Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05479058
Registration number
NCT05479058
Ethics application status
Date submitted
26/07/2022
Date registered
29/07/2022
Date last updated
4/10/2024
Titles & IDs
Public title
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Query!
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
Query!
Secondary ID [1]
0
0
2022-000719-30
Query!
Secondary ID [2]
0
0
GLPG0634-CL-341
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CAPYBARA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo
Experimental: Filgotinib 200 mg - Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.
Experimental: Filgotinib 100 mg - Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.
Treatment: Drugs: Filgotinib
Administered orally once daily
Treatment: Drugs: Placebo
Administered orally once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
Query!
Assessment method [1]
0
0
The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity. The mMCS remission was defined as a total score of score =2, with endoscopic subscore of =1, stool frequency subscore of =1, and a rectal bleeding subscore of 0. Corticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [1]
0
0
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Query!
Assessment method [1]
0
0
PRO2 flare was defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore =2, and rectal bleeding subscore =1. PRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [1]
0
0
Baseline up to Week 48
Query!
Secondary outcome [2]
0
0
Time to ES-Confirmed UC Flare
Query!
Assessment method [2]
0
0
An ES-confirmed UC flare was defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. Each subscore graded from 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [2]
0
0
Baseline up to Week 48
Query!
Secondary outcome [3]
0
0
Change From Baseline in C-Reactive Protein (CRP)
Query!
Assessment method [3]
0
0
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.
Query!
Timepoint [3]
0
0
Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Query!
Secondary outcome [4]
0
0
Change From Baseline in Fecal Calprotectin (FCP)
Query!
Assessment method [4]
0
0
Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract.
Query!
Timepoint [4]
0
0
Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Query!
Secondary outcome [5]
0
0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Query!
Assessment method [5]
0
0
The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 \[severe problem\] to 7 \[normal health\]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.
Query!
Timepoint [5]
0
0
Baseline, Week 48
Query!
Secondary outcome [6]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
Query!
Assessment method [6]
0
0
An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment. A TEAE was defined as * An AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug. * And was either a newly reported event, or a worsening of an existing event. Serious TEAE was defined as a TEAE that * Resulted in death and was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly / birth defect; * Was medically significant.
Query!
Timepoint [6]
0
0
Baseline up to Week 48
Query!
Eligibility
Key inclusion criteria
Key
* Participants must have participated in the SELECTION-LTE study (GS-US-418-3899), who were on 200 mg filgotinib once daily and fulfilled 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;
* fecal calprotectin (FCP) =250 microgram per gram (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 had a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must have agreed to continued monthly urine dipstick pregnancy testing during filgotinib treatment.
* Female participants of childbearing potential must have agreed to use highly effective contraception measures as defined in the protocol.
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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 had a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
* Female participant who was pregnant or breastfeeding, or intended 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 was unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
* Participant had a positive QuantiFERON® tuberculosis (TB) test at screening or had 2 indeterminate QuantiFERON® TB test results that required Investigational product (IP) treatment interruption, or participant had 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 had been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
* Participant met discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/07/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
9/10/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
22
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Maryland
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
South Dakota
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Virginia
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Leuven
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Hradec Králové
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Praha
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Amiens
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Marseille
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Nantes
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Pessac
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Pierre-Bénite
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Rennes
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Saint-Étienne
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Vandœuvre-lès-Nancy
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Berlin
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Kiel
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Leipzig
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Lüneburg
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Minden
Query!
Country [21]
0
0
Hungary
Query!
State/province [21]
0
0
Budapest
Query!
Country [22]
0
0
Hungary
Query!
State/province [22]
0
0
Gyöngyös
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Castellana Grotte
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Catanzaro
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Pisa
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Rozzano
Query!
Country [27]
0
0
Korea, Republic of
Query!
State/province [27]
0
0
Daegu
Query!
Country [28]
0
0
Korea, Republic of
Query!
State/province [28]
0
0
Seoul
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Bydgoszcz
Query!
Country [30]
0
0
Poland
Query!
State/province [30]
0
0
Kraków
Query!
Country [31]
0
0
Poland
Query!
State/province [31]
0
0
Ksawerów
Query!
Country [32]
0
0
Poland
Query!
State/province [32]
0
0
Rzeszów
Query!
Country [33]
0
0
Poland
Query!
State/province [33]
0
0
Sopot
Query!
Country [34]
0
0
Poland
Query!
State/province [34]
0
0
Torun
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Tychy
Query!
Country [36]
0
0
Poland
Query!
State/province [36]
0
0
Warsaw
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Warszawa
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Wroclaw
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Lódz
Query!
Country [40]
0
0
South Africa
Query!
State/province [40]
0
0
Cape Town
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
Sevilla
Query!
Country [42]
0
0
Taiwan
Query!
State/province [42]
0
0
Taipei
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Cambridge
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Norwich
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
Prescot
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Galapagos NV
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05479058
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
0
0
Galapagos Study Director
Query!
Address
0
0
Galapagos NV
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/58/NCT05479058/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/58/NCT05479058/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05479058
Download to PDF