Atopic Dermatitis
Conditions
Brief 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.
Interventions
DRUGMOR 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.
DRUGPlacebo
A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF). * Able and willing to give voluntary written informed consent and meet all of the inclusion criteria and none of the
Exclusion criteria
before being enrolled in the study. The subjects must sign the informed consent form prior to any study-related procedures and agree to the schedule of assessments. * A body mass index (BMI) between ≥18 and ≤30 kg/m². * Diagnosis of chronic atopic dermatitis with at least 1 year since first diagnosis, as per the Hanifin and Rajka Criteria, fulfilling the following criteria: 1. EASI ≥12 at screening and ≥16 at baseline (Day 1 pre-dose). 2. Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and at baseline. 3. Greater than or equal to 10% body surface area (BSA) of atopic dermatitis involvement at screening. 4. Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before baseline and throughout the study. 5. Subject is a candidate for systemic therapy and has a history of inadequate response or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors before screening visit, as per investigator's opinion. * Willing to adhere to the following contraceptive restrictions: 1. Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline. 2. Female subjects of childbearing potential must use a highly effective method of contraception from 28 days prior to the first dose of study drug, during the study, and for at least 24 weeks after the last dose of study drug. 3. Non-vasectomized male subjects with a female partner of childbearing potential must agree to a highly effective form of contraception during the study, and for at least 24 weeks after last dose of study drug. 4. All male subjects must agree to use a condom from the first dose of Investigational Medicinal Product (IMP), during the study and for at least 24 weeks after the last dose of IMP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in Eczema Area and Severity Index (EASI) score. | From baseline to Day 85 | To assess the clinical efficacy of repeated IV doses of MOR106 as assessed by percentage change from baseline in EASI score at Day 85 visit. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. | At Day 85 | To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. | At Day 85 | To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Percent change in Scoring Atopic Dermatitis (SCORAD) score. | From baseline to Day 85 | To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome. |
| Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. | From baseline to Day 85 | To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome. |
| Characterization of the MOR106 immunogenetic profile. | From baseline through Day 197/ED visit | To assess the immunogenicity of repeated IV doses of MOR106. |
| MOR106 (AUC0-inf) | From baseline through Day 197/ED visit | To characterize the PK of repeated IV doses of MOR106. |
| The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs). | From screening up to Day 197/early discontinuation (ED) visit | To assess the safety and tolerability of repeated IV doses of MOR106. |
Countries
Germany, Hungary, Poland, Slovakia, United Kingdom
Outcome results
None listed