Atopic Dermatitis
Conditions
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female Japanese subject between 20-65 years of age, BMI 18-30 kg/m2, Diagnosis of atopic dermatitis for at least one year since first diagnosis, A candidate for systemic therapy, EASI equal or greater than 16, IGA equal or greater than 3, BSA equal or greater than 10
Exclusion criteria
Exclusion criteria: Prior treatment with MOR106. Having used any of the following treatments: i. Exposure to biological therapy for AD. ii. Immunosuppressive or immunomodulating drugs (e.g. systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-gamma, azathioprine, methotrexate, etc.) within 4 weeks of baseline (Day 1) visit. iii. Phototherapy (ultraviolet or Psoralen Ultraviolet A) for AD within 4 weeks of baseline (Day 1) visit. iv. Treatment with TCS or TCI within 7 days before the baseline (Day 1) visit. v. Treatment with biologics (for non-AD indications) within five half-lives (if known) or 12 weeks prior to baseline visit, whichever is longer. Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, New York Heart Association Classification (NYHA) equal or greater than III/IV) or clinically significant illness in the 3 months prior to initial IMP administration that, in the opinion by investigator, represents a safety risk for the participation of subject in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the subject from safely completing the assessments required by the protocol. Participation in another experimental therapy study within 90 days or five times the half life of the experimental therapy, whichever is longer, prior to dosing for this study or current enrolment in any other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety To investigate the safety and tolerability of multiple ascending subcutaneous (s.c.) doses of IP. | — |
Secondary
| Measure | Time frame |
|---|---|
| confirmatory pharmacokinetics pharmacodynamics - To evaluate the pharmacokinetics (PK) after multiple ascending s.c. doses of IP. - To monitor the occurrence of anti-drug antibodies (ADAs) as a measure of immunogenicity after multiple ascending s.c. doses of IP. | — |
Countries
Japan
Outcome results
None listed