drugset / Trial / NCT03689829

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

NCT03689829 ↗

Phase 1 Terminated 44 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupOpen-labelBasic science

Summary

The 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.

Timeline

Start
2018-08-13
Primary completion
2020-03-02
Completion
2020-03-02

Outcome

Outcome not reported

Stopped: “MOR106 clinical development in atopic dermatitis was stopped for futility”

Drugs

EvaluationDrugModalityDoseRoute
Subject MOR106 Monoclonal antibody — Intravenous

Indications