Trials / Terminated
TerminatedNCT03568071
A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis
A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Galapagos NV · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed as a treatment for diseases such as psoriasis and atopic dermatitis. An antibody is a protein that is made by the body in a defense reaction against viruses and bacteria or other small particles. In this case, MOR106 will act against IL-17C interleukin by binding to it. This way it could be possible to act against these diseases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MOR 106 | The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C. |
| DRUG | Placebo | A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study. |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2020-03-03
- Completion
- 2020-03-03
- First posted
- 2018-06-26
- Last updated
- 2020-03-18
Locations
53 sites across 5 countries: Germany, Hungary, Poland, Slovakia, United Kingdom
Source: ClinicalTrials.gov record NCT03568071. Inclusion in this directory is not an endorsement.