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

February 19, 2024 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants 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]).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

532

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata - CIM
        • Principal Investigator:
          • Gladys Alicia Testa
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina
        • Recruiting
        • Cinme - Centro de Investigaciones Metabolicas
        • Contact:
        • Principal Investigator:
          • Ricardo L Galimberti
      • Mar del Plata, Argentina
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata - CIM
        • Principal Investigator:
          • Gladys Alicia Testa
        • Contact:
      • San Fernando, Argentina
        • Recruiting
        • Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
        • Principal Investigator:
          • Maria Alicia Lazaro
        • Contact:
      • San Juan, Argentina
        • Recruiting
        • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
        • Principal Investigator:
          • Jose Luis Cristian Moreno
        • Contact:
      • San Miguel, Argentina
        • Recruiting
        • Psoriahue-Medicina Interdisciplinar
        • Contact:
        • Principal Investigator:
          • Gabriel A Magarinos
      • San Miguel de Tucuman, Argentina
        • Recruiting
        • Investigaciones Clínicas Tucumán
        • Contact:
        • Principal Investigator:
          • Veronica Ines Bellomio
      • Tucuman, Argentina
        • Recruiting
        • Centro de Investigaciones Medicas Tucuman
        • Principal Investigator:
          • Walter J Spindler
        • Contact:
  • Australia
      • Clayton, Australia
        • Recruiting
        • Monash Medical Centre Clayton
        • Contact:
        • Principal Investigator:
          • Alberta Hoi
  • Bulgaria
      • Plovdiv, Bulgaria
        • Recruiting
        • MC Artmed OOD
        • Contact:
        • Principal Investigator:
          • Mariela Geneva-Popova
      • Sevlievo, Bulgaria
      • Sofia, Bulgaria
      • Sofia, Bulgaria
        • Recruiting
        • UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
        • Contact:
        • Principal Investigator:
          • Rumen Stoilov
      • Sofia, Bulgaria
        • Recruiting
        • Military Medical Academy - MHAT - Sofia
        • Principal Investigator:
          • Boycho Oparanov
        • Contact:
      • Sofia, Bulgaria
        • Recruiting
        • UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
        • Principal Investigator:
          • Rasho Rashkov
        • Contact:
  • Chile
      • Santiago, Chile
        • Recruiting
        • BioMedica Research Group - Psicomedica Clinical and Research Group
        • Contact:
        • Principal Investigator:
          • Elizabeth Jean Moreno Goio
      • Santiago, Chile
        • Recruiting
        • Centro Medico Prosalud
        • Contact:
        • Principal Investigator:
          • Irmgadt Annelise Goecke Sariego
      • Santiago, Chile
        • Recruiting
        • CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
        • Contact:
        • Principal Investigator:
          • Fernando Valenzuela
  • China
      • Baotou, China
        • Recruiting
        • The First Affiliated Hospital of BaoTou Medical College
        • Contact:
        • Principal Investigator:
          • Yongfu Wang
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital - Beijing Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Xiaofeng Zeng
      • Changchun, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Zhenyu Jiang
      • Luoyang, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xiaofei Shi
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Xinwang Duan
      • Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Yi Liu
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Wei Wei
  • Colombia
      • Barranquilla, Colombia
        • Recruiting
        • Centro de Investigacion Medico Asistencial S.A.S
        • Principal Investigator:
          • Juan Jose Jaller Raad
        • Contact:
      • Bogotá, Colombia
        • Recruiting
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
        • Principal Investigator:
          • Patricia Julieta Velez Sanchez
        • Contact:
      • Medellin, Colombia
        • Recruiting
        • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
        • Contact:
        • Principal Investigator:
          • Mauricio Ricardo Abello Banfi
      • Zipaquirá, Colombia
        • Recruiting
        • Healthy Medical Center
        • Contact:
        • Principal Investigator:
          • Danny Alexis Gomez Mora
  • Greece
      • Thessaloniki, Greece
        • Recruiting
        • General Hospital Papageorgiou
        • Contact:
        • Principal Investigator:
          • Elisavet Lazaridou
  • Japan
      • Chuo-ku, Japan
        • Recruiting
        • St. Luke's International Hospital - Dept of Immunology/Allergy
        • Contact:
        • Principal Investigator:
          • Takehiro Nakai
      • Kagoshima-shi, Japan
      • Kita-gun, Japan
        • Recruiting
        • Kagawa University Hospital - Dept of Immunology/ Rheumatology
        • Principal Investigator:
          • Hiroaki Dobashi
        • Contact:
      • Sendai-shi, Japan
        • Recruiting
        • Tohoku University Hospital - Dept of Hematology/Immunology
        • Principal Investigator:
          • Tomonori Ishii
        • Contact:
  • Korea, Republic of
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Chang-Hee Suh
  • Mauritius
  • Mexico
      • Ciudad de México, Mexico
        • Recruiting
        • CAIMED Investigacion en salud S.A de C.V.
        • Contact:
        • Principal Investigator:
          • Diana Laura Ferrusquía Toriz
      • Ciudad de México, Mexico
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
      • Cuernavaca, Mexico
        • Recruiting
        • Consultorio Privado Dr. Miguel Cortes Hernandez
        • Contact:
        • Principal Investigator:
          • Miguel Cortes Hernandez
      • Guadalajara, Mexico
        • Recruiting
        • Diseño y Planeacion en Investigacion Medica S.C.
        • Contact:
        • Principal Investigator:
          • Jorge Enrique Aguilar Arreola
      • Mexicali, Mexico
        • Recruiting
        • Centro Medico del Angel
        • Contact:
        • Principal Investigator:
          • Beatriz Elena Zazueta Montiel
      • Mexico, Mexico
        • Recruiting
        • Centro de Investigacion Clínica GRAMEL S.C
        • Contact:
        • Principal Investigator:
          • Luis Javier Jara Quezada
      • Mexico, Mexico
        • Recruiting
        • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
        • Contact:
        • Principal Investigator:
          • Gabriel Medrano Ramirez
      • Monterrey, Mexico
        • Recruiting
        • Centro Regiomontano de Estudios Clínicos Roma S.C.
        • Principal Investigator:
          • Iris J Colunga Pedraza
        • Contact:
      • Torreon, Mexico
        • Recruiting
        • CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
        • Contact:
        • Principal Investigator:
          • Sandra Araceli Sicsik Ayala
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Recruiting
        • ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
        • Contact:
        • Principal Investigator:
          • Svetlana Agachi
  • Philippines
      • Davao City, Philippines
        • Recruiting
        • Davao Doctors Hospital - Medicine
        • Contact:
        • Principal Investigator:
          • Llewellyn Hao
      • Iloilo City, Philippines
        • Recruiting
        • Iloilo Doctors Hospital
        • Contact:
        • Principal Investigator:
          • Caroline G Arroyo
      • Makati City, Philippines
        • Recruiting
        • Ospital ng Makati
        • Contact:
        • Principal Investigator:
          • Evan Glenn Vista
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
        • Principal Investigator:
          • Izabela Domyslawska
        • Contact:
      • Koscian, Poland
        • Recruiting
        • Prywatna Praktyka Lekarska prof Pawel Hrycaj
        • Contact:
        • Principal Investigator:
          • Pawel Hrycaj
      • Krakow, Poland
      • Kraków, Poland
      • Poznan, Poland
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Institute of Rheumatology
        • Contact:
        • Principal Investigator:
          • Mirjana Sefik Bukilica
      • Belgrade, Serbia
        • Recruiting
        • University Clinical Center of Serbia - Clinic of Alergology and Imunology
        • Contact:
        • Principal Investigator:
          • Snezana Arandjelovic
  • South Africa
      • Cape Town, South Africa
        • Recruiting
        • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
        • Principal Investigator:
          • Catherine E Spargo
        • Contact:
      • Umhlanga, South Africa
        • Recruiting
        • Naidoo, A - Netcare Umhlanga Hospital
        • Principal Investigator:
          • Asokan Naidoo
        • Contact:
  • Spain
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
        • Principal Investigator:
          • Ricardo Blanco Alonso
        • Contact:
      • Valladolid, Spain
        • Recruiting
        • Hospital Universitario Rio Hortega - Servicio de Medicina Interna
        • Contact:
        • Principal Investigator:
          • Maria Julia Barbado Ajo
  • United States
    • Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Recruiting
        • AA MRC LLC Ahmed Arif Medical Research Center
        • Contact:
        • Principal Investigator:
          • Ali A Karrar
    • Tennessee
      • Memphis, Tennessee, United States, 38119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M5049 low dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.
Drug: M5049 low dose
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 48 weeks.
Other Names:
  • Enpatoran
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Experimental: M5049 medium dose+ Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Drug: M5049 medium dose
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.
Other Names:
  • Enpatoran
Experimental: M5049 high dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Drug: M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.
Other Names:
  • Enpatoran
Experimental: M5049 very high dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Drug: M5049 very high dose
Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.
Other Names:
  • Enpatoran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Time Frame: Baseline up to Week 50
Baseline up to Week 50

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Time Frame: Baseline up to Week 50
Baseline up to Week 50
Percent Change from WILLOW Study Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Weeks 0, 2, 4, 12, 24, 36 and 48
Time Frame: Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Change from WILLOW Study Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Weeks 0, 2, 4, 12, 24, 36 and 48
Time Frame: Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Time Frame: At Weeks 24 and 48
At Weeks 24 and 48
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
Time Frame: At Weeks 24 and 48
At Weeks 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS200569_0048
  • 2022-000239-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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