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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05479058




Registration number
NCT05479058
Ethics application status
Date submitted
26/07/2022
Date registered
29/07/2022
Date last updated
7/11/2023

Titles & IDs
Public title
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Scientific title
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
Secondary ID [1] 0 0
2022-000719-30
Secondary ID [2] 0 0
GLPG0634-CL-341
Universal Trial Number (UTN)
Trial acronym
CAPYBARA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo

Experimental: Filgotinib 200 mg - Participants will receive filgotinib 200 mg and placebo to match filgotinib 100 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with endoscopic score (ES)-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study.
Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 200 mg q.d.
The maximum duration of the treatment will be 216 weeks.

Experimental: Filgotinib 100 mg - Participants will receive filgotinib 100 mg and placebo to match filgotinib 200 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study.
Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 100 mg q.d.
The maximum duration of the treatment will be 216 weeks.


Treatment: Drugs: Filgotinib
Tablets administered orally once daily

Treatment: Drugs: Placebo
Tablets administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Timepoint [1] 0 0
Baseline (Day 1) up to 216 weeks
Secondary outcome [2] 0 0
Time to ES-Confirmed UC Flare
Timepoint [2] 0 0
Baseline (Day 1) up to 216 weeks
Secondary outcome [3] 0 0
Change From Baseline in C-Reactive Protein (CRP) up to Week 48
Timepoint [3] 0 0
Baseline, up to Week 48
Secondary outcome [4] 0 0
Change From Baseline in Fecal Calprotectin (FCP) up to Week 48
Timepoint [4] 0 0
Baseline, up to Week 48
Secondary outcome [5] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48
Timepoint [5] 0 0
Baseline, Week 48
Secondary outcome [6] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation
Timepoint [6] 0 0
Baseline up to 216 weeks

Eligibility
Key inclusion criteria
Key

- Participants must be participating in the SELECTION-LTE study (GS-US-418-3899),
currently on 200 mg filgotinib q.d. and fulfill the following conditions:

- partial Mayo Clinical Score remission over a period of at least 2 consecutive
quarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to 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 within 6 months prior to screening or FCP =250
µg/g during the screening of the present study.

- sigmoidoscopy ES of 0 or 1 (local score) at screening.

- Willing to refrain from live attenuated vaccines during the study and for 12 weeks
after the last dose of filgotinib in the study.

- Female participants 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.

- Female participants of childbearing potential must agree to use highly effective
contraception measures as defined in the protocol.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 participant unsuitable for the study or would prevent compliance with
the study protocol.

- Participant has a known hypersensitivity to filgotinib ingredients or history of a
significant allergic reaction to filgotinib ingredients as determined by the
investigator.

- Female participant 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.

- Participant is unable or unwilling to comply with restrictions regarding prior and
concomitant medication as described in the protocol.

- Participant has a positive QuantiFERON® tuberculosis (TB) test at screening or has 2
indeterminate QuantiFERON® TB test results that require IP treatment interruption, or
participant has sign and symptoms of TB reactivation at screening.

- History of malignancy during or in the last 5 years prior to participation in the UC
parent studies, except for participants who have been successfully treated for
nonmelanoma skin cancer or cervical carcinoma in situ.

- Participant meets discontinuation criteria of the SELECTION-LTE study
(GS-US-418-3899).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/10/2023
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
South Dakota
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Czechia
State/province [6] 0 0
Hradec Králové
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha
Country [8] 0 0
France
State/province [8] 0 0
Amiens
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
France
State/province [11] 0 0
Pessac
Country [12] 0 0
France
State/province [12] 0 0
Pierre-Bénite
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Saint-Étienne
Country [15] 0 0
France
State/province [15] 0 0
Vandœuvre-lès-Nancy
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Kiel
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Germany
State/province [19] 0 0
Lüneburg
Country [20] 0 0
Germany
State/province [20] 0 0
Minden
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Gyöngyös
Country [23] 0 0
Italy
State/province [23] 0 0
Castellana Grotte
Country [24] 0 0
Italy
State/province [24] 0 0
Catanzaro
Country [25] 0 0
Italy
State/province [25] 0 0
Pisa
Country [26] 0 0
Italy
State/province [26] 0 0
Rozzano
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Daegu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Poland
State/province [29] 0 0
Bydgoszcz
Country [30] 0 0
Poland
State/province [30] 0 0
Kraków
Country [31] 0 0
Poland
State/province [31] 0 0
Ksawerów
Country [32] 0 0
Poland
State/province [32] 0 0
Rzeszów
Country [33] 0 0
Poland
State/province [33] 0 0
Sopot
Country [34] 0 0
Poland
State/province [34] 0 0
Torun
Country [35] 0 0
Poland
State/province [35] 0 0
Tychy
Country [36] 0 0
Poland
State/province [36] 0 0
Warsaw
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Poland
State/province [38] 0 0
Wroclaw
Country [39] 0 0
Poland
State/province [39] 0 0
Lódz
Country [40] 0 0
South Africa
State/province [40] 0 0
Cape Town
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Cambridge
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Norwich
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Prescot
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galapagos NV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at
least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899,
NCT02914535), are planned to be rolled over and randomized in this study. The primary
objective of this study is to evaluate the efficacy of filgotinib in participants in stable
clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d.
compared to participants remaining on 200 mg q.d.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05479058
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05479058