Atopic dermatitis eczema
Conditions
Interventions
100mg LOU064 or matching placebo BID
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and female healthy subjects with an age range between 18 and 65 years (inclusive), and in good general health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. To participate in Part 6, subjects must additionally have chronic atopic dermatitis (AD) according to American Academy of Dermatology Consensus Criteria (Eichenfield et al 2014), that has been present for at least 1 year before the baseline visit and defined as: * Eczema Area and Severity Index (EASI) * 12 at screening and baseline * IGA (Investigator*s Global Assessment) * 3 on a 5-point scale at screening and baseline * BSA (Body Surface Area) involvement * 8% at screening and baseline * Subjects have applied a stable dose of bland topical emollient at least twice daily for at least 7 consecutive days immediately before the baseline visit Subjects must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 18-35 kg/m2 inclusive (part 6).
Exclusion criteria
Exclusion criteria: 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 7. Use of any systemic prescription drugs (including CYP3A inducers and inhibitors, and drugs with arrhythmogenic potential) 9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test 16. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. 18. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. 19. A positive Hepatitis B test result (Hepatitis B surface antigen/Hepatitis B core antibody) or Hepatitis C test result. 20. Subjects with a latent TB infection as indicated by the absence of any signs of active TB disease but with a positive IGRA. 36. Subjects previously enrolled and dosed in any part of this study are not eligible to re-enroll in the same or another part.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments: Adverse events Physical examination and anamnesis including a bruising log Test for occult blood in stool and urine Laboratory assessments including standard coagulation tests and platelets Vital signs ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: Cmax, Tmax, AUClast, AUCinf, T1/2, Vz/F and CL/F from the blood concentration-time data. PD: BTK occupancy in whole blood, ex-vivo anti-IgE activation of Basophils (Basotest) and skin prick test to a known allergen. Dermatology assessments to determine the potential effectiveness of LOU064 on skin symptoms in AD. | — |
Countries
Netherlands
Outcome results
None listed