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

Alfasigma

Status and phase: Active, not recruiting; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Filgotinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914535

GS-US-418-3899

2016-002765-58 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 1,173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,173 participants in 5 patient groups, including a placebo group

Filgotinib 200 mg (blinded dosing)

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Treatment:

Drug: Placebo

Drug: Filgotinib

Filgotinib 100 mg (blinded dosing)

Experimental group

Description:

Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks

Treatment:

Drug: Placebo

Drug: Filgotinib

Placebo (blinded dosing)

Placebo Comparator group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Treatment:

Drug: Placebo

Filgotinib 200 mg (open-label)

Experimental group

Description:

Filgotinib 200 mg for up to 336 weeks

Treatment:

Drug: Filgotinib

Filgotinib 100 mg (open-label)

Experimental group

Description:

Filgotinib 100 mg for up to 336 weeks

Treatment:

Drug: Filgotinib