A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

• Male or female between 18-65 years of age (extremes included), on the day of signinginformed consent form (ICF).

• Able and willing to give voluntary written informed consent and meet all of theinclusion criteria and none of the exclusion criteria before being enrolled in thestudy. The subjects must sign the informed consent form prior to any study-relatedprocedures 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, asper 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, inwhich 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 dermatitisinvolvement at screening.

4. Willingness to continue stable use of an additive free, basic, bland emollienttwice 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 inadequateresponse or has a contraindication to topical corticosteroids and/or topicalcalcineurin 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 pregnancytest at screening, and a negative urine pregnancy test at baseline.

2. Female subjects of childbearing potential must use a highly effective method ofcontraception from 28 days prior to the first dose of study drug, during thestudy, and for at least 24 weeks after the last dose of study drug.

3. Non-vasectomized male subjects with a female partner of childbearing potentialmust agree to a highly effective form of contraception during the study, and forat least 24 weeks after last dose of study drug.

4. All male subjects must agree to use a condom from the first dose ofInvestigational Medicinal Product (IMP), during the study and for at least 24weeks after the last dose of IMP.

Exclusion Criteria:

• Known hypersensitivity to study drug ingredients or history of any significantallergic reaction to any drug as determined by the investigator, such as anaphylaxisrequiring hospitalization.

• Prior treatment with MOR106.

• Positive serology for hepatitis B (positive hepatitis B surface [HBs] antigen and/orpositive hepatitis core antibody [HBc]), or hepatitis C virus (HCV) antibody or anyhistory of hepatitis from any cause with the exception of hepatitis A. Subjects whoare immune to hepatitis B because of vaccination can be included.

• History of or current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection), including history of invasive opportunistic infections (e.g., TB,histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis),despite infection resolution or unusually frequent, recurrent, or prolongedinfections, per investigator judgment.

• Subjects with a history of Varicella zoster virus who experienced any episode orrecurrence of Herpes Zoster infection within 1 year of screening or ≥ one episode orHerpes Zoster within 1 year of screening must be excluded. (A history of Herpessimplex types 1 and 2 and vaginal candidiasis are permitted.)

• Pregnant or breast feeding female or subject is intending to become pregnant orbreastfeed.

• Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, ≥ New York Heart Association Classification (NYHA)III/IV) or clinically significant illness in the 3 months prior to initial study drugadministration that, in the investigator's opinion, represents a safety risk for thesubject's participation in the study, may affect the interpretation of clinical safetyor efficacy data, or may prevent the subject from safely completing the assessmentsrequired by the protocol.

• Any of the following laboratory findings:

1. White blood cell count <3.0 x 109 cells/L

2. Neutrophil count <1.5 x 109 cells/L

3. Platelet count <100 x 109 cells/L

4. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 xupper limit of normal (ULN)

• History of malignancy within the past 5 years prior to screening with the exception ofnon-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, carcinomain situ of the cervix or of the breast, prostate cancer T1a or T1b using the TNM (tumour, nodes, metastasis) clinical staging system.

• Clinically significant abnormalities at the discretion of the investigator detected onvital signs or physical examination (other than atopic dermatitis) at screening orbaseline (Day 1 pre-dose).

• History of eczema herpeticum in the last 12 months prior to screening.

• Subjects who have had an attenuated vaccination within 4 weeks of baseline or areexpected to have one during the course of the study.

• Participation in another experimental therapy study within 5 times the half-life (ifknown) or 12 weeks (if not known) of the experimental therapy, prior to baseline, orcurrent enrollment in any other interventional study.

• Having used any of the following treatments:

1. Exposure to a biologic therapy for atopic dermatitis

2. Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids,cyclosporine, mycophenolate-mofetil, interferon-gamma, azathioprine,methotrexate) within 4 weeks of baseline

3. Phototherapy (ultraviolet [UV] B or psoralen and ultraviolet A [PUVA]) for atopicdermatitis within 4 weeks of baseline

4. Treatment with topical corticosteroids or topical calcineurin inhibitors within 2weeks of baseline

5. Treatment with biologics (for non atopic dermatitis indications within 5half-lives (if known) or 12 weeks prior to baseline (if unknown)

6. Regular use (more than 2 visits per week) of a tanning booth/parlour within 4weeks of screening

• Active chronic or acute infection requiring treatment with systemic (oral, SC or IV)antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals, within 4weeks of baseline, or clinical signs of infective eczema within 1 week beforebaseline. Note: subjects may be rescreened after infection resolves.

• Investigator, research assistant, pharmacist, study coordinator, or other staff orrelative thereof, who is directly involved in the conduct of the study.

• Not able to manage the electronic diary (e-diary) as per assessment of theinvestigator.