Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Filgotinib — DRUG
  Tablet administered orally once a day
• Placebo — DRUG
  Tablet administered orally once a day

Study Details

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Key Dates

First listed

Sep 26, 2016

Start date

Mar 17, 2017

Status verified

May 2024

Primary completion

Aug 1, 2023

Completion

Aug 1, 2023

Study Design

Enrollment

1,188 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Filgotinib 200 mg
  Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
• Experimental: Filgotinib 100 mg
  Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
• Placebo Comparator: Placebo
  Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From the First Dose to Week 312 ]

Locations (100)

Find similar trials in Dothan, AL

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