Clinical trial • Phase II • Immunology|Dermatology
ENPATORAN for Subacute cutaneous lupus erythematosus | Discoid lupus erythematosus | Systemic lupus erythematosus
Phase II trial of ENPATORAN for Subacute cutaneous lupus erythematosus | Discoid lupus erythematosus | Systemic lupus erythematosus.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Subacute cutaneous lupus erythematosus | Discoid lupus erythematosus | Systemic lupus erythematosus
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-05-2024
- First CTIS Authorization Date
- 17-07-2024
Trial design
Randomised, enpatoran (active) and enpatoran placebo (placebo comparator); dose and schedule not specified in provided documents-controlled Phase II trial across 13 sites in Poland, Bulgaria, Romania and others.
- Randomised
- Yes
- Comparator
- Enpatoran (active) and Enpatoran Placebo (placebo comparator); dose and schedule not specified in provided documents
- Target Sample Size
- 202
Eligibility
Recruits 202 No vulnerable populations selected (isVulnerablePopulationSelected: false); participants are adults (≥18). Informed consent is required and subject information / ICF documents are provided..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); participants are adults (≥18). Informed consent is required and subject information / ICF documents are provided.
Inclusion criteria
- {"criterion_text":"- Are ≥ 18 and ≤ 76 years of age at the time of signing the informed consent"}
- {"criterion_text":"- Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study"}
- {"criterion_text":"- Have a Body Mass Index (BMI) within the greater than or equal to (>=) 40 kilograms per meter square (inclusive) at Screening"}
- {"criterion_text":"- Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1"}
- {"criterion_text":"- Other protocol defined inclusion criteria could apply"}
Exclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- Ongoing or active clinically significant viral (including Severe acute arespiratory syndrome coronavirus 2 [(SARS‑CoV‑2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization"}
- {"criterion_text":"- Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24"}
- {"criterion_text":"- Participation in any other investigational drug study after the WILLOW study Week 24"}
- {"criterion_text":"- Other protocol defined exclusion criteria could apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)","definition_or_measurement_approach":"Measured by incidence counts of TEAEs, SAEs and AESIs in Part 1"}
- {"endpoint_text":"- Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)","definition_or_measurement_approach":"Measured by incidence counts of TEAEs, SAEs and AESIs in Part 2"}
Secondary endpoints
- {"endpoint_text":"- Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected","definition_or_measurement_approach":"Number/proportion of participants with laboratory parameter abnormalities and with abnormal corrected QT interval (QTc) as assessed by scheduled laboratory and ECG assessments"}
Recruitment
- Planned Sample Size
- 202
- Recruitment Window Months
- 67
- Consent Approach
- Informed consent required from participants (participants are adults ≥18). Subject information and informed consent forms (ICFs) available in multiple language versions (examples in documents list: EN, BG, EL, PL, ES, RO) and both Part 1 and Part 2 ICF versions are provided; consent provided by participant (no paediatric assent procedures required).
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 65
Poland
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 711
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- Not applicable
- Principal Investigator Name
- Magdalena Celinska-Lowenhoff
- Principal Investigator Email
- magdalena.lowenhoff@gmail.com
- Contact Person Name
- Magdalena Celinska-Lowenhoff
- Contact Person Email
- magdalena.lowenhoff@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 714
- Number Of Sites
- 3
- Number Of Participants
- 26
Sites
- Site Name
- Dkc Fokus-5 Lzip OOD
- Department Name
- Not applicable
- Principal Investigator Name
- Grisha Mateev
- Principal Investigator Email
- grisha_mateev@yahoo.com
- Contact Person Name
- Grisha Mateev
- Contact Person Email
- grisha_mateev@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of rheumatology
- Principal Investigator Name
- Rasho Rashkov
- Principal Investigator Email
- proff_rashkov@yahoo.com
- Contact Person Name
- Rasho Rashkov
- Contact Person Email
- proff_rashkov@yahoo.com
- Site Name
- Diagnostics And Consultancy Center Sveti Georgi EOOD
- Department Name
- Not applicable
- Principal Investigator Name
- Irida Vasileva
- Principal Investigator Email
- iridavasileva@gmail.com
- Contact Person Name
- Irida Vasileva
- Contact Person Email
- iridavasileva@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 714
- Number Of Sites
- 5
- Number Of Participants
- 4
Sites
- Site Name
- Saint Maria Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Andra-Rodica Balanescu
- Principal Investigator Email
- balanescu.andra@gmail.com
- Contact Person Name
- Andra-Rodica Balanescu
- Contact Person Email
- balanescu.andra@gmail.com
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Mihai Abobului
- Principal Investigator Email
- mihai.abobului.ext@arensia-em.com
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.abobului.ext@arensia-em.com
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Bogdan Horia Chicos
- Principal Investigator Email
- b_chicos@yahoo.com
- Contact Person Name
- Bogdan Horia Chicos
- Contact Person Email
- b_chicos@yahoo.com
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Rheumatology
- Principal Investigator Name
- Razvan Adrian Ionescu
- Principal Investigator Email
- mihai.abobului.ext@arensia-em.com
- Contact Person Name
- Razvan Adrian Ionescu
- Contact Person Email
- mihai.abobului.ext@arensia-em.com
- Site Name
- Saint Maria Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Florian Berghea
- Principal Investigator Email
- berghea1@gmail.com
- Contact Person Name
- Florian Berghea
- Contact Person Email
- berghea1@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 653
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Pre-educational Pathology Clinic & Rheumatology Unit
- Principal Investigator Name
- Petros Sfikakis
- Principal Investigator Email
- psfikakis@med.uoa.gr
- Contact Person Name
- Petros Sfikakis
- Contact Person Email
- psfikakis@med.uoa.gr
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- B’ Dermatology Clinic
- Principal Investigator Name
- Elisavet Lazaridou
- Principal Investigator Email
- bethlaz@auth.gr
- Contact Person Name
- Elisavet Lazaridou
- Contact Person Email
- bethlaz@auth.gr
Spain
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 10-05-2026
- Processing Time Days
- 713
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- Principal Investigator Name
- Antonio Fernandez Nebro
- Principal Investigator Email
- afernandezn@gmail.com
- Contact Person Name
- Antonio Fernandez Nebro
- Contact Person Email
- afernandezn@gmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Rheumatology
- Principal Investigator Name
- Francisco Javier Blanco García
- Principal Investigator Email
- fblagar@sergas.es
- Contact Person Name
- Francisco Javier Blanco García
- Contact Person Email
- fblagar@sergas.es
Sponsor
Primary sponsor
- Full Name
- Merck Healthcare KGaA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1,10,11,12,15 (value: 'Site contracts. Centralized ECG Services. Provide the software functionality for data collection per protocol requirements. Also supply device'),2,3,6,8
- Name
- IQVIA RDS Hellas Single Member S.A.
- Responsibilities
- sponsorDuties codes: 1,12,5,8
- Name
- Iqvia Laboratories Limited
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,15 (value: 'Site contracts. Centralized ECG Services. Provide the software functionality for data collection per protocol requirements. Also supply device'),2,3,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,5,8","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH (Switzerland address)","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"sponsorDuties code: 15 (value: 'Medical Equipment Supplies and Management')","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsorDuties code: 15 (value: 'PK Analysis')","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Enpatoran
- Active Substance
- ENPATORAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1; MIA number: DE_HE_01_MIA_2023-0007
- Investigational Product Name
- Enpatoran Placebo
- Modality
- Other
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