A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MOR106; Placebo
Intervention description: MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).; Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To investigate the safety and tolerability of repeated subcutaneous (s.c.) doses of MOR106
      administered concomitantly with topical corticosteroids (TCS) in participants with moderate
      to severe atopic dermatitis (AD) who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A BMI 18 - 40 kilogram per meter square (kg/m^2), inclusive.

          -  Diagnosis of atopic dermatitis for at least one year since first diagnosis as per the
             Hanifin and Rajka Criteria.

          -  Eczema Area and Severity Index (EASI) ≥ 16 at the screening and at the baseline visit
             (Day 1 predose).

          -  Investigators' Global Assessment (IGA) score ≥ 3 (on the 0 to 4 IGA scale, in which 3
             is moderate and 4 is severe) at the screening and baseline visits.

          -  Greater than or equal to 10% body surface area (BSA) of AD involvement at the
             screening and baseline visits.

          -  Willingness to use a non-medicated, simple bland emollient twice daily for at least 7
             days before the baseline visit and throughout the study.

        Exclusion Criteria:

          -  Prior treatment with MOR106.

          -  Known hypersensitivity to any investigational medicinal product (IMP) ingredients as
             determined by the investigator (such as, but not limited to, anaphylaxis requiring
             hospitalization).

          -  AD lesions located predominantly (≥ 50% of cumulative lesional area) on face and
             genital areas.

          -  Any concurrent illness, condition, disability, or clinically significant abnormality
             (including laboratory tests, a New York Heart Association Classification (NYHA) ≥
             III/IV) or clinically significant illness in the 3 months prior to initial IMP
             administration that, in the investigator's opinion, represents a safety risk for the
             participant's participation in the study, may affect the interpretation of clinical
             safety or efficacy data, or may prevent the participant from safely completing the
             assessments required by the protocol.

          -  Clinically significant abnormalities at the discretion of the investigator detected on
             vital signs or physical examination (other than AD) at screening or baseline (Day 1
             predose).

          -  History of or a current immunosuppressive condition (e.g. human immunodeficiency virus
             [HIV] infection, as determined by a positive HIV test at screening).

          -  Active chronic or acute skin infection requiring treatment with systemic (oral, sc or
             iv) antibiotics, antivirals or antifungals within 4 weeks of baseline, or clinical
             signs of infective eczema within 7 days before baseline (Day 1 pre-dose).

          -  Having used any of the following treatments:

               -  Prior exposure to Dupilumab.

               -  Immunosuppressive/immunomodulating drugs (e.g. systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, interferon (IFN)-γ, azathioprine,
                  methotrexate) within 4 weeks of baseline (Day 1) visit.

               -  Phototherapy (ultraviolet B [UVB] or Psoralen Ultraviolet A [PUVA]) for AD within
                  four weeks of baseline (Day 1) visit.

               -  Treatment with TCS or topical calcineurin inhibitor (TCI) within 7 days before
                  the baseline (Day 1) visit.

               -  Treatment with biologics within five half-lives (if known) or 12 weeks prior to
                  baseline visit, whichever is longer.

               -  Regular use (more than two visits per week) of a tanning booth/parlor within 4
                  weeks of the baseline visit.