Clinical Trials Register

Summary
EudraCT Number:	2022-000719-30
Sponsor's Protocol Code Number:	GLPG0634-CL-341
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:	2022-09-14
Trial 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

2022-000719-30

A.3

Full title of the trial

A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered filgotinib in subjects with ulcerative colitis in clinical remission

Studio multicentrico, controllato, randomizzato, in doppio cieco volto a valutare l’efficacia e la sicurezza della riduzione della dose di filgotinib somministrato per via orale in soggetti con colite ulcerosa in remissione clinica

A.3.1

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

A study evaluating the effect of filgotinib dose de-escalation in patients with ulcerative colitis in remission

Studio per valutare l’effetto della riduzione della dose di filgotinib in pazienti con colite ulcerosa in remissione

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

GLPG0634-CL-341

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	GALAPAGOS NV
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	Galapagos NV
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	Galapagos NV
B.5.2	Functional name of contact point	Galapagos Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Generaal de Wittelaan L11 A3
B.5.3.2	Town/ city	Mechelen
B.5.3.3	Post code	2800
B.5.3.4	Country	Belgium
B.5.6	E-mail	medicalinfo@glpg.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	Yes
D.2.1.1.1	Trade name	Jyseleca
D.2.1.1.2	Name of the Marketing Authorisation holder	Galapagos NV
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.3.1	Product name	Filgotinib
D.3.2	Product code	[GLPG0634]
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	Filgotinib
D.3.9.2	Current sponsor code	GLPG0634
D.3.9.3	Other descriptive name	Jyseleca
D.3.9.4	EV Substance Code	SUB182273
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	100
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	Yes
D.2.1.1.1	Trade name	Jyseleca
D.2.1.1.2	Name of the Marketing Authorisation holder	Galapagos NV
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.3.1	Product name	Filgotinib
D.3.2	Product code	[GLPG0634]
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	Filgotinib
D.3.9.2	Current sponsor code	GLPG0634
D.3.9.3	Other descriptive name	Jyseleca
D.3.9.4	EV Substance Code	SUB182273
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	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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-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

Ulcerative colitis (UC)

Colite ulcerosa (CU)

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

Colite ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of filgotinib in subjects in stable clinical remission on 200 mg filgotinib once daily (q.d.) for whom the dose was decreased to 100 mg q.d. compared to subjects remaining on 200 mg q.d.

Valutare l’efficacia di filgotinib in soggetti in remissione clinica stabile trattati con 200 mg di filgotinib una volta al giorno (QD) per i quali la dose è stata ridotta a 100 mg QD rispetto ai soggetti che sono rimasti in trattamento con 200 mg QD.

E.2.2

Secondary objectives of the trial

- To evaluate the effect of dose de-escalation of filgotinib on time to flare.
- To evaluate the effect of dose de-escalation of filgotinib on disease-specific biomarkers and Inflammatory Bowel Disease Questionnaire.
- To evaluate the safety and tolerability of filgotinib.

- Valutare l’effetto della riduzione della dose di filgotinib sul tempo alla riacutizzazione.
- Valutare l’effetto della riduzione della dose di filgotinib sui biomarcatori specifici della malattia e sul Questionario sulla malattia infiammatoria intestinale (IBDQ).
- Valutare la sicurezza e la tollerabilità di filgotinib.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects must be participating in the SELECTION-LTE study, currently on 200 mg filgotinib q.d. and fulfill the following conditions:
• pMCS remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study prior to and including screening of the present study;
• free of corticosteroids for at least 12 weeks prior to and including baseline;
• FCP <=250 µg/g at last observation;
• sigmoidoscopy ES of 0 or 1 (local score) at screening.
- Female subjects of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during filgotinib treatment.
- Male subjects and female subjects of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
- Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of filgotinib in the study.

This list only contains the key inclusion criteria.

- I soggetti devono star partecipando allo studio SELECTION-LTE, attualmente in terapia con 200 mg di filgotinib QD e soddisfare le seguenti condizioni:
• remissione pMCS nell’arco di un periodo di almeno 2 visite trimestrali consecutive nello studio SELECTION-LTE prima del e incluso lo screening del presente studio;
• assenza di corticosteroidi per almeno 12 settimane prima del basale incluso;
• FCP <=250 µg/g all’ultima osservazione;
• sigmoidoscopia ES di 0 o 1 (punteggio locale) allo screening.
- I soggetti di sesso femminile in età fertile devono presentare un test di gravidanza altamente sensibile (gonadotropina corionica umana beta sierica) negativo durante lo screening e devono accettare di proseguire con i test di gravidanza urinari con striscia reattiva a cadenza mensile durante il trattamento con filgotinib.
- I soggetti di sesso maschile e femminile in età fertile devono accettare di utilizzare misure contraccettive altamente efficaci come definito nel protocollo.
- Disponibilità ad astenersi dai vaccini vivi attenuati durante lo studio e per 12 settimane dopo l’ultima dose di filgotinib nello studio.

Questa lista include solo i criteri di inclusione principali.

E.4

Principal exclusion criteria

- Any chronic medical condition (including but not limited to, cardiac or pulmonary disease, alcohol, or drug abuse) that, in the opinion of the investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol.
- Subject has a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
- Female subject who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and/or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.
- Male subject unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product.
- Subject is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
- Subject has a positive QuantiFERON® tuberculosis (TB) test at screening or subject has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
- History of malignancy except for subjects who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
- Subject meets discontinuation criteria of the SELECTION-LTE study.

This list only contains the key exclusion criteria.

- Qualsiasi condizione medica cronica (incluso ma non limitato a , malattie cardiache o polmonari, abuso di alcol o sostanze stupefacenti) che, a giudizio dello sperimentatore o dello sponsor, renderebbe il soggetto non idoneo allo studio o ne impedirebbe la conformità al protocollo dello studio.
- Il soggetto presenta un’ipersensibilità nota agli ingredienti di filgotinib o un’anamnesi di una reazione allergica significativa agli ingredienti di filgotinib, come determinato dallo sperimentatore.
- Soggetto di sesso femminile in gravidanza o allattamento, che intende iniziare una gravidanza o allattare al seno e/o che prevede di sottoporsi a donazione di ovuli o raccolta di ovuli ai fini della fertilizzazione attuale o futura, durante lo studio e fino alla fine dello studio.
- Soggetto di sesso maschile non disposto ad astenersi dalla donazione di sperma per almeno 90 giorni dopo l’ultima dose del prodotto sperimentale (IP).
- Il soggetto non è in grado o non è disposto a rispettare le restrizioni relative ai farmaci precedenti e concomitanti, come descritto nel protocollo.
- Il soggetto presenta un test QuantiFERON® per la tubercolosi (TB) positivo allo screening oppure il soggetto presenta 2 risultati indeterminati del test QuantiFERON® per la TB che richiedono l’interruzione del trattamento con l’IP.
- Anamnesi di tumore maligno, fatta eccezione per i soggetti che sono stati trattati con successo per carcinoma cutaneo non melanoma o carcinoma cervicale in situ.
- Il soggetto soddisfa i criteri di interruzione dello studio SELECTION-LTE

Questa lista include solo i criteri di esclusione principali.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects in corticosteroid-free clinical remission based on modified Mayo Clinical Score.

Percentuale di soggetti in remissione clinica senza corticosteroidi1 in base al punteggio della Mayo Clinic modificato.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 48

Settimana 48

E.5.2

Secondary end point(s)

- Time to patient-reported outcome based on 2 items (PRO2) flare.
- Time to endoscopic score-confirmed ulcerative colitis flare.
- Change from baseline in C-reactive protein and fecal calprotectin.
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) .
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious Adverse Events (AEs), and TEAEs leading to treatment discontinuation.

- Tempo alla riacutizzazione PRO2.
- Tempo alla riacutizzazione della colite ulcerosa (CU) confermata mediante punteggio endoscopico (ES).
- Variazione rispetto al basale della proteina C-reattiva (CRP) e della calprotectina fecale (FCP).
- Variazione rispetto al basale dell’IBDQ.
- Frequenza e gravità degli eventi avversi emergenti dal trattamento (TEAE), EA seri emergenti dal trattamento (SAE) e TEAE che portano all’interruzione del trattamento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Various time points throughout the study as per clinical study design.

Vari punti temporali durante lo studio secondo il disegno dello studio clinico.

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker assessments

Valutazione dei biomarcatori

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

India

Korea, Republic of

South Africa

Taiwan

United States

France

Poland

Spain

Switzerland

Czechia

Germany

Italy

Belgium

Hungary

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

When the last subject is switched to commercially available filgotinib (i.e. after completing minimum 48 weeks of treatment and the follow-up visit) or, in countries where filgotinib is not commercially available, when the last subject completes 216 weeks in the study.

Quando l'ultimo soggetto passa a filgotinib disponibile in commercio (cioè dopo aver completato un minimo di 48 settimane di trattamento e la visita di follow-up) o, nei paesi in cui filgotinib non è disponibile in commercio, quando l'ultimo soggetto completa 216 settimane nello studio.

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

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)

None

Nessuno

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

2022-10-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-18

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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