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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
Date last updated
9/08/2024

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
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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
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Belo Horizonte
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Brazil
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Cuiabá
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Brazil
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Graca
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Brazil
State/province [21] 0 0
Juiz de Fora
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Brazil
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Moinhos de Vento
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Brazil
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Sao Jose
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Brazil
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Sao Paulo
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Bulgaria
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Haskovo
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Bulgaria
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Plovdiv
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Bulgaria
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Sevlievo
Country [28] 0 0
Bulgaria
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Sofia
Country [29] 0 0
Chile
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Los Lagos
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Chile
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Santiago
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China
State/province [31] 0 0
Baotou
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China
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Beijing
Country [33] 0 0
China
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Changchun
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China
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Guangzhou
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China
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Haikou
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China
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Luoyang
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China
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Nanchang
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China
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Nanjing
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China
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Shanghai
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China
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Sichuan
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China
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Suzhou
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China
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Tianjin
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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
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Colombia
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Medellin
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Colombia
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Zipaquirá
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Greece
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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
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Sapporo-shi
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Japan
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Sendai-shi
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Korea, Republic of
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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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Lipa City
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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
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Krakow
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Poland
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Kraków
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Poland
State/province [84] 0 0
Poznan
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Poland
State/province [85] 0 0
Szczecin
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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
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South Africa
State/province [92] 0 0
Umhlanga
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Spain
State/province [93] 0 0
Castello
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Spain
State/province [94] 0 0
Malaga
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Spain
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Santander
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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
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 \[NCT05162586\]).
Trial website
https://clinicaltrials.gov/study/NCT05540327
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05540327