Clinical Trials Register

Summary
EudraCT Number:	2013-002952-34
Sponsor's Protocol Code Number:	ACH-UCP-301
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:	2021-01-07
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

2013-002952-34

A.3

Full title of the trial

A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic,
Antibiotic Refractory Primary Idiopathic Pouchitis

Studio randomizzato, in doppio cieco, controllato con placebo, multicentrico sulla sicurezza e l'efficacia del trattamento topico con alicaforsen clistere in soggetti affetti da pouchite idiopatica primaria, attiva, cronica e refrattaria agli antibiotici

A.3.1

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

Evaluation of the Safety and Efficacy of Alicaforsen Enema compared to placebo in patients with Active, Chronic, Primary Idiopathic Pouchitis which cannot be treated efficiently with antibiotics

Valutazioone della sicurezza ed efficacia di Alicaforsen clistere confrontata con placebo in pazienti affetti da pouchite idiopatica primaria, attiva, cronica e refrattaria agli antibiotici

A.3.2

Name or abbreviated title of the trial where available

ACH-UCP-301

A.4.1

Sponsor's protocol code number

ACH-UCP-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02525523

A.5.4

Other Identifiers

Name:

ACH-UCP-301

Number:

ACH-UCP-301

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	ATLANTIC 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	Atlantic Pharmaceutical 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	Atlantic Pharmaceuticals Limited
B.5.2	Functional name of contact point	Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Atlantic House;12 Rose & Crown Walk
B.5.3.2	Town/ city	Saffron Walden, Essex
B.5.3.3	Post code	CB101JH
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441799513391
B.5.5	Fax number	0
B.5.6	E-mail	chris@atlantichc.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/641
D.3 Description of the IMP
D.3.1	Product name	Alicaforsen
D.3.2	Product code	ISIS2302
D.3.4	Pharmaceutical form	Rectal solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	alicaforsen
D.3.9.1	CAS number	331257-52-4
D.3.9.2	Current sponsor code	ISIS2302
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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	Rectal solution
D.8.4	Route of administration of the placebo	Rectal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

Trattamento della pouchite cronica, refrattaria agli antibiotici

E.1.1.1

Medical condition in easily understood language

Patients affected by Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

Soggetti affetti da pouchite refrattaria cronica agli antibiotici

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

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	10036463
E.1.2	Term	Pouchitis
E.1.2	System Organ Class	10017947 - Gastrointestinal 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

To determine the effect of alicaforsen enema on endoscopic healing and symptoms associated with pouchitis in those subjects with active antibiotic refractory pouchitis

Determinare l'effetto di alicaforsen clistere sulla guarigione visibile endoscopicamente e sui sintomi associati alla pouchite in soggetti affetti da pouchite attiva refrattaria agli antibiotici

E.2.2

Secondary objectives of the trial

1. To determine the ability of alicaforsen enema to improve the clinical
symptoms associated with antibiotic refractory pouchitis
2. To determine the effect of alicaforsen enema on health related quality
of life.
3. To evaluate duration of effect following cessation of therapy

1.Determinare la capacit¿ di alicaforsen clistere di migliorare i sintomi clinici associati alla pouchite refrattaria agli antibiotici.
2.Determinare gli effetti di alicaforsen clistere sulla qualit¿ di vita correlata alla salute.
3.Valutare la durata dell'effetto dopo la cessazione della terapia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent;
2. Male or female subjects, 18 years of age who have undergone an IPAA for UC
3. History of pouchitis
Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
4. Endoscopic score = 2 on the endoscopic component of a modified MAYO score (where friability is scored as = 2) Note: the area within 1 cm of the pouch staple, or pouch suture line, is
not considered evaluable
5. Symptomatic disease (stool frequency): Subjects must demonstrate increased stool frequency compared to what is considered "normal"
after their IPAA operation ("baseline"). Stool frequency must be an absolute value of = 6 stools per day, and = 3 stools per day above the
post-IPAA "baseline". Note: The measurement of stool frequency will be a 7-day average
rounded to the nearest integer. The most recent 7 days of data will be used to calculate the average.
6. Histology: evidence of disease (Score = 2 on PDAI)
7. Overall PDAI score > 7
8. Must have Chronic Antibiotic Refractory Pouchitis
Chronic Antibiotic Refractory Pouchitis is defined as remaining in active disease despite antibiotic therapy for at least 2 continuous weeks. There
is no requirement for antibiotic use to be current, or within a defined time-window. Antibiotics must be stopped 4 weeks before the Randomizaton visit which is effectively 2 weeks before the screening visit. As a minimum the antibiotic regime will comprise ciprofloxacin 1g/day, or metronidazole 15 – 20 mg/kg/day. Patients must have been
in active disease for a minimum of 4 weeks at the point of randomisation.

1.Consenso informato scritto.
2.Soggetti di ambo i sessi, di età ¿18 anni e sottoposti ad anastomosi ileale-pouch-anale (IPAA, Ileal Pouch-Anal Anastomosis) per colite ulcerosa (CU).
3.Storia della pouchite
Evidenza documentata di pouchite attiva, basata su endoscopia, sintomi e istopatologia, con le seguenti caratteristiche:
4.Punteggio endoscopico >=2 nella componente endoscopica del punteggio MAYO modificato (dove alla friabilità è attribuito un punteggio >=2).
Nota: l’area compresa entro 1 cm dalla clip metallica della pouch, o dalla linea di sutura della pouch, non è considerata valutabile.
5.Malattia sintomatica (frequenza di evacuazione): I soggetti devono dimostrare una frequenza di evacuazione superiore rispetto a quanto ritenuto "normale" dopo l'operazione IPAA (il "basale"). La frequenza di evacuazione deve avere un valore assoluto di >=6 episodi al giorno e >=3 episodi al giorno sopra il valore basale post-IPAA.
Nota: la misurazione della frequenza di evacuazione dovrà essere una media di 7 giorni arrotondata al più vicino numero intero. Per calcolare la media dovranno essere usati i 7 giorni di dati più recenti.
6.Istologia: evidenza di malattia (punteggio PDAI >=2).
7.Punteggio PDAI complessivo >7.
8.Deve essere presente una pouchite cronica refrattaria agli antibiotici
Si definisce cronica e refrattaria agli antibiotici una pouchite che rimane attiva malgrado una terapia antibiotica protratta per almeno 2 settimane consecutive. Non è necessario che la terapia antibiotica sia ancora in atto, oppure che rientri in una determinata finestra temporale. Gli antibiotici devono essere stati interrotti 4 settimane prima della Visita di randomizzazione che è effettivamente 2 settimane prima della visita di screening. Il regime antibiotico deve essere consistito almeno in ciprofloxacina 1 g/die o metronidazolo 15–20 mg/kg/die. I pazienti devono essere in uno stato di malattia attiva da almeno 4 settimane al momento della randomizzazione.

E.4

Principal exclusion criteria

1. Lack of effective contraception
2. Women who are pregnant or breastfeeding;
3. History of allergy or adverse event to oligonucleotides including alicaforsen hidroxymethylcellulose, methyl
or propylparabens.
4. Change in dose to strong analgesia, such as opioid containing compounds within 4 weeks of the screening visit.
5. History of regular NSAID use.
6. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who have discontinued or changed doses of oral 5-ASA within 4 weeks of the
Screening Visit.
7. Oral budesonide > 6.0 mg / day is not permitted; exclude subjects who have received budesonide for < 6 weeks, or who have changed doses of budesonide within 4 weeks of the Screening Visit.
8. Oral steroids other than budesonide; exclude subjects who exceed a daily dose of 15 mg prednisolone or equivalent, who have received oral
steroids for < 6 weeks, or who have changed dose within 4 weeks of the Screening Visit.
9. Use of rectal compounds is not permitted; these agents must be discontinued at the Screening Visit.
10. Immunosuppressant therapy (azathioprine, 6-mercaptopurine, methotrexate, cyclosporin); exclude subjects who have received treatment for < 12 weeks, or who have changed doses within 8 weeks of the Screening Visit.
11. Biological agents: Anti-tumour necrosis factor (anti – TNF) therapyand / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
12. Previous use of alicaforsen is permitted: treatment course must have completed at least 12 weeks prior to the Screening Visit. (Alicaforsen
pre-treated subjects may not contribute to the primary efficacy analysis.)
13. All other agents targeted to pouchitis, including experimental agents,must have been discontinued at least 8 weeks prior to the Screening
Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer)
14. Anastomotic stricture
15. Unable to undertake endoscopic evaluation
16. Faecal incontinence due to anal sphincter dysfunction
17. Infections to cytomegalovirus or Clostridium Difficile
18. Faecal transplantation within 12 weeks of screening.
19. Intestinal malabsorption
20. Pancreatic maldigestion
21. Suspected irritable pouch syndrome
22. Cuffitis (inflammation of the anal mucosa).
Subjects with active antibiotic refractory pouchitis as the predominant condition, but who also have cuffitis, may be enrolled
23. Crohn's disease of the pouch: defined as either:a)complex perianal or pouch fistula and/or b) extensive pre-pouch ileitis with deep ulceration.
24. Subjects with a history of neoplastic disease except for basal cellcarcinoma or non-metastatic squamous cell carcinoma of the skin
25. Subjects who are receiving or have received nasogastric/nasoenteric bottle feeding, an elemental diet, or total parenteral nutrition within the 2 weeks prior to Day 1
26. Subjects with a history of clinically significant and/or persistent hhaematologic, renal hepatic, metabolic, psychiatric, CNS, pulmonary or cardiovascular disease; which in the investigators opinion, would exclude entry into the study
27. Subjects with any laboratory tests considered clinically significant at screening
28. Subjects who may be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by
the Investigator for any other reason including, for example, inability to retain an enema formulation
29. Pelvic sepsis should be excluded as a differential diagnosis, within 12 months of randomization.

1.Assenza di misure contraccettive efficaci.
2.Donne in stato di gravidanza o in fase di allattamento.
3.Storia di allergia o evento avverso agli oligonucleotidi incluso alicaforsen idrossimetilcellulosa, al metile o ai propilparabeni.
4. Cambiamenti nelle dosi di farmaci per forte analgesia, ad esempio con composti a base di oppioidi, entro 4 settimane dalla Visita di screening.
5.Storia di regolare utilizzo di FANS.
6.Composti orali a base di 5-aminosalicilati (5 ASA); sono esclusi i pazienti che hanno interrotto o modificato il dosaggio dei 5-ASA orali nelle 4 settimane precedenti la Visita di screening.
7.L'uso di budesonide orale a una dose >6,0 mg/die non è consentito; sono esclusi i soggetti in terapia con budesonide da meno di 6 settimane, o che hanno modificato il dosaggio di budesonide nelle 4 settimane precedenti la Visita di screening.
8.Steroidi orali, diversi dalla budesonide; sono esclusi i soggetti che superano una dose giornaliera di 15 mg di prednisolone o equivalente, che sono in terapia con steroidi orali da meno di 6 settimane o che hanno modificato il dosaggio nelle 4 settimane precedenti la Visita di screening.
9.L'uso di composti per uso rettale non è consentito; tali agenti possono essere interrotti alla Visita di screening.
10.Terapia immunosoppressiva (azatioprina, 6-mercaptopurina; metotressato, ciclosporina); sono esclusi i pazienti in terapia da meno di 12 settimane, o che hanno modificato il dosaggio nelle 8 settimane precedenti la Visita di screening.
11.Agenti biologici: La terapia anti-fattore di necrosi tumorale (anti-TNF) e/o con vedolizumab non è consentita nelle 8 settimane precedenti la Visita di screening.
12.È consentito l'uso precedente di alicaforsen: il ciclo di trattamento deve essere stato completato almeno 12 settimane prima della Visita di screening. (I soggetti pretrattati con alicaforsen non possono essere inseriti nell'analisi di efficacia primaria.)
13.Tutti gli altri agenti per il trattamento della pouchite, compresi gli agenti sperimentali, devono essere stati interrotti almeno 8 settimane prima della Visita di screening, oppure da un periodo equivalente a 5 emivite (t½) dell'agente (il periodo più lungo tra i due).
14.Stenosi anastomotica
15.Incapacità di sottoporsi alla valutazione endoscopica.
16.Incontinenza fecale dovuta a disfunzione dello sfintere anale
17.Infezioni da citomegalovirus o da Clostridium Difficile
18.Trapianto fecale entro le 12 settimane dallo Screening
19.Malassorbimento intestinale
20.Maldigestione a causa pancreatica
21.Sospetta sindrome di pouch irritabile
22.Cuffite (infiammazione della mucosa anale). I soggetti affetti da pouchite attiva refrattaria agli antibiotici come patologia predominante, ma con la compresenza di cuffite, possono essere arruolati
23.Morbo di Crohn a carico della pouch; definito come: a) complessa fistola o pouch perianale e/o b) ileite estesa pre-pouch con profonda ulcerazione
24.Soggetti con una storia di neoplasia, eccetto carcinoma a cellule basali o carcinoma a cellule squamose della cute non metastatico
25.Soggetti sottoposti, attualmente o in passato, ad alimentazione con sondino nasogastrico/nasoenterico, o sottoposti a un'alimentazione elementare o a nutrizione parenterale totale nelle 2 settimane precedenti il Giorno 1
26.Soggetti con antecedenti malattie clinicamente significative e/o persistenti, ematologiche, renali epatiche metaboliche, psichiatriche, CNS, polmonari, cardiovascolari, che secondo il parere dello sperimentatore precludono l'inclusione nello studio
27.Soggetti con valori degli esami di laboratorio ritenuti clinicamente significativi allo screening
28.Soggetti che potrebbero non essere disponibili per l'intera durata dello studio, che probabilmente non rispetterebbero il protocollo, o che lo sperimentatore ritiene non idonei per qualsiasi altra ragione, tra cui ad esempio incapacità di trattenere la formulazione in clistere.
29.La sepsi pelvica deve essere esclusa mediante diagnosi differenziale entro le 12 settimane dalla randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

Co-Primary Endpoints:
1. Proportion of subjects with endoscopic remission; defined as absence
of friability and ulceration, represented by a score of = 1 (endoscopy
component of a modified MAYO score) at Week 10.
Note : the area within 1 cm of the pouch suture line will not be included in the endoscopic evaluation.
2. Proportion of subjects with a stool frequency represented by a MAYO
subscore of = 1 at Week 10
Timepoint(s) of evaluation of this end point

Endpoint co-primary_
1.Percetuali di soggetti con remissione endoscopica definita come assenza di firabilità e ulcerazione, rappresentate da un punteggio <=1 (componente endoscopica di un punteggio MAYO modificato) alla settimana 10 Nota: l'area entro 1 cm dalla linea di sutura della pouch non sarà inclusa nella valutazione endoscopica.
2. Percentuale di soggetti con una frequenza di evaucuazioni rappresentata da un punteggio MAYO <= 1 alla settimana 10

E.5.1.1

Timepoint(s) of evaluation of this end point

10 weeks

10 settimane

E.5.2

Secondary end point(s)

1. Percentage change in stool frequency from baseline compared to placebo; Week 6 and Week 10.
2. Change in urgency score from baseline compared to placebo; Week 6.
3. Change in rectal bleeding score from baseline compared to placebo; Week 6.
4. Proportion of subjects who achieve overall PDAI <5 at both Week 6 and Week 10.
5. Mean change from baseline in CGQL at Week 6. 6. Proportion of subjects by Week 26, who have not received additional treatment for pouchitis flares, since commencing study.

1.Variazione percentuale dal basale della frequenza di evacuazione rispetto al placebo; settimane 6 e 10. 2.Variazione percentuale dal basale del punteggio relativo all'urgenza rispetto al placebo; Settimana 6 3.Variazione del punteggio relativo a sanguinamento rettale dal basale rispetto al placebo alla settimana 6.
4. Percentuale di soggetti che conseguono un punteggio PDAI complessivo <5 sia alla settimana 6 che alla Settimana 10
5.Variazione media dal basale del punteggio CGQL alla Settimana 6
6. Percentuale di soggetti che alla settimana 26 non hanno ricevuto un trattamento di ¿Salvataggio" per riacutizzazione di pouchite dall'inizio dello studio

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 6, 10, 26

Settimana 6, 10 e 26

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

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

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

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

Canada

Israel

United States

Belgium

France

Ireland

Italy

Netherlands

Switzerland

United Kingdom

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.1.1.1

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

138

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)

Expected normal treatment of that condition.
In addition, participation in an open-label program will be offered to patients who completed the study, reached at least Week 10 of the study and have symptomatic pouchitis.

Trattamento in accordo alla pratica clinica per tale condizione.
Inoltre, a tutti coloro che avranno terminato lo studio al raggiungimento almeno della settimana 10, e che dimostrano di avere una pouchite sintomatica, verr¿ offerta la possibilit¿ di partecipare ad un porgramma in aperto.

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

2016-01-12

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	2019-03-25

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