Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003153-15 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Lakefront Biotherapeutics NV | INDUSTRY |
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The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib 200 mg | Experimental | Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks |
|
| Filgotinib 100 mg | Experimental | Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks |
|
| Placebo | Experimental | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Tablet(s) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Combined Fistula Response at Week 24 | Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections > 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 | Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections > 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline. | Week 24 |
Not provided
Key Inclusion Criteria:
Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
Is willing and able to undergo MRI per protocol requirements
Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Crohn's and Colitis Center | Miami | Florida | 33136 | United States | ||
| Center for Interventional Endoscopy - Florida Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38366672 | Derived | Reinisch W, Colombel JF, D'Haens GR, Rimola J, Masior T, McKevitt M, Ren X, Serone A, Schwartz DA, Gecse KB. Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulising Crohn's Disease [DIVERGENCE 2]: A Phase 2, Randomised, Placebo-controlled Trial. J Crohns Colitis. 2024 Jun 3;18(6):864-874. doi: 10.1093/ecco-jcc/jjae003. |
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106 participants were screened. Participants who were non-responders, met disease worsening criteria or completed all procedures per protocol, were offered the option to continue into a separate Long Term Extension (LTE) study (GS-US-419-3896; NCT02914600), if deemed appropriate by the investigator.
Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 06 April 2017. The last study visit occurred on 17 February 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filgotinib 200 mg | Participants received filgotinib 200 milligrams (mg) and placebo to match (PTM) filgotinib 100 mg, once daily for 24 weeks. |
| FG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2020 | Feb 16, 2022 |
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| Placebo to match filgotinib | Drug | Tablet(s) administered orally once daily |
|
| Time to Clinical Fistula Response up to Week 24 | Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented. | Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24 |
| Time to Clinical Fistula Remission up to Week 24 | Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented. | Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24 |
| Percentage of Participants Who Achieved Proctitis Remission at Week 24 | The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score > 2. | Week 24 |
| Orlando |
| Florida |
| 32804 |
| United States |
| University of South Florida South Tampa Campus | Tampa | Florida | 33606 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Louisville Clinical Trials Unit | Louisville | Kentucky | 40202 | United States |
| John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic | Baltimore | Maryland | 21224 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center - IBD Clinic | Nashville | Tennessee | 37212-2702 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| DHAT Research Institute | Garland | Texas | 75044 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| McGuire DVAMC | Richmond | Virginia | 23249 | United States |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | 9020 | Austria |
| Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology | Vienna | 1090 | Austria |
| Universitaire Ziekenhuizen Leuven | Leuven | B-3000 | Belgium |
| Mount Sinai Hospital | Toronto | M5T 3L9 | Canada |
| Toronto Digestive Disease Associates Inc. | Toronto | M9V 4B8 | Canada |
| CHU Grenoble Alpes - Hopital Michallon (main office) | La Tronche | 38700 | France |
| CHU de Rennes - Hôpital Pontchaillou (main office) | Rennes | 85809 | France |
| CHU Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | 01307 | Germany |
| Universitatsklinkum Jena | Jena | 07747 | Germany |
| Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza | Békéscsaba | Bekes County | 5600 | Hungary |
| Bugát Pál Kórház, Gasztroenterológiai osztály | Gyöngyös | Heves County | 3200 | Hungary |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Royal Devon and Exeter Hospital, Department of Gastroenterology | Exeter | EX2 5DW | United Kingdom |
| FG002 | Placebo | Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgotinib 200 mg | Participants received filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks. |
| BG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for 24 weeks. |
| BG002 | Placebo | Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks. |
| BG003 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = local regulators did not allow collection of race information. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = local regulators did not allow collection of ethnicity information. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 Who Achieved Combined Fistula Response at Week 24 | Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections > 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline. | Participants in Full Analysis Set (all the randomized participants who received at least 1 dose of the study drug) with at least 1 draining external perianal fistula opening at baseline were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 | Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections > 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline. | Participants in the Full Analysis Set with at least 1 draining external perianal fistula opening at baseline were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Fistula Response up to Week 24 | Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented. | Participants in the Full Analysis Set with at least 1 draining external perianal fistula opening at baseline were analyzed. | Posted | Median | 90% Confidence Interval | days | Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Fistula Remission up to Week 24 | Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented. | Participants in the Full Analysis Set with at least 1 draining external perianal fistula opening at baseline were analyzed. | Posted | Median | 90% Confidence Interval | days | Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Proctitis Remission at Week 24 | The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score > 2. | Participants in the Full Analysis Set who had moderately to severely active proctitis at baseline were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 24 |
|
All-Cause Mortality: First dose date up to 24 weeks plus 30 days; Adverse Events: First dose date up to 24 weeks plus 30 days
All-Cause Mortality: All Randomized Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
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 PTM filgotinib 100 mg, once daily for up to Week 26. | 0 | 17 | 5 | 17 | 13 | 17 |
| EG001 | Filgotinib 100 mg | Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for up to Week 29.3. | 0 | 25 | 2 | 25 | 14 | 25 |
| EG002 | Placebo | Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for up to Week 27.9. | 0 | 15 | 1 | 15 | 11 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Crying | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Anal fungal infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2021 | Feb 16, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Other |
|
| Not Permitted |
|
| Hispanic or Latino |
|
| Not Permitted |
|
| Austria |
|
| Belgium |
|
| Hungary |
|
| United States |
|
| United Kingdom |
|
| Italy |
|
| France |
|
| Germany |
|
| Risk Difference in Percentages |
| 4.2 |
| 2-Sided |
| 90 |
| -26.5 |
| 34.3 |
The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method). |
| Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks. |
|
|
|
Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
|
|
|
| OG002 | Placebo | Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks. |
|
|
|