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CompletedNCT02914561DIVERSITY1Updated Dec 18, 2023Results posted

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

A Phase 3 interventional study of Filgotinib and Placebo in Crohn's Disease, sponsored by Lakefront Biotherapeutics NV. Completed at 513 sites in 41 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Lakefront Biotherapeutics NV · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,372
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's enrollment of 1,372 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Lakefront Biotherapeutics NV is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Browse Lakefront Biotherapeutics NV studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
  • Moderately to severely active CD
  • Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators
  • Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
  • Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

  • Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
  • Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any prohibited concomitant medications as described in the study protocol

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,372 participants (actual)

Study arms

  • Experimental
    Cohort A: Filgotinib 200 (mg) (Induction Study)

    Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Experimental
    Cohort A: Filgotinib 100 mg (Induction Study)

    Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Placebo comparator
    Cohort A: Placebo (Induction Study)

    Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Experimental
    Cohort B: Filgotinib 200 mg (Induction Study)

    Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Experimental
    Cohort B: Filgotinib 100 mg (Induction Study)

    Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Placebo comparator
    Cohort B: Placebo (Induction Study)

    Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

    Drug: Filgotinib · Other: Placebo

  • Experimental
    Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)

    Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

    Drug: Filgotinib

  • Experimental
    Filgotinib 200 mg to Placebo (Maintenance Study)

    Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

    Drug: Filgotinib · Other: Placebo

  • Experimental
    Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)

    Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

    Drug: Filgotinib

  • Experimental
    Filgotinib 100 mg to Placebo (Maintenance Study)

    Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

    Drug: Filgotinib · Other: Placebo

  • Placebo comparator
    Placebo to Placebo (Maintenance Study)

    Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

    Other: Placebo

Interventions

  • DrugFilgotinib

    Filgotinib tablets administered orally once daily.

    Also known as: GS-6034, GLPG0634

  • OtherPlacebo

    Placebo administered orally once daily.

06

What researchers measure

Primary outcomes

  1. Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.

    Time frame: Week 10

  2. Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10

    The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.

    Time frame: Week 10

  3. Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.

    Time frame: Week 58

  4. Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58

    The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.

    Time frame: Week 58

Secondary outcomes

  1. Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10

    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.

    Time frame: Week 10

  2. Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.

    Time frame: Week 10

  3. Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58

    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.

    Time frame: Week 58

  4. Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.

    Time frame: Week 58

  5. Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Sustained Clinical Remission by CDAI: CDAI \<150 combined at both Week 10 and Week 58.

    Time frame: Weeks 10 and 58

  6. Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.

    Time frame: Week 58

  7. Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58

    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.

    Time frame: Weeks 10 and 58

  8. Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58

    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. 6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.

    Time frame: Week 58

  9. Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4

    Plasma concentrations of filgotinib \[nanogram/milliliters (ng/mL)\].

    Time frame: Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose

  10. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10

    Plasma concentrations of filgotinib (ng/mL).

    Time frame: Week 10: Predose

  11. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26

    Plasma concentrations of filgotinib (ng/mL).

    Time frame: Week 26: At any timepoint

  12. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58

    Plasma concentrations of filgotinib (ng/mL).

    Time frame: Week 58: Pre-dose

  13. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4

    Plasma concentrations of GS-829845 (ng/mL).

    Time frame: Week 4: 0.5, 1, 2, and 3 hrs post dose

  14. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10

    Plasma concentrations of GS-829845 (ng/mL).

    Time frame: Week 10: Predose

  15. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26

    Plasma concentrations of GS-829845 (ng/mL).

    Time frame: Week 26: At any timepoint

  16. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58

    Plasma concentrations of GS-829845 (ng/mL).

    Time frame: Week 58: Pre-dose

07

Results

Posted Dec 18, 2023

Participant flow

Participants with diagnosis of moderately to severely Active Crohn's disease (CD) were enrolled in the study. Participants who were biologic-naïve or biologic-experienced were enrolled in Cohort A and participants who were biologic-experienced were enrolled in Cohort B, respectively.

Induction Study (Day 1 to Week 10)
Participant flow — Induction Study (Day 1 to Week 10)
MilestoneCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 200 mg to Placebo (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)Filgotinib 100 mg to Placebo (Maintenance Study)Placebo to Placebo (Maintenance Study)
Started22324523920423023100000
Treated22224523720222822900000
Completed20421321217718319200000
Not completed19322727473900000
Withdrew: Adverse event15141424311900000
Withdrew: Withdrawal by subject196071200000
Withdrew: Protocol violation04113100000
Withdrew: Physician decision15204400000
Withdrew: Non-compliance with study drug00100100000
Withdrew: Pregnancy10000000000
Withdrew: Lost to follow-up00100000000
Withdrew: Randomized but not treated10222200000
Maintenance Study (Weeks 11 to 58)
Participant flow — Maintenance Study (Weeks 11 to 58)
MilestoneCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 200 mg to Placebo (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)Filgotinib 100 mg to Placebo (Maintenance Study)Placebo to Placebo (Maintenance Study)
Started0000001185610556146
Treated0000001185610455145
Completed0000006421452674
Not completed0000005435603072
Withdrew: Protocol-specified disease worsening0000003132402543
Withdrew: Adverse event0000009211212
Withdrew: Withdrawal by subject00000051219
Withdrew: Protocol violation00000040204
Withdrew: Physician decision00000010213
Withdrew: Lost to follow-up00000030100
Withdrew: Non-compliance with study drug00000000100
Withdrew: Pregnancy00000010000
Withdrew: Randomized but not treated00000000111

Outcome measures

PrimaryInduction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.

Time frame:
Week 10
Reported as:
Number · percentage of participants
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
percentage of participantsCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 1032.9 (26.5 to 39.3)25.7 (20.0 to 31.4)19.8 (14.5 to 25.1)26.7 (20.4 to 33.1)16.7 (11.6 to 21.7)14.8 (10.0 to 19.7)
Statistical analysis
  • Cohort A: Filgotinib 200 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0017 · Stratified percentage difference: 12.7 · 95% CI 4.7 to 20.7
  • Cohort A: Filgotinib 100 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.1730 · Stratified percentage difference: 5.2 · 95% CI -2.4 to 12.7
  • Cohort B: Filgotinib 200 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0023 · Stratified percentage difference: 12.0 · 95% CI 4.1 to 19.9
  • Cohort B: Filgotinib 100 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.6038 · Stratified percentage difference: 1.8 · 95% CI -5.2 to 8.7
PrimaryInduction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10

The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.

Time frame:
Week 10
Reported as:
Number · percentage of participants
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
percentage of participantsCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 1023.9 (18.0 to 29.7)20.8 (15.5 to 26.1)18.1 (13.0 to 23.3)11.9 (7.2 to 16.6)13.6 (8.9 to 18.3)11.4 (7.0 to 15.7)
Statistical analysis
  • Cohort A: Filgotinib 200 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.1365 · Stratified percentage difference: 5.5 · 95% CI -2.0 to 12.9CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.
  • Cohort A: Filgotinib 100 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.5103 · Stratified percentage difference: 2.4 · 95% CI -4.8 to 9.5
  • Cohort B: Filgotinib 200 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.9797 · Stratified percentage difference: 0.1 · 95% CI -6.5 to 6.6CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.
  • Cohort B: Filgotinib 100 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.4264 · Stratified percentage difference: 2.4 · 95% CI -3.9 to 8.8
PrimaryMaintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 5842.9 (33.2 to 52.5)23.5 (14.6 to 32.4)28.3 (15.2 to 41.4)22.6 (10.4 to 34.9)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.0839 · Stratified percentage difference: 13.7 · 95% CI -1.0 to 28.4
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.8288 · Stratified percentage difference: 1.5 · 95% CI -12.1 to 15.0
PrimaryMaintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58

The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 5830.4 (21.4 to 39.3)18.4 (10.2 to 26.5)9.4 (0.6 to 18.2)13.2 (3.1 to 23.3)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.0038 · Stratified percentage difference: 20.6 · 95% CI 8.2 to 33.1
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.3466 · Stratified percentage difference: 5.8 · 95% CI -6.6 to 18.3
SecondaryInduction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10

The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.

Time frame:
Week 10
Reported as:
Number · percentage of participants
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
percentage of participantsCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 1032.9 (26.5 to 39.3)30.6 (24.6 to 36.6)25.7 (20.0 to 31.5)29.7 (23.2 to 36.3)18.9 (13.6 to 24.2)17.9 (12.7 to 23.1)
Statistical analysis
  • Cohort A: Filgotinib 200 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0963 · Stratified percentage difference: 6.9 · 95% CI -1.4 to 15.2
  • Cohort A: Filgotinib 100 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.3050 · Stratified percentage difference: 4.2 · 95% CI -3.9 to 12.2
  • Cohort B: Filgotinib 200 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0039 · Stratified percentage difference: 11.9 · 95% CI 3.7 to 20.2
  • Cohort B: Filgotinib 100 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.7556 · Stratified percentage difference: 1.1 · 95% CI -6.2 to 8.5
SecondaryInduction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.

Time frame:
Week 10
Reported as:
Number · percentage of participants
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
percentage of participantsCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 1052.3 (45.5 to 59.0)46.1 (39.7 to 52.6)39.7 (33.2 to 46.1)38.6 (31.7 to 45.6)35.5 (29.1 to 42.0)27.5 (21.5 to 33.5)
Statistical analysis
  • Cohort A: Filgotinib 200 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0074 · Stratified percentage difference: 12.0 · 95% CI 3.2 to 20.8
  • Cohort A: Filgotinib 100 mg (Induction Study) vs Cohort A: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.2159 · Stratified percentage difference: 5.5 · 95% CI -3.2 to 14.1
  • Cohort B: Filgotinib 200 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0110 · Stratified percentage difference: 11.6 · 95% CI 2.6 to 20.6
  • Cohort B: Filgotinib 100 mg (Induction Study) vs Cohort B: Placebo (Induction Study) · Cochran-Mantel-Haenszel · p = 0.0593 · Stratified percentage difference: 8.2 · 95% CI -0.4 to 16.7
SecondaryMaintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58

The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 5843.8 (34.1 to 53.4)29.6 (20.0 to 39.1)26.4 (13.6 to 39.2)24.5 (12.0 to 37.1)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.0382 · Stratified percentage difference: 16.8 · 95% CI 2.0 to 31.6
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.4263 · Stratified percentage difference: 5.8 · 95% CI -8.5 to 20.0
SecondaryMaintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 5845.5 (35.9 to 55.2)33.7 (23.8 to 43.5)34.0 (20.3 to 47.7)30.2 (16.9 to 43.5)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.1827 · Stratified percentage difference: 10.9 · 95% CI -4.7 to 26.4
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.5944 · Stratified percentage difference: 4.0 · 95% CI -11.1 to 19.2
SecondaryMaintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Sustained Clinical Remission by CDAI: CDAI \<150 combined at both Week 10 and Week 58.

Time frame:
Weeks 10 and 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 5838.4 (28.9 to 47.8)19.4 (11.1 to 27.7)22.6 (10.4 to 34.9)20.8 (8.9 to 32.6)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.0512 · Stratified percentage difference: 15.2 · 95% CI 1.0 to 29.3
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.9801 · Stratified percentage difference: -0.2 · 95% CI -13.3 to 13.0
SecondaryMaintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 5834.0 (19.9 to 48.1)4.9 (0.0 to 12.7)20.0 (2.3 to 37.7)12.0 (0.0 to 26.7)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.1900 · Stratified percentage difference: 14.0 · 95% CI -5.1 to 33.1
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.4248 · Stratified percentage difference: -5.5 · 95% CI -22.6 to 11.6
SecondaryMaintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58

The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.

Time frame:
Weeks 10 and 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 5841.1 (31.5 to 50.6)25.5 (16.4 to 34.7)20.8 (8.9 to 32.6)24.5 (12.0 to 37.1)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.0122 · Stratified percentage difference: 19.9 · 95% CI 5.7 to 34.0
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.7708 · Stratified percentage difference: 2.0 · 95% CI -12.0 to 16.1
SecondaryMaintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58

The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. 6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.

Time frame:
Week 58
Reported as:
Number · percentage of participants
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
percentage of participantsFilgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)Filgotinib 200 mg - Placebo (Maintenance Study)Filgotinib 100 mg - Placebo (Maintenance Study)
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 5832.0 (18.1 to 45.9)7.3 (0.0 to 16.5)20.0 (2.3 to 37.7)12.0 (0.0 to 26.7)
Statistical analysis
  • Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study) vs Filgotinib 200 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.2631 · Stratified percentage difference: 12.0 · 95% CI -8.3 to 32.3
  • Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study) vs Filgotinib 100 mg - Placebo (Maintenance Study) · Cochran-Mantel-Haenszel · p = 0.6444 · Stratified percentage difference: -3.4 · 95% CI -20.9 to 14.0
SecondaryInduction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4

Plasma concentrations of filgotinib \[nanogram/milliliters (ng/mL)\].

Time frame:
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Reported as:
Mean · ng/mL
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
ng/mLCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 41170 ± 1270611 ± 6341140 ± 1070604 ± 634
SecondaryInduction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10

Plasma concentrations of filgotinib (ng/mL).

Time frame:
Week 10: Predose
Reported as:
Mean · ng/mL
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
ng/mLCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 1046.8 ± 18021.3 ± 79.547.9 ± 21540.8 ± 139
SecondaryMaintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26

Plasma concentrations of filgotinib (ng/mL).

Time frame:
Week 26: At any timepoint
Reported as:
Mean · ng/mL
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
ng/mLFilgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26284 ± 62358.5 ± 150
SecondaryMaintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58

Plasma concentrations of filgotinib (ng/mL).

Time frame:
Week 58: Pre-dose
Reported as:
Mean · ng/mL
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
ng/mLFilgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 5875.8 ± 23816.9 ± 55.5
SecondaryInduction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4

Plasma concentrations of GS-829845 (ng/mL).

Time frame:
Week 4: 0.5, 1, 2, and 3 hrs post dose
Reported as:
Mean · ng/mL
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
ng/mLCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 43100 ± 15301800 ± 9363140 ± 14501870 ± 776
SecondaryInduction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10

Plasma concentrations of GS-829845 (ng/mL).

Time frame:
Week 10: Predose
Reported as:
Mean · ng/mL
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
ng/mLCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 102550 ± 13901290 ± 8012640 ± 14701480 ± 917
SecondaryMaintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26

Plasma concentrations of GS-829845 (ng/mL).

Time frame:
Week 26: At any timepoint
Reported as:
Mean · ng/mL
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
ng/mLFilgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 263090 ± 15001460 ± 814
SecondaryMaintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58

Plasma concentrations of GS-829845 (ng/mL).

Time frame:
Week 58: Pre-dose
Reported as:
Mean · ng/mL
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
ng/mLFilgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 582430 ± 14301220 ± 551

Adverse events

Collected over From first dose up to Week 62. Non-serious events are listed at a 2.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A: Filgotinib 200 mg (Induction Study)0/222 (0%)18/222 (8.1%)87/222 (39.2%)
Cohort A: Filgotinib 100 mg (Induction Study)0/245 (0%)16/245 (6.5%)90/245 (36.7%)
Cohort A: Placebo (Induction Study)0/237 (0%)15/237 (6.3%)90/237 (38%)
Cohort B: Filgotinib 200 mg (Induction Study)0/202 (0%)19/202 (9.4%)106/202 (52.5%)
Cohort B: Filgotinib 100 mg (Induction Study)0/228 (0%)36/228 (15.8%)107/228 (46.9%)
Cohort B: Placebo (Induction Study)0/229 (0%)26/229 (11.4%)109/229 (47.6%)
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)0/118 (0%)13/118 (11%)59/118 (50%)
Filgotinib 200 mg to Placebo (Maintenance Study)0/56 (0%)5/56 (8.9%)28/56 (50%)
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)0/104 (0%)14/104 (13.5%)59/104 (56.7%)
Filgotinib 100 mg to Placebo (Maintenance Study)0/55 (0%)3/55 (5.5%)25/55 (45.5%)
Placebo to Placebo (Maintenance Study)0/145 (0%)14/145 (9.7%)77/145 (53.1%)
Most frequent serious events
Showing 10 of 102
Most frequent serious events
EventCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 200 mg to Placebo (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)Filgotinib 100 mg to Placebo (Maintenance Study)Placebo to Placebo (Maintenance Study)
Crohn's diseaseGastrointestinal disorders7/2229/2457/2379/20210/22810/2293/1182/567/1041/554/145
SciaticaNervous system disorders0/2220/2450/2370/2020/2280/2290/1180/560/1041/550/145
PyelonephritisInfections and infestations1/2220/2450/2370/2020/2280/2290/1180/560/1041/550/145
Abdominal painGastrointestinal disorders0/2221/2451/2371/2020/2281/2290/1181/560/1040/551/145
Intestinal obstructionGastrointestinal disorders0/2222/2450/2370/2021/2281/2290/1181/561/1040/550/145
SubileusGastrointestinal disorders0/2220/2450/2370/2021/2280/2290/1181/560/1040/550/145
Anal abscessInfections and infestations0/2220/2450/2370/2023/2281/2292/1180/560/1040/551/145
Small intestinal obstructionGastrointestinal disorders1/2220/2450/2371/2020/2280/2290/1180/560/1040/552/145
AnaemiaBlood and lymphatic system disorders0/2220/2451/2370/2021/2281/2290/1180/561/1040/551/145
Renal colicRenal and urinary disorders1/2220/2450/2370/2021/2280/2290/1180/561/1040/551/145
Most frequent other events
Showing 10 of 42
Most frequent other events
EventCohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Filgotinib 200 mg to Placebo (Maintenance Study)Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)Filgotinib 100 mg to Placebo (Maintenance Study)Placebo to Placebo (Maintenance Study)
Crohn's diseaseGastrointestinal disorders5/22215/24516/2378/20214/22818/22915/11810/5622/10415/5526/145
Abdominal painGastrointestinal disorders16/2226/2458/23710/2028/22815/2298/1186/569/1043/559/145
NauseaGastrointestinal disorders11/22210/24511/23720/20210/22818/2296/1183/563/1042/554/145
ArthralgiaMusculoskeletal and connective tissue disorders5/22211/2456/2377/20214/2289/2293/1182/5610/1044/5510/145
HeadacheNervous system disorders13/22216/24512/23717/20214/22815/2294/1181/564/1042/5510/145
NasopharyngitisInfections and infestations7/2226/2458/2379/2029/22817/2296/1184/566/1042/559/145
PyrexiaGeneral disorders10/22210/2456/23711/2028/22810/2296/1184/563/1042/552/145
AnaemiaBlood and lymphatic system disorders3/2228/2457/2376/2028/2282/2293/1183/563/1041/554/145
Abdominal distensionGastrointestinal disorders3/2220/2453/2373/2023/2283/2291/1183/561/1040/551/145
Abdominal pain upperGastrointestinal disorders5/2222/2452/2374/2027/2285/2291/1183/564/1040/554/145

Baseline characteristics

The All Randomized Analysis Set included all participants who were randomized in the study.

Age, Categorical
Age, Categorical(Participants)Cohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Total
<=18 years0000000
Between 18 and 65 years2132332291912202271313
>=65 years1012101310459
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Total
Female110106130115129116706
Male11313910989101115666
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Total
Hispanic or Latino45428427
Not Hispanic or Latino2142372321932172201313
Unknown or Not Reported53395732
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Total
American Indian or Alaska Native0000101
Asian455244242531221
Native Hawaiian or Other Pacific Islander0000123
Black or African American36469634
White1661791851581821781048
Other23230111
Unknown or Not Reported75413121354
Region of Enrollment
Region of Enrollment(participants)Cohort A: Filgotinib 200 mg (Induction Study)Cohort A: Filgotinib 100 mg (Induction Study)Cohort A: Placebo (Induction Study)Cohort B: Filgotinib 200 mg (Induction Study)Cohort B: Filgotinib 100 mg (Induction Study)Cohort B: Placebo (Induction Study)Total
Hong Kong1030004
United States224145518460303
Czechia29912528
Malaysia4301008
Portugal1310229
Iceland0100001
Russia74533224
Greece0001102
Austria0001203
Netherlands63567936
South Korea02704518
Sweden0100012
Ireland1104017
Poland35253412712125
Slovakia03233415
France191516282131130
Serbia0110013
Croatia0110114
Romania2131209
Hungary66210116
Sri Lanka44300112
Japan810812101361
Ukraine18162000054
United Kingdom55467633
Switzerland10602413
India23302076591
Spain55158327
New Zealand21303211
Canada96774437
Belgium611715121162
Norway0111104
Taiwan41110310
Italy38376532
South Africa6111009
Georgia2110004
Israel29263729
Australia1168491149
Germany810919181983
Singapore0000224
08

Study locations

513 sites
  • Digestive Health Specialists of the Southeast
    Dothan, Alabama 36305, United States
  • Arizona Digestive Health - Sun City
    Sun City, Arizona 85351, United States
  • Southern California Research Center, Inc.
    Coronado, California 92118, United States
  • VVCRD Research
    Garden Grove, California 92845, United States
  • UC San Diego Health System
    La Jolla, California 92037, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Inland Empire Clinical Trials, LLC
    Rialto, California 92377, United States
  • Kaiser Permanente
    San Francisco, California 94118, United States
  • Clearview Medical Research, LLC
    Santa Clarita, California 91351, United States
  • University of Colorado Denver and Hospital
    Aurora, Colorado 80045, United States
  • South Denver Gastroenterology, PC
    Lone Tree, Colorado 80124, United States
  • Connecticut GI, PC-Research Division
    Farmington, Connecticut 06032, United States
  • Medstar Georgetown University Hospital (Patient Exams)
    Washington D.C., District of Columbia 20007, United States
  • Advanced Research, LLC
    Coral Springs, Florida 33067, United States
  • UF Clinical Research Center
    Gainesville, Florida 32610, United States
  • Florida Research Institute
    Lakewood Rch, Florida 34211, United States
  • Florida Center for Gastroenterology
    Largo, Florida 33777, United States
  • University of Miami Crohn's and Colitis Center
    Miami, Florida 33136, United States
  • Advanced Pharma CR
    Miami, Florida 33147, United States
  • Cordova Research Institute
    Miami, Florida 33155, United States
  • Vista Health Research, LLC
    Miami, Florida 33176, United States
  • Gastroenterology Group of Naples
    Naples, Florida 34102, United States
  • Center for Interventional Endoscopy - AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Gulf Region Clinical Research Institute
    Pensacola, Florida 32514, United States
  • Advanced Medical Research Center
    Port Orange, Florida 32127, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Shafran Gastroenterology Center
    Winter Park, Florida 32789, United States
  • Florida Medical Clinic, P.A.
    Zephyrhills, Florida 33540, United States
  • Gastroenterology Associates of Central Georgia, LLC
    Macon, Georgia 31201, United States
  • Gastrointestinal Specialists of Georgia
    Marietta, Georgia 30060, United States
  • Atlanta Gastroenterology Specialist, PC
    Suwanee, Georgia 30024, United States
  • Illinois Gastroenterology Group - Arlington Heights
    Arlington Heights, Illinois 60005, United States
  • Northwestern University, Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Illinois Gastroenterology Group - Gurnee
    Gurnee, Illinois 60031, United States
  • Indiana University Health University Hospital
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • University of Louisville, School of Medicine
    Louisville, Kentucky 40202, United States
  • Delta Research Partners, LLC
    Monroe, Louisiana 71201, United States
  • Louisiana Research Center, LLC
    Shreveport, Louisiana 71105, United States
  • Investigative Clinical Research
    Annapolis, Maryland 21401, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • MGG Group Co., Inc., Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Gastro Center of Maryland
    Columbia, Maryland 21045, United States
  • Meritus Center for Clinical Research
    Hagerstown, Maryland 21742, United States
  • Massachusetts General Hospital - Crohn's and Colitis Center
    Boston, Massachusetts 02114, United States
  • Clinical Research Institute of Michigan, LLC
    Chesterfield, Michigan 48047, United States
  • Spectrum Health Butterworth Hospital
    Grand Rapids, Michigan 49546, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Kansas City Research Institute
    Kansas City, Missouri 64131, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Las Vegas Medical Research
    Las Vegas, Nevada 89113, United States
  • AGA Clinical Research Associates, LLC
    Egg Harbor, New Jersey 08234, United States
  • NY Scientific
    Brooklyn, New York 11235, United States
  • NYU Langone Long Island Clinical Research Associates
    Great Neck, New York 11021, United States
  • New York University School of Medicine/NYU Gastroenterology Associates
    New York, New York 10016, United States
  • Lenox Hill Hospital
    New York, New York 10028, United States
  • Premier Medical Group of the Hudson Valley
    Poughkeepsie, New York 12601, United States
  • Charlotte Gastroenterology & Hepatology, PLLC
    Charlotte, North Carolina 28207, United States
  • Carolina's GI Research, LLC
    Raleigh, North Carolina 27607, United States
  • Fargo Gastroenterology and Hepatology Clinic
    Fargo, North Dakota 58103, United States
  • Consultants for Clinical Research
    Cincinnati, Ohio 45219, United States
  • UC Health Physicians Clifton
    Cincinnati, Ohio 45219, United States
  • Great Lakes Gastroenterology Research, LLC,
    Mentor, Ohio 44060, United States
  • Paramount Medical Research & Consulting, LLC
    Middleburg Heights, Ohio 44130, United States
  • Options Health Research LLC
    Tulsa, Oklahoma 74104, United States
  • Great Lakes Medical Research, LLC
    Harrisburg, Pennsylvania 17110, United States
  • Gastroenterology Associates of Orangeburg
    Orangeburg, South Carolina 29118, United States
  • WR-ClinSearch, LLC
    Chattanooga, Tennessee 37421, United States
  • Gastro One
    Germantown, Tennessee 38138, United States
  • Quality Medical Research
    Nashville, Tennessee 37211, United States
  • Vanderbilt University Medical Center - IBD Clinic
    Nashville, Tennessee 37212, United States
  • Texas Clinical Research Institute
    Arlington, Texas 76012, United States
  • Pinnacle Clinical Research
    Austin, Texas 78757, United States
  • Inquest Clinical Research
    Baytown, Texas 77521, United States
  • San Antonio Military Medical Center
    Fort Sam Houston, Texas 78219, United States
  • DHAT Research Institute
    Garland, Texas 75044, United States
  • Kelsey-Seybold Clinic
    Houston, Texas 77025, United States
  • Baylor College of Medicine- Baylor Medical Center
    Houston, Texas 77030, United States
  • The Methodist Hospital
    Houston, Texas 77030, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Centex Studies, Inc.
    Houston, Texas 77058, United States
  • Gulf Coast Research Group
    Houston, Texas 77098, United States
  • Clinical Associates in Research Therapeutics of America, LLC
    San Antonio, Texas 78212, United States
  • Gastroenterology Research of San Antonio
    San Antonio, Texas 78229, United States
  • Pinnacle Clinical Research
    San Antonio, Texas 78229, United States
  • TDDC San Marcos
    San Marcos, Texas 78666, United States
  • Texas Digestive Disease Consultants (IP Shipment)
    Southlake, Texas 76092, United States
  • Spring Gastroenterology
    The Woodlands, Texas 77380, United States
  • Tyler Research Institute, LLC
    Tyler, Texas 75701, United States
  • HP Clinical Research
    Bountiful, Utah 84010, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
  • Charlottesville Medical Research Center, LLC
    Charlottesville, Virginia 22911, United States
  • Gastroenterology Associates of Tidewater
    Chesapeake, Virginia 23320, United States
  • Emeritas Research Group LLC
    Leesburg, Virginia 20176, United States
  • McGuire DVAMC, GI (111N)
    Richmond, Virginia 23249, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • University of Wisconsin Hospital & Clinics
    Madison, Wisconsin 53792, United States

Showing the first 100 of 513 sites across 41 countries.

09

References and documents

Publications

  • Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2. PubMed 39637881 ↗

Study documents

  • Study protocol · Dec 2, 2021
  • Statistical analysis plan · Jan 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Nov 2022, 72 months.

Results were first posted in Dec 2023, 1 year 1 month after primary completion.

Of 66 industry-sponsored phase 3 interventional studies under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 68. This study's 72 months is above that.

Counting every sponsor, half of 82 studies reached it within 49 months; a quarter within 36 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2016
First posted
Sep 26, 2016
StartActual
Oct 31, 2016
Primary completionActual
Nov 11, 2022
CompletionActual
Nov 11, 2022
Results first posted
Dec 18, 2023
Last update
Dec 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02914561
Lead sponsor
Lakefront Biotherapeutics NV
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Sep 26, 2016
Start date
Oct 31, 2016
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Results posted
Dec 18, 2023
Last update
Dec 18, 2023

Study contacts

Galapagos Study Director
study director · Lakefront Biotherapeutics NV

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: GLPG0634

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