BridgeMD
The WILLOW LTE study with enpatoran in participants with SCLE, DLE and/or SLE
EU CTIS ID: 2024-510871-39-00
What this study is testing
Part 1 and Part 2: To evaluate the long-term safety and tolerability of enpatoran in participants with SCLE, DLE, and/or SLE
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Are ≥ 18 and ≤ 76 years of age at the time of signing the informed consent
- Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
- Have a Body Mass Index (BMI) within the greater than or equal to (>=) 40 kilograms per meter square (inclusive) at Screening
- Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
- Other protocol defined inclusion criteria could apply
You likely can't join if
- Participants who experienced serious event(s) related to the study intervention during the WILLOW study - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
- Ongoing or active clinically significant viral (including Severe acute arespiratory syndrome coronavirus 2 [(SARS‑CoV‑2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
- Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
- Participation in any other investigational drug study after the WILLOW study Week 24
- Other protocol defined exclusion criteria could apply
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Philippines
- Japan
- Korea, Republic of
- Australia
- Chile
- South Africa
- United States
- Argentina
- China
- Serbia
- Brazil
- Moldova, Republic of
- Mexico
- Colombia
- Taiwan
- Mauritius
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Philippines; Japan; Korea, Republic of; Australia; Chile and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.