Ulcerative ColitisPhase 3CAPYBARANCT05479058
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
A Phase 3 study testing Filgotinib in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 50 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 50 sitesin 13 countries
- Study dates
- 26 Jul 2022to 9 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 13 countries.
50 sites in 13 countries
Poland12 sites
Przychodnia Vitamed NFZ
Bydgoszcz, 85-079
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009
Krakowskie Centrum Medyczne
Krakow, 31-501
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, 95-054
Santa Familia - Centrum Badań Profilaktyki i Leczenia
Lodz, 90-302
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, 35-302
Endoskopia Sopot
Sopot, 81-756
Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
Torun, 87-100
H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością
Tychy, 43-100
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warsaw, 03-580
Bodyclinic
Warsaw, 03-712
Centrum Medyczne Oporów
Wroclaw, 52-416
France8 sites
CHU Amiens-Picardie
Amiens, 80054
Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
Marseille, 13015
Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie
Nantes, 44000
Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition
Pessac, 33600
Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie
Pierre-Bénite, 69495
Hôpital Pontchaillou
Rennes, 35033
Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
Saint-Etienne, 42055
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie
Vandœuvre-lès-Nancy, 54500
United States5 sites
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Gastro Center of Maryland - Columbia
Columbia, Maryland, 21045
University of Miami
Miami, Florida, 33136
Gastroenterology Group of Naples
Naples, Florida, 34102
Rapid City Medical Center
Rapid City, South Dakota, 57701
Germany5 sites
DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend
Berlin, 14050
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
EUGASTRO GmbH
Leipzig, 04103
Klinikum Lüneburg
Lüneburg, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423
Italy4 sites
IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II
Castellana Grotte, 70013
Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva
Catanzaro, 88100
Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello
Pisa, 56124
Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
Rozzano, 20089
South Korea4 sites
Yeungnam University Medical Center
Daegu, 42415
Kyung Hee University Hospital
Seoul, 02447
Kangbuk Samsung Hospital
Seoul, 03181
Yonsei University Health System Severance Hospital Gastroenterology
Seoul, 03722
United Kingdom4 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Norfolk and Norwich University Hospital
Norwich, NR4 YUY
Saint Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Czechia2 sites
Hepato-Gastroenterology HK
Hradec Králové, 500 12
GEP Clinic
Prague, 130 00
Hungary2 sites
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, 1097
Bugát Pál Kórház
Gyöngyös, 3200
Taiwan1 site
National Taiwan University Hospital Center for Infection Control
Taipei, 10002
About this study
Official 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
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.
Read the detailed description
Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.
- Conditions
- Ulcerative Colitis
- Being tested
- Filgotinib, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called GS-6034, GLPG0634
Administered orally once daily
PlaceboDrug
Administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib 200 mg | Experimental | Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. Receives: Drug: Filgotinib; Drug: Placebo |
| Filgotinib 100 mg | Experimental | Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. Receives: Drug: Filgotinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
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.
Measured: Week 48
Secondary outcomes (6)
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
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.
Measured: Baseline up to Week 48
Time to ES-Confirmed UC Flare
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.
Measured: Baseline up to Week 48
Change From Baseline in C-Reactive Protein (CRP)
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.
Measured: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Fecal Calprotectin (FCP)
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.
Measured: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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.
Measured: Baseline, Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
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.
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start26 Jul 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Why it stopped: the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479058
- Sponsor's protocol ID
- GLPG0634-CL-341
- Other IDs
- 2022-000719-30
- Acronym
- CAPYBARA
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2022
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05479058
- Acronym / sponsor ID
- CAPYBARA / GLPG0634-CL-341
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgotinib 200 mg | Experimental | Drug: Filgotinib, Drug: PlaceboParticipants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. |
| Filgotinib 100 mg | Experimental | Drug: Filgotinib, Drug: PlaceboParticipants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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 exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: GS-6034, GLPG0634Administered orally once daily | Drug | Filgotinib 100 mg, Filgotinib 200 mg |
| PlaceboAdministered orally once daily | Drug | Filgotinib 100 mg, Filgotinib 200 mg |
Primary outcome
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
Time frame: Week 48
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.
6 secondary outcomes
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Time frame: Baseline up to Week 48
Time to ES-Confirmed UC Flare
Time frame: Baseline up to Week 48
Change From Baseline in C-Reactive Protein (CRP)
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Fecal Calprotectin (FCP)
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Baseline, Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
Time frame: Baseline up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galapagos Study Director study director
Lakefront Biotherapeutics NV
50 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Filgotinib in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 50 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Poland, France, United States, Germany, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.