Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (DIVERSITY1)

Galapagos

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Other: Placebo; Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914561

2016-001367-36 (EudraCT Number)

GS-US-419-3895

Details and patient eligibility

About

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).

Enrollment: 1,372 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,372 participants in 11 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Other: Placebo

Cohort A: Filgotinib 100 mg (Induction Study)

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Other: Placebo

Cohort A: Placebo (Induction Study)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Filgotinib

Other: Placebo

Cohort B: Filgotinib 200 mg (Induction Study)

Experimental group

Description:

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

Treatment:

Drug: Filgotinib

Other: Placebo

Cohort B: Filgotinib 100 mg (Induction Study)

Experimental group

Description:

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

Treatment:

Drug: Filgotinib

Other: Placebo

Cohort B: Placebo (Induction Study)

Placebo Comparator group

Description:

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

Treatment:

Drug: Filgotinib

Other: Placebo

Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Filgotinib 200 mg to Placebo (Maintenance Study)

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Other: Placebo

Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Filgotinib 100 mg to Placebo (Maintenance Study)

Experimental group

Description:

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.

Treatment:

Drug: Filgotinib

Other: Placebo

Placebo to Placebo (Maintenance Study)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo