Phase 2 of Filgotinib in patients with active non-infectious uveitis
Research type
Research Study
Full title
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis.
IRAS ID
229691
Contact name
William Tucker
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2017-001485-17
Duration of Study in the UK
3 years, 8 months, 29 days
Research summary
Research Summary
This study is to evaluate the efficacy and safety of Filgotinib in patients with active non-infectious uveitis. Uveitis is inflammation of the inside of the eye, called the uvea. Most uveitis cases involve the front of the eye (anterior uveitis) and are managed with topical treatment. However, approximately 20% of cases involve the middle (intermediate uveitis), the rear (posterior uveitis) or the entire eye (pan-uveitis). These can be more difficult to treat and often require corticosteroids administered in or around the eye. Filgotinib is an oral, potent and selective JAK1- inhibitor that is currently in development for the treatment of multiple inflammatory conditions including uveitis.Approximately 110 participants will participate in the study worldwide with approximately 15 patients in the UK. The study has a screening period of up to 30 days, a treatment period of 52 weeks and a follow up visit 4 weeks post end of treatment. The total duration of the study will be approximately 60 weeks.
Enrolled patients will be randomly assigned in a 1:1 ratio to receive filgotinib or placebo. Treatment is double blinded so neither the patient nor their study doctor will know which arm the patient is on. Patients assigned to the filgotinib arm will receive an oral dose of 200mg once daily and patients assigned to the placebo arm will receive oral tablet once daily. Patients will receive either filgotinib or placebo for 52 weeks or until treatment failure. Patients will also receive a 60mg/day dose of prednisone at baseline followed by a tapered schedule so all patients will be off prednisone by week 15.
Study procedures include: medical history, vital signs, height and weight measurements, ECG, physical exam, blood samples, and questionnaires. Patients will be required to have a chest x-ray at screening or within 90 days prior to screening.
Summary of Results
What was the purpose of the study?
The main purpose of this study was to find out if filgotinib helps the signs and symptoms of noninfectious uveitis. Uveitis is inflammation of the uvea, the middle layer inside of the eye. There are 2 types of uveitis: infection and noninfectious uveitis. Infectious uveitis is caused by a virus, bacteria, other type of infection. Noninfectious uveitis is not caused by a virus or bacteria and sometimes the cause of the inflammation is not known. This study included people who had noninfectious uveitis.The main questions the researchers wanted to answer in this study were:
What was the percent of participants who had treatment failure by Week 24?
What side effects did participants have during the study, if any?
Treatment failure was defined by having at least 1 criterion out of 4 pre-specified in the study procedures.What happened during the study?
The study started in July 2017 and ended in April 2021. There were 74 participants who joined the study.
The study was randomized, which means that the researchers used a computer program to randomly choose the treatment each participant took. This helped make sure the treatments were chosen fairly. In this study, participants had an equal chance of receiving filgotinib or placebo.
All participants received 60 mg prednisone on Day 1 and then lower doses of prednisone all the way until Week 15 according to the study procedures. Following prednisone, the participants received the following treatment:
• 200 mg filgotinib tablet taken 1 time every day (referred to as Filgotinib group)
• placebo tablet taken 1 time every day (referred to as Placebo group)
A placebo looks like a treatment but does not have any drug in it. Researchers use a placebo as a point of comparison to identify whether a new treatment is effective and safe. None of the participants, doctors or other study staff knew what treatment each participant took. Participants took treatment for up to 1 year (52 weeks).What were the results of the study?
This is a summary of the main results from this study. In total, 74 participants started the study. There were 8 participants who left the study before Week 6, so the results in this section only include 66 participants.
Researchers wanted to know the percent of participants who had treatment failure by Week 24. The researchers found that 12 out of 32 participants (38%) in the filgotinib group had treatment failure and 23 out of 34 participants (68%) in the placebo group had treatment failure. However, this study was stopped due to an internal Gilead decision. This was not because of any safety reasons, but because Gilead decided not to continue testing filgotinib as a treatment for noninfectious uveitis. The study did not sign up as many participants as was originally planned. As a result, the researchers were not able to draw suitable conclusions from the study and the available results should be interpreted with caution.What did researchers find about the safety of filgotinib?
The medical events presented here may or may not have been related to the study treatment. No participants died during the study.
Medical events are considered serious if it results in death, is life-threatening, or considered by the study doctor to be medically important. They are also serious if they cause lasting events or require hospital care. Out of the 74 total participants, 2 participants left the study before taking any treatment, so the safety results in this section only include 72 participants. In the filgotinib group, 5 out of 37 participants (14%) had serious medical events and in the placebo group, 2 out of 5 participants (6%) had serious medical events during the study. None of these serious medical events happened in more than 1 participant in the study. Overall, the treatment with filgotinib was generally well tolerated.
This summary was created and approved by Gilead Sciences in March 2022. The information in this summary does not include any information available after this date.
Thank you
Clinical study participants belong to a large community of people who take part in clinical research around the world. They help researchers answer important health questions and find medical treatments for patients. Thank you to the participants who took part in this clinical study for filgotinib.REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/1174
Date of REC Opinion
15 Aug 2017
REC opinion
Further Information Favourable Opinion