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A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis (GECKO)

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ClinicalTrials.gov Identifier: NCT03864627
Recruitment Status : Terminated (MOR106 clinical development in atopic dermatitis was stopped for futility)
First Posted : March 6, 2019
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: MOR106 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : February 27, 2020
Actual Study Completion Date : February 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
Placebo Comparator: 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.
Drug: Placebo
Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Experimental: MOR106 320 mg
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.
Drug: MOR106
MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) [ Time Frame: 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 :
  1. Serum Concentrations of MOR106 [ Time Frame: 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 ]
  2. Number of Participants With Anti-drug Antibodies (ADAs) [ Time Frame: Day 1 up to Day 169/ED ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864627


Locations
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United States, California
First OC Dermatology
Fountain Valley, California, United States, 92708
Marvel Research, LLC
Huntington Beach, California, United States, 92647
LA Universal Research Center, Inc.
Los Angeles, California, United States, 90057
MedDerm Associates
San Diego, California, United States, 92103
United States, Florida
Encore Medical Research
Hollywood, Florida, United States, 33021
Advanced Research Institute of Miami LLC
Homestead, Florida, United States, 33030
Vista Health Research
Miami, Florida, United States, 33185
United States, Illinois
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
United States, Kentucky
DS Research
Louisville, Kentucky, United States, 40241
United States, New York
Greenwich Village Dermatology
New York, New York, United States, 10012
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77004
Progressive Clinical Research
San Antonio, Texas, United States, 78229
Center for Clinical Studies
Webster, Texas, United States, 77598
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Galapagos Medical Information Galapagos NV
  Study Documents (Full-Text)

Documents provided by Galapagos NV:
Study Protocol  [PDF] June 25, 2019
Statistical Analysis Plan  [PDF] March 12, 2020

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03864627    
Other Study ID Numbers: MOR106-CL-204
First Posted: March 6, 2019    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases