Clinical trial NCT03864627: A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 169/Early discontinuation(ED)
Secondary outcomes:
measure: Serum Concentrations of MOR106
timeFrame: Day 1, Day 4, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 155 and Day 169
measure: Number of Participants With Anti-drug Antibodies (ADAs)
timeFrame: Day 1 up to Day 169/ED
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Huntington Beach
country: United States
facility: Marvel Research, LLC
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc.
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami LLC
state: Florida
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: New York
country: United States
facility: Greenwich Village Dermatology
state: New York
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
Study officials:
affiliation: Galapagos NV
name: Galapagos Medical Information
role: STUDY_DIRECTOR
References: