- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07932795
Study of Multiple Ascending Doses (MAD) of M5542 in Participants With Moderate and Severe Eczema
A Phase 1b, Open Label Study Without Comparator to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses (MAD) of M5542 in Patients With Eczema
The main purpose of this study is to evaluate the safety and tolerability of multiple ascending dose (MAD) of M5542 in participants with Eczema.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Communication Center
- Telefonnummer: +49 6151 72 5200
- E-post: service@emdgroup.com
Studieorter
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Darmstadt, Tyskland
- Research Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: M5542
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Participants will receive loading dose of M5542 followed by maintenance doses as determined by the Safety Monitoring Committee (SMC). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Intervention Discontinuation
Tidsram: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
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From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
|
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments
Tidsram: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
|
Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs)
Tidsram: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
|
Number of Participants with Clinically Significant Changes from Baseline in Vital Signs
Tidsram: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
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From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Pharmacokinetic (PK) Serum Concentrations of M5542
Tidsram: Pre-dose on Days 1, 15, 43 and 113; 72 hours post-dose on Day 8; 24 hours post-dose on Day 120; 48 hours post-dose on Day 127; 72 hours post-dose on Days 141, 176 and 197
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Pre-dose on Days 1, 15, 43 and 113; 72 hours post-dose on Day 8; 24 hours post-dose on Day 120; 48 hours post-dose on Day 127; 72 hours post-dose on Days 141, 176 and 197
|
Samarbetspartners och utredare
Utredare
- Studierektor: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MS554201_0011
- 2026-526029-16-00 (Annan identifierare: EU CT number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
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