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Study of M5049 in CLE and SLE Participants

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ClinicalTrials.gov Identifier: NCT04647708
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Brief Summary:
This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Cutaneous Lupus Erythematosus Drug: M5049 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : July 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Part A (Cohort 1): M5049 Dose A Drug: M5049
Participants will receive low oral dose of M5049, twice daily in Part A.

Experimental: Part A (Cohort 2): M5049 Dose B Drug: M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.

Experimental: Part A (Cohort 3): M5049 Dose C Drug: M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.

Experimental: Part A (Cohort 4): M5049 Dose D Drug: M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.

Placebo Comparator: Part A: Placebo Drug: Placebo
Participants will receive placebo matched to M5049.

Experimental: Part B (Cohort 5): M5049 Dose E Drug: M5049
Participants will receive high oral dose of M5049, twice daily in Part B.

Placebo Comparator: Part B: Placebo Drug: Placebo
Participants will receive placebo matched to M5049.




Primary Outcome Measures :
  1. Part A: Cohort 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Event of Special Interest (AESI), TEAEs Leading to Permanent Treatment Discontinuation and Treatment-Related TEAEs [ Time Frame: Up to Day 102 ]
  2. Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Event of Special Interest (AESI), TEAEs Leading to Permanent Treatment Discontinuation and Treatment-Related TEAEs [ Time Frame: Up to Day 186 ]
  3. Part A: Cohort 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Based on Severity [ Time Frame: Up to Day 102 ]
  4. Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Based on Severity [ Time Frame: Up to Day 186 ]
  5. Part A: Cohort 1 and 2: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs, Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings [ Time Frame: Up to Day 102 ]
  6. Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs, Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings [ Time Frame: Up to Day 186 ]
  7. Part A: Cohort 1 and 2: Number of Participants with Confirmed Signs and Symptoms of Prodromal Seizure [ Time Frame: Up to Day 102 ]
  8. Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Confirmed Signs and Symptoms of Prodromal Seizure [ Time Frame: Up to Day 186 ]
  9. Part A: Cohort 1 and 2: Number of Participants with Suicidal Behavior and Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to Day 102 ]

Secondary Outcome Measures :
  1. Part A and Part B: Maximum Observed Plasma Concentration (Cmax) of M5049 [ Time Frame: Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  2. Part A and Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M5049 [ Time Frame: Day 1 and Day 29 ]
  3. Part A and Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049 [ Time Frame: Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  4. Part A and Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M5049 [ Time Frame: Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  5. Part A and Part B: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M5049 [ Time Frame: Day 1 and Day 29 ]
  6. Part A and Part B: Accumulation Ratio for Maximum Observed Plasma Concentration (Racc Cmax) of M5049 [ Time Frame: Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  7. Part A and Part B: Elimination Rate Constant (Lambda z) of M5049 [ Time Frame: Day 1 and Day 29 ]
  8. Part A and Part B: Apparent Terminal Half-life (t1/2) of M5049 [ Time Frame: Day 1 and Day 29 ]
  9. Part A and Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours Post-Dose (AUC0-12h) of M5049 [ Time Frame: Day 29 ]
  10. Part A and Part B: Dose Normalized Area Under Plasma Concentration-Time Curve from Time Zero to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049 [ Time Frame: Day 29 ]
  11. Part A and Part B: Total Body Clearance (CL/f) of M5049 [ Time Frame: Day 1 ]
  12. Part A and Part B: Apparent Volume of Distribution (Vz/f) of M5049 [ Time Frame: Day 1 ]
  13. Part A and Part B: Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of M5049 [ Time Frame: Day 1 ]
  14. Part A and Part B: Dose Normalized Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf/Dose) of M5049 [ Time Frame: Day 1 ]
  15. Part A and Part B: Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Activity Index (CLASI-A) [ Time Frame: Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  16. Part A and Part B: Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  17. Part A and Part B: Change from Baseline in 28-Joint Count [ Time Frame: Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]
  18. Part A and Part B: Change from Baseline in Physician Global Assessment (PGA) Score [ Time Frame: Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease area and activity index (CLASI-A) greater than or equal to [>= ] 6 and/or at least one active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
  • Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A >= 6
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Autoimmune or rheumatic disease other than SLE or CLE
  • Dermatological diseases other than cutaneous manifestations of SLE or CLE
  • Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
  • Ongoing or active clinically significant viral, bacterial or fungal infection
  • History of uncontrolled seizures or other neurological disorder
  • History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
  • History of malignancy
  • Other protocol defined exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647708


Contacts
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Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Bulgaria
Medical center Medconsult Pleven OOD Active, not recruiting
Pleven, Bulgaria
Medical Center-1-Sevlievo EOOD Recruiting
Sevlievo, Bulgaria
Military Medical Academy - MHAT - Sofia Active, not recruiting
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD Active, not recruiting
Sofia, Bulgaria
Germany
SocraTec R&D GmbH Recruiting
Erfurt, Germany
Fraunhofer ITMP (Fraunhofer Institute for Translational Medicine and Pharmacology) Recruiting
Frankfurt, Germany
Moldova, Republic of
ARENSIA Exploratory Medicine Phase I Unit, Clinical Republican Hospital Recruiting
Chisinau, Moldova, Republic of
North Macedonia
PHI University Clinic of Rheumatology Skopje Not yet recruiting
Skopje, North Macedonia
Spain
Hospital Universitario Nuestra Señora de Valme Recruiting
Sevilla, Spain
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Hospital Universitario Rio Hortega - Servicio de Medicina Interna Recruiting
Valladolid, Spain
Ukraine
Medical Center of Limited Liability Company "Harmoniya krasy", Department of clinical trials Active, not recruiting
Kyiv, Ukraine
Sponsors and Collaborators
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT04647708    
Other Study ID Numbers: MS200569_0004
2020-003118-11 ( EudraCT Number )
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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 the 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 https://bit.ly/IPD21

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Autoimmune Diseases
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases