A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT03864627
- Lead Sponsor
- Galapagos NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
- 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.
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Prior treatment with MOR106.
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Known hypersensitivity to any investigational medicinal product (IMP) ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).
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AD lesions located predominantly (≥ 50% of cumulative lesional area) on face and genital areas.
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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.
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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).
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History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, as determined by a positive HIV test at screening).
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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).
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. MOR106 320 mg MOR106 Participants will receive MOR106 320 milligrams (mg) via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency topical TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection will be administered on Day 1.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) Day 1 up to Day 169/Early discontinuation(ED) An Adverse Events (AE) was any untoward medical occurrence, new or worsening of any pre-existing condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs: AES with an onset date on or after the start date of the IMP administration. AESIs: skin-related events (SRE) (except exacerbation and infective exacerbation of AD) or injection site reactions (ISRs) as per common terminology criteria for AEs (Grade 3: ulceration or necrosis; severe tissue damage; operative intervention indicated, Grade 4: life-threatening consequences; urgent intervention indicated, Grade 5: death ). An SAE: AE that resulted in any of the following outcomes: death; life threatening; results in persistent or significant disability/incapacity; requires in-patient hospitalization or prolongation of existing hospitalization; congenital anomaly/birth defect; is medically significant.
- Secondary Outcome Measures
Name Time Method Serum Concentrations of MOR106 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 Number of Participants With Anti-drug Antibodies (ADAs) Day 1 up to Day 169/ED
Trial Locations
- Locations (13)
Advanced Research Institute of Miami LLC
🇺🇸Homestead, Florida, United States
Marvel Research, LLC
🇺🇸Huntington Beach, California, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Greenwich Village Dermatology
🇺🇸New York, New York, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
LA Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
MedDerm Associates
🇺🇸San Diego, California, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Vista Health Research
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States