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MOR106

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos · Dermatitis atopica.

Más ensayos de: Dermatitis atópica.

Fase

Fase 1

Estado

Interrumpido

Participantes

44

previstos

Centros

15

Fin del objetivo primario

mar 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «MOR106 clinical development in atopic dermatitis was stopped for futility».

Qué mide

The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 1. (From study drug administration until Day 50 postdose or early discontinuation (ED) visit) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe clinical study consists of three parts: * Part 1 with healthy volunteers. * Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease). For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous). For Part 2 and Part 3 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03689829), actualizada en mar 2020.