 1) prima della somministrazione del prodotto attraverso Giorno 85 +/- 3 (Visita 6, fine del trattamento attivo); Giorno 1 (Visita 1) prima della somministrazione del prodotto attraverso Giorno 85 +/- 3 (Visita 6, fine del trattamento attivo)

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

Yes

E.8.1.7.1

Other trial design description

clude una dose escalation per JBT-101, e un passaggio di 10 soggetti da placebo a JBT-101

Includes dose escalation on JBT-101 and switching 10 placebo subjects to JBT-101

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

Information not present in EudraCT

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

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

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:

F.1.3

Elderly (>=65 years)

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)

When the trial is over, subjects will continue to receive care for cystic
fibrosis by their treating physician. Subjects will remain on their baseline treatment for cystic fibrosis during the trial, to reduce risk of disease flare where study product is discontinued.

Quando il trial è completato i soggetti continueranno a ricevere cura per la fibrosi cistica dal medico curante. I soggetti manterranno il loro trattamento per la fibrosi cistica durante il trial, per ridurre i rischi di esacerbazione della malattia quando il prodotto in studio sia interrotto.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	European Cystic Fibrosis Society Clinical Trials Network
G.4.3.4	Network Country	Denmark
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Cystic Fibrosis Foundation Therapeutics
G.4.3.4	Network Country	United States

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-04-10

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