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NCT07932795
Study of Multiple Ascending Doses (MAD) of M5542 in Participants With Moderate and Severe Eczema
Conditions: Eczema
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 56
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Location: Research Site Darmstadt
Summary
The main purpose of this study is to evaluate the safety and tolerability of multiple ascending dose (MAD) of M5542 in participants with Eczema.
Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of eczema with an onset of symptoms at least 6 months prior to Screening
* Topical treatments provide inadequate control for at least 4 consecutive weeks within 1 year of the first dose, or documented reason why they were medically inadvisable (for example \[e.g.\] important side effects or safety risks)
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Any uncontrolled medical conditions, other than eczema that in the opinion of the Investigator, put the participant at unacceptable risk, or will likely interfere with study assessments or data integrity. Other medical conditions should be stable at the time of Screening and be expected to remain stable for the duration of the study
* Other than eczema, the presence of a significant skin morbidity that will influence the Investigator's ability to assess the diagnosis of eczema and/or severity of disease (for example (e.g.) psoriasis, confirmed or suspected cutaneous T cell lymphoma, autoimmune bullous disease, fixed drug reaction, and Stevens Johnson Syndrome, other)
* History of malignancies, or current malignancies (except for fully resected non melanoma skin cancer, and in situ cervical carcinoma) within the past 5 years
* Known history of, or suspected, significant current or any past history of tuberculosis or non tuberculous mycobacterial infections (including a positive QuantiFERON® Tuberculosis Gold blood test within 4 weeks prior to or at the time of Screening)
* Other protocol defined exclusion criteria could apply
Source: ClinicalTrials.gov (NCT07932795). StuddyBuddy aggregates publicly available trial information.