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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000719-30 | EudraCT Number |
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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
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib 200 mg | Experimental | Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. |
|
| Filgotinib 100 mg | Experimental | Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 48 |
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Key Inclusion Criteria:
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:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Gastroenterology Group of Naples |
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The clinical trial was originally designed with the primary endpoint to be assessed at Week 48 after which participants would have received unblinded treatment. 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.
Participants who were in clinical remission with filgotinib 200 milligrams (mg) once daily for at least 2 consecutive quarterly visits in the ongoing long-term extension (LTE) SELECTION-LTE study (GS-US-418-3899; NCT02914535) and who met the eligibility criteria, were rolled over and randomized to this study. Participants were enrolled at study sites in Poland, France, Germany, the United States, Belgium, Republic of Korea, Spain, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filgotinib 200 mg | Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. |
| FG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2023 | Sep 9, 2024 |
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The study was double-blinded to treatment assignment until the last subject has reached the primary analysis time point.
| Placebo | Drug | Administered orally once daily |
|
| 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. | 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. | 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. | 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. | 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
Serious TEAE was defined as a TEAE that
| Baseline up to Week 48 |
| Naples |
| Florida |
| 34102 |
| United States |
| Gastro Center of Maryland - Columbia | Columbia | Maryland | 21045 | United States |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
| Universitair Ziekenhuis Leuven Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Hepato-Gastroenterology HK | Hradec Králové | 500 12 | Czechia |
| GEP Clinic | Prague | 130 00 | Czechia |
| CHU Amiens-Picardie | Amiens | 80054 | France |
| Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie | Marseille | 13015 | France |
| Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie | Nantes | 44000 | France |
| Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition | Pessac | 33600 | France |
| Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie | Pierre-Bénite | 69495 | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie | Saint-Etienne | 42055 | France |
| Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie | Vandœuvre-lès-Nancy | 54500 | France |
| DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend | Berlin | 14050 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| EUGASTRO GmbH | Leipzig | 04103 | Germany |
| Klinikum Lüneburg | Lüneburg | 21339 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet | Budapest | 1097 | Hungary |
| Bugát Pál Kórház | Gyöngyös | 3200 | Hungary |
| IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II | Castellana Grotte | 70013 | Italy |
| Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva | Catanzaro | 88100 | Italy |
| Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello | Pisa | 56124 | Italy |
| Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Przychodnia Vitamed NFZ | Bydgoszcz | 85-079 | Poland |
| Gabinet Endoskopii Przewodu Pokarmowego | Krakow | 31-009 | Poland |
| Krakowskie Centrum Medyczne | Krakow | 31-501 | Poland |
| Centrum Opieki Zdrowotnej Orkan-Med | Ksawerów | 95-054 | Poland |
| Santa Familia - Centrum Badań Profilaktyki i Leczenia | Lodz | 90-302 | Poland |
| Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| Endoskopia Sopot | Sopot | 81-756 | Poland |
| Torunskiego Centrum Gastrologii I Endoskopii - Gastromed | Torun | 87-100 | Poland |
| H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością | Tychy | 43-100 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz | Warsaw | 03-580 | Poland |
| Bodyclinic | Warsaw | 03-712 | Poland |
| Centrum Medyczne Oporów | Wroclaw | 52-416 | Poland |
| Mediclinic Panorama | Cape Town | 7500 | South Africa |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Yonsei University Health System Severance Hospital Gastroenterology | Seoul | 03722 | South Korea |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| National Taiwan University Hospital Center for Infection Control | Taipei | 10002 | Taiwan |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 YUY | United Kingdom |
| Saint Helens and Knowsley Teaching Hospitals NHS Trust | Prescot | L35 5DR | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all randomized participants who were administered study drug at least once.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgotinib 200 mg | Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. |
| BG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | As the study was terminated prior to any participant reaching the primary analysis time point at Week 48, the data for this endpoint was not collected and analyzed. | Posted | Week 48 |
|
| ||||||||||||||||||||||
| Secondary | 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. | Participants in the Full Analysis Set (FAS) (all randomized participants who were administered study drug at least once) were analyzed. | Posted | Median | 95% Confidence Interval | days | Baseline up to Week 48 |
|
| |||||||||||||||||||
| Secondary | 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. | Participants in the FAS were analyzed. | Posted | Median | 95% Confidence Interval | days | Baseline up to Week 48 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in C-Reactive Protein (CRP) | CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. | Participants in the FAS with available data were analyzed. As the study was terminated prior to any participant reaching the Week 48 time point, the data for Week 48 time point was not collected and analyzed. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48 |
|
| |||||||||||||||||||
| Secondary | 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. | Participants in the FAS with available data were analyzed. As the study was terminated prior to any participant reaching the Week 48 time point, the data for Week 48 time point was not collected and analyzed. | Posted | Mean | Standard Deviation | milligrams per kilogram (mg/kg) | Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48 |
|
| |||||||||||||||||||
| Secondary | 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. | As the study was terminated prior to any participant reaching the Week 48 time point, the data for this endpoint was not collected and analyzed. | Posted | Baseline, Week 48 |
| |||||||||||||||||||||||
| Secondary | 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
Serious TEAE was defined as a TEAE that
| Participants in the Safety analysis set were analyzed. | Posted | Count of Participants | Participants | Baseline up to Week 48 |
|
Baseline up to Week 48
The Safety Analysis Set included all randomized participants who were administered study drug at least once.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filgotinib 200 mg | Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally. | 0 | 11 | 0 | 11 | 6 | 11 |
| EG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally. | 0 | 11 | 0 | 11 | 6 | 11 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Postmenopause | Social circumstances | MedDRA 26.0 | Systematic Assessment | This is a sex-specific AE. Only female participants were at risk. |
|
This study was terminated as 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.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos N.V. | +32 15 342 900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2024 | Sep 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|