The Willow LTE Study With M5049 in Patients With SCLE, DLE and/or SLE (WILLOW LTE)

RECRUITING

I'm interested ...!!

The purpose of the study is to assess the long term safety and efficacy of orally administered M5049 in patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 \[NCT05162586\]).

Conditions:

Systemic Lupus Erythematosus

Study Start (Actual) 2022-09-16

Primary Completion (Estimated) 2025-04-15

Study Completion (Estimated) 2025-04-15

Enrollment (Estimated) 532

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Torrance, California, United States

📍 Brandon, Florida, United States

📍 Miami, Florida, United States

📍 Indianapolis, Indiana, United States

📍 Grand Blanc, Michigan, United States

📍 Minneapolis, Minnesota, United States

📍 Columbus, Ohio, United States

📍 Memphis, Tennessee, United States

📍 Buenos Aires, Argentina

📍 Ciudad Autonoma Buenos Aires, Argentina

📍 Ciudad Autonoma de Buenos Aires, Argentina

📍 Mar del Plata, Argentina

📍 Mendoza, Argentina

📍 San Fernando, Argentina

📍 San Juan, Argentina

📍 San Miguel de Tucuman, Argentina

📍 San Miguel, Argentina

📍 Tucuman, Argentina

📍 Clayton, Australia

📍 Woolloongabba, Australia

📍 Belo Horizonte, Brazil

📍 Cuiabá, Brazil

📍 Graca, Brazil

📍 Juiz de Fora, Brazil

📍 Moinhos de Vento, Brazil

📍 Sao Jose, Brazil

📍 Sao Paulo, Brazil

📍 Haskovo, Bulgaria

📍 Plovdiv, Bulgaria

📍 Sevlievo, Bulgaria

📍 Sofia, Bulgaria

📍 Los Lagos, Chile

📍 Santiago, Chile

📍 Baotou, China

📍 Beijing, China

📍 Changchun, China

📍 Guangzhou, China

📍 Haikou, China

📍 Luoyang, China

📍 Nanchang, China

📍 Nanjing, China

📍 Shanghai, China

📍 Sichuan, China

📍 Suzhou, China

📍 Tianjin, China

📍 Xi'an, China

📍 Barranquilla, Colombia

📍 Bogotá, Colombia

📍 Bucaramanga, Colombia

📍 Medellin, Colombia

📍 Zipaquirá, Colombia

📍 Athens, Greece

📍 Thessaloniki, Greece

📍 Ramat Gan, Israel

📍 Asahikawa-shi, Japan

📍 Chiba-shi, Japan

📍 Chuo-ku, Japan

📍 Hiroshima-shi, Japan

📍 Kagoshima-shi, Japan

📍 Kawagoe-shi, Japan

📍 Kita-gun, Japan

📍 Sapporo-shi, Japan

📍 Sendai-shi, Japan

📍 Incheon, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Suwon, Korea, Republic of

📍 Quatre Bornes, Mauritius

📍 Ciudad de México, Mexico

📍 Cuernavaca, Mexico

📍 Guadalajara, Mexico

📍 Merida, Mexico

📍 Mexicali, Mexico

📍 Mexico, Mexico

📍 Monterrey, Mexico

📍 Torreon, Mexico

📍 Chisinau, Moldova, Republic of

📍 Davao City, Philippines

📍 Iloilo City, Philippines

📍 Lipa City, Philippines

📍 Makati City, Philippines

📍 Manila, Philippines

📍 Quezon City, Philippines

📍 Bialystok, Poland

📍 Koscian, Poland

📍 Krakow, Poland

📍 Kraków, Poland

📍 Poznan, Poland

📍 Szczecin, Poland

📍 Warszawa, Poland

📍 Bucharest, Romania

📍 Bucuresti, Romania

📍 Belgrade, Serbia

📍 Cape Town, South Africa

📍 Pretoria, South Africa

📍 Umhlanga, South Africa

📍 Castello, Spain

📍 Malaga, Spain

📍 Santander, Spain

📍 Valladolid, Spain

📍 Kaohsiung, Taiwan

📍 Taipei, Taiwan

More locations available...

Eligibility Criteria

Description

Inclusion Criteria:

* 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 \>= 40 kilograms per meter square (inclusive) at Screening
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* 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 respiratory 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

Ages Eligible for Study: 18 Years to 76 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-09-12
First Submitted that Met QC Criteria2022-09-12
First Posted2022-09-14

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-28
Last Update Posted2024-07-30
Last Verified2024-07