Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (DIVERSITYLTE)
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ClinicalTrials.gov Identifier: NCT02914600 |
Recruitment Status :
Enrolling by invitation
First Posted : September 26, 2016
Last Update Posted : February 12, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Filgotinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Only 3 arms are blinded in this study. |
Primary Purpose: | Treatment |
Official Title: | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease |
Actual Study Start Date : | March 17, 2017 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Filgotinib Dose A (blinded dosing)
Filgotinib dose A + placebo to match filgotinib dose B for up to 144 weeks
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Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo Tablet(s) administered orally once daily |
Experimental: Filgotinib Dose B (blinded dosing)
Filgotinib dose B + placebo to match filgotinib dose A for up to 144 weeks
|
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo Tablet(s) administered orally once daily |
Placebo Comparator: Placebo (blinded dosing)
Placebo for up to 144 weeks
|
Drug: Placebo
Tablet(s) administered orally once daily |
Experimental: Filgotinib Dose A (open-label)
Filgotinib dose A for up to 144 weeks
|
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
|
Experimental: Filgotinib Dose B (open-label)
Filgotinib dose B for up to 144 weeks
|
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
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- Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [ Time Frame: Up to 144 weeks plus 30 days ]
- Change from Baseline in PRO2 Scores [ Time Frame: Baseline and up to 144 weeks ]PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.
- Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [ Time Frame: Baseline and up to 144 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 a Gilead-sponsored CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895
- 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
- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for CD
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914600

Study Director: | Gilead Study Director | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02914600 History of Changes |
Other Study ID Numbers: |
GS-US-419-3896 2016-002763-34 ( EudraCT Number ) |
First Posted: | September 26, 2016 Key Record Dates |
Last Update Posted: | February 12, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |