NCT04647708CompletedPhase 1
Study of M5049 in CLE and SLE Participants
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
Source: ClinicalTrials.gov · Last updated 21 Feb 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 23 Nov 2020
- Start date
- 16 Dec 2020
- Primary completion date
- 19 Dec 2023
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Diseases
- Lupus (SLE)
- NCT number
- NCT04647708
- EudraCT number
- 2020-003118-11
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 16 Dec 2020 to the primary completion date, 19 Dec 2023
- 12 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Other protocol defined exclusion criteria could apply
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| Medical Center-1-Sevlievo EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Unknown status |
| Military Medical Academy - Mhat - Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| UMHAT "Sv. Ivan Rilski", EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| SocraTec R&D GmbH Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| Fraunhofer ITMP (Fraunhofer Institute for Translational Medicine and Pharmacology) Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Hospital Universitario Nuestra Señora de Valme Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Rio Hortega - Servicio de Medicina Interna Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| ARENSIA Exploratory Medicine Phase I Unit, Clinical Republican Hospital Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| PHI University Clinic of Rheumatology Skopje Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| Medical Center of Limited Liability Company "Harmoniya krasy", Department of clinical trials Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.