Providing Answers, Support and Hope in Northern Illinois, Indiana, Iowa, Michigan, and Minnesota
A research study for people with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE) currently enrolling
Study Title: The WILLOW Study with M5049 in SLE and CLE (SCLE and/or DLE)
Sponsor Name: EMD Serono Research & Development Institute, Inc.
Purpose of Study: The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) including subacute cutaneous lupus erythematosus (SCLE) and/or discoid lupus erythematosus (DLE) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting.
IMPORTANT NOTE: Please be informed that in the US we are currently ONLY looking for people with SLE.
What Does this Study Involve? This study will include up to 532 participants. The total study duration for each participant will be approximately 33 weeks.
This clinical trial is a Phase II, randomized, double-blind, placebo controlled clinical trial. At the study entry, patients will be assigned to one of 2 study groups:
- Group A (approximately 100 patients): patients with CLE (SCLE and/or DLE) or SLE with mostly active rash and mild disease activity, will receive the investigational medication at 25 mg, 50 mg, or 100 mg, or placebo, twice a day. You will have a 3 times higher chance to receive the investigational medication than placebo.
- Group B: patients with SLE with moderate to high disease activity, with or without active rash, will be assigned to Group B. Group B will be broken out into 2 parts:
- In Part 1, approximately 60 patients will receive either the investigational medication (100 mg twice a day) or a placebo (twice a day). Patients will have a double chance to receive the investigational medication compared with placebo.
- Part 2 will begin once all Part 1 patients have entered the study. In Part 2, patients will receive the investigational medication at 25 mg, 50 mg, or 100 mg, twice a day, or placebo. Patients will have a 3 in 4 chance to receive the investigational medication and a 1 in 4 chance to receive placebo.
Before you choose to participate, you should speak with your doctor.
You May Qualify for This Study If You:
- Are of the age 18 to 75
- Have active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
- Have active SLE with presence of CLASI-A >= 8 and BILAG 2004 1B, C, D, No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
- Receive a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
Other protocol defined inclusion criteria could apply.
If you have any of the following, you may not be able to participate in the study:
- Autoimmune or rheumatic disease other than SLE or CLE
- Dermatological diseases other than cutaneous manifestations of SLE or CLE
- Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
- Ongoing or active clinically significant viral, bacterial, or fungal infection
- History of uncontrolled seizures or other neurological disorderHistory of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
- History of malignancy
Other protocol defined exclusion criteria could apply.
Your study doctor will perform all mentioned above procedures and measures to determine whether you are eligible.
Study Type:
- Interventional
- Phase 2, randomized, double-blind, placebo controlled, multicenter
- International study; In the U.S., there are 15 participating sites in Indiana, Michigan, Tennessee, California, Florida, Ohio, Minnesota.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) patient and caregiver registry. Compensation is available.