A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients With Moderate to Severe Atopic Dermatitis



Status:Not yet recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:3/8/2019
Start Date:March 2019
End Date:January 2020
Contact:Evelyn Fox
Email:communications@glpg.com
Phone:+32 15 34 29 00

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A Randomized, Double-blind, Placebo-controlled, Multicentre Phase 2 Study to Evaluate the Safety and Tolerability of Subcutaneous MOR106 Administered Concomitantly With Topical Corticosteroids for Eight Weeks, in Adult Subjects With Moderate to Severe Atopic Dermatitis

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


Inclusion Criteria:

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

- A BMI 18 - 40 kg/m², 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
hospitalisation).

- 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)
greater than or equal to 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 subject's participation 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.

- 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 a biologic therapy for AD.

- 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 (for non-AD indications) 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.
We found this trial at
2
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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Saint John's, Newfoundland and Labrador
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