Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)

• ClinicalTrials.gov Identifier: NCT03025308
• Recruitment Status: Active, not recruiting
• First Posted: January 19, 2017
• Last Update Posted: October 27, 2021
• Sponsor: Galapagos NV
• Collaborator: Gilead Sciences
• Information provided by (Responsible Party): Galapagos NV

Tracking Information

• First Submitted Date: January 17, 2017
• First Posted Date: January 19, 2017
• Last Update Posted Date: October 27, 2021
• Actual Study Start Date: February 28, 2017
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 16, 2019)

• Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 6 years ]
• Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 6 years ]

Original Primary Outcome Measures (submitted: January 17, 2017)

• Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 3 years ]
• Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 3 years ]

• Current Secondary Outcome Measures (submitted: May 16, 2019): Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 6 years ]
• Original Secondary Outcome Measures (submitted: January 17, 2017): Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 3 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
• Official Title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
• Brief Summary: The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.

Primary Purpose: Treatment

• Condition: Rheumatoid Arthritis

Intervention

• Drug: Filgotinib
  Tablet(s) administered orally once daily
  Other Names:

  • GS-6034
  • GLPG0634
• Drug: Placebo to match filgotinib
  Tablet(s) administered orally once daily

Study Arms

• Experimental: Blinded Phase: Filgotinib 200 mg
  Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
  Interventions:

  • Drug: Filgotinib
  • Drug: Placebo to match filgotinib
• Experimental: Blinded Phase: Filgotinib 100 mg
  Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
  Interventions:

  • Drug: Filgotinib
  • Drug: Placebo to match filgotinib
• Experimental: Open Label Phase: Filgotinib 200 mg
  Filgotinib 200 mg for up to 6 years
  Intervention: Drug: Filgotinib
• Experimental: Open Label Phase: Filgotinib 100 mg
  Filgotinib 100 mg for up to 6 years
  Intervention: Drug: Filgotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 16, 2019): 2731
• Original Estimated Enrollment (submitted: January 17, 2017): 2800
• Estimated Study Completion Date: May 2025
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:

  • Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug

    • OR
  • Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
• Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
• Males and females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception

Key Exclusion Criteria:

• Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
• Known hypersensitivity to the study drug or its excipients
• Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
• Removed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03025308
• Other Study ID Numbers: GS-US-417-0304; 2016-003630-25 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Galapagos NV
• Study Sponsor: Galapagos NV
• Collaborators: Gilead Sciences

Investigators

• Study Director: Galapagos Study Director; Gilead Sciences

• PRS Account: Galapagos NV
• Verification Date: October 2021