A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Published: 07/12/2017

General Information:

Study Objective

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 Gilead-sponsored Filgotinib treatment study in Crohn's disease (CD).

Phase of study

open label extension

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Eligibility:

Age

Adult (18+)

Gender

Female

Male

Disease Type

crohns-disease

Severity

Moderate

Severe

Eligibility 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 met all eligibility criteria from a Gilead-sponsored CD parent protocol
Females of childbearing potential must have a negative pregnancy test at Day 1
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol, 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, would make the individual unsuitable for the study or would prevent compliance with the study protocol
Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol
Use of prohibited medications as outlined in the study protocol

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

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Study Details:

Description of Treatment or Intervention (Mechanism of Action)

This is a long-term extension study. Patients who have completed or did not respond well to study treatment in the prior Gilead study may participate in the study. The dose received in this study will vary and depends on what happened in the prior Gilead study.
Mechanism of Action: Filgotinib is an oral investigational drug called a “JAK1 inhibitor” that is taken as a pill once a day. JAK1 inhibitors may slow damage to the digestive system by slowing down the activity of immune cells.

Possible Risks & Side Effects

The study involves taking an investigational (experimental) drug. Since the drug is investigational, there may be risks that are not yet identified. The investigational drug affects the immune system, and may weaken the body’s ability to fight off infection. A possible risk of being in the study is an increased risk of infection. Infections have been reported in previous studies of this drug.
Some side effects have been seen in people who have taken this study drug before. Across different studies of this study drug in different types of patients, some of the more common side effects include headache, sleepiness and fatigue, nausea, upper abdominal discomfort, and abnormal taste in mouth.
At this time, the effect of the study drug on pregnancy is not known. Strict use of birth control must be followed for both men and women.
With any drug there is a risk of allergic reaction, which can range from mild (such as itching) to serious (such as problems breathing).
The study requires blood draws, stool samples, and ECGs. Collecting a blood sample from a vein may cause pain, bruising, lightheadedness, fainting, and very rarely, infection or injury to the nerves at the site of the needle stick. After you have an ECG, you may have mild irritation, slight redness, and itching on your skin where the recording patches are attached.
You may be asked personal questions during the study to understand the effect the disease has on your life.

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Contact Information:

Site Locations

Advanced Medical Research Center 1690 Dunlawton AVE Suite 110 Port Orange, Florida 32127

Gilead Sciences