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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05540327




Registration number
NCT05540327
Ethics application status
Date submitted
12/09/2022
Date registered
14/09/2022

Titles & IDs
Public title
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Scientific title
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)
Secondary ID [1] 0 0
2022-000239-21
Secondary ID [2] 0 0
MS200569_0048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - M5049 low dose
Treatment: Drugs - M5049 medium dose
Treatment: Drugs - M5049 high dose
Treatment: Drugs - Placebo
Treatment: Drugs - M5049 very high dose

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.

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.

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 .

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.


Treatment: Drugs: 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.

Treatment: Drugs: M5049 medium dose
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.

Treatment: Drugs: M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.

Treatment: Drugs: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.

Treatment: Drugs: M5049 very high dose
Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Timepoint [1] 0 0
Baseline up to Week 50
Secondary outcome [1] 0 0
Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Timepoint [1] 0 0
Baseline up to Week 50
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Secondary outcome [4] 0 0
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Timepoint [4] 0 0
At Weeks 24 and 48
Secondary outcome [5] 0 0
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
Timepoint [5] 0 0
At Weeks 24 and 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
532
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [2] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Indiana
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Ohio
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United States of America
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Mar del Plata
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Argentina
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Mendoza
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Argentina
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San Fernando
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Argentina
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San Juan
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Argentina
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San Miguel de Tucuman
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Argentina
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San Miguel
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Argentina
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Tucuman
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Brazil
State/province [18] 0 0
Belo Horizonte
Country [19] 0 0
Brazil
State/province [19] 0 0
Cuiabá
Country [20] 0 0
Brazil
State/province [20] 0 0
Graca
Country [21] 0 0
Brazil
State/province [21] 0 0
Juiz de Fora
Country [22] 0 0
Brazil
State/province [22] 0 0
Moinhos de Vento
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Jose
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Haskovo
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sevlievo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Chile
State/province [29] 0 0
Los Lagos
Country [30] 0 0
Chile
State/province [30] 0 0
Santiago
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China
State/province [31] 0 0
Baotou
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Changchun
Country [34] 0 0
China
State/province [34] 0 0
Guangzhou
Country [35] 0 0
China
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Haikou
Country [36] 0 0
China
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Luoyang
Country [37] 0 0
China
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Nanchang
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China
State/province [38] 0 0
Nanjing
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Sichuan
Country [41] 0 0
China
State/province [41] 0 0
Suzhou
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China
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Tianjin
Country [43] 0 0
China
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Xi'an
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Bucaramanga
Country [47] 0 0
Colombia
State/province [47] 0 0
Medellin
Country [48] 0 0
Colombia
State/province [48] 0 0
Zipaquirá
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Greece
State/province [49] 0 0
Athens
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Greece
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Thessaloniki
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Israel
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Ramat Gan
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Japan
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Asahikawa-shi
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Japan
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Chiba-shi
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Japan
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Chuo-ku
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Japan
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Hiroshima-shi
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Japan
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Kagoshima-shi
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Japan
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Kawagoe-shi
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Japan
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Kita-gun
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Japan
State/province [59] 0 0
Sapporo-shi
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Japan
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Sendai-shi
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Korea, Republic of
State/province [61] 0 0
Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Mauritius
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Quatre Bornes
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Mexico
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Ciudad de México
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Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Mexicali
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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Torreon
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Moldova, Republic of
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Chisinau
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Philippines
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Davao City
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Philippines
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Iloilo City
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Philippines
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Lipa City
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Philippines
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Makati City
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Bialystok
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Poland
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Koscian
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Poland
State/province [82] 0 0
Krakow
Country [83] 0 0
Poland
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Kraków
Country [84] 0 0
Poland
State/province [84] 0 0
Poznan
Country [85] 0 0
Poland
State/province [85] 0 0
Szczecin
Country [86] 0 0
Poland
State/province [86] 0 0
Warszawa
Country [87] 0 0
Romania
State/province [87] 0 0
Bucharest
Country [88] 0 0
Romania
State/province [88] 0 0
Bucuresti
Country [89] 0 0
Serbia
State/province [89] 0 0
Belgrade
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Pretoria
Country [92] 0 0
South Africa
State/province [92] 0 0
Umhlanga
Country [93] 0 0
Spain
State/province [93] 0 0
Castello
Country [94] 0 0
Spain
State/province [94] 0 0
Malaga
Country [95] 0 0
Spain
State/province [95] 0 0
Santander
Country [96] 0 0
Spain
State/province [96] 0 0
Valladolid
Country [97] 0 0
Taiwan
State/province [97] 0 0
Kaohsiung
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Communication Center
Address 0 0
Country 0 0
Phone 0 0
+49 6151 72 5200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://bit.ly/IPD21


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05540327