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Active, Not Recruiting

NCT Number: NCT02914535

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

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 ulcerative colitis (UC).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
  • Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
  • Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
  • Females of childbearing potential must have a negative pregnancy test at Day 1
  • Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described
  • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

Key Exclusion Criteria:

  • Known hypersensitivity to the study drug
  • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
  • Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
  • Use of prohibited medications as outlined in the protocol

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

Treatment and study plan

Filgotinib

Drug

Tablet(s) administered orally once daily

Other names: GS-6034, GLPG0634

Placebo

Drug

Tablet(s) administered orally once daily

Primary outcomes

  1. Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests

    Time frame: Up to 336 weeks plus 30 days

Secondary outcomes

  1. Change From Baseline in Components of Mayo Clinic Score (MCS)

    Time frame: Baseline and up to 336 weeks

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study title

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

Acronym: SELECTIONLTE

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2016
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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