Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
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
    Filgotinib tablets administered orally once daily.
    Other names:
    • GS-6034
    • GLPG0634
  • Other: Placebo
    Placebo administered orally once daily.
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
    Placebo administered orally once daily.

More Details

Status
Completed
Sponsor
Galapagos NV

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.