Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    MOR106

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 (GECKO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864627
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : September 23, 2019
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 subjects 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
Experimental: MOR106 and TCS
Repeated s.c. doses of MOR106, administered concomitantly with TCS (medium potency). On Day 1 a loading dose (LD) will be administered.
Drug: MOR106
MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Placebo Comparator: Placebo and TCS
Repeated s.c. doses of placebo, administered concomitantly with TCS (medium potency). On Day 1 a loading dose (LD) will be administered (placebo).
Drug: Placebo
Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).




Primary Outcome Measures :
  1. The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: From screening up through Day 169 or early discontinuation (ED) visit ]
    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.


Secondary Outcome Measures :
  1. MOR106 serum concentrations after repeated s.c. administrations [ Time Frame: From baseline through Day 169 or ED visit ]
    To evaluate the pharmacokinetics (PK) of repeated s.c. doses of MOR106 administered concomitantly with TCS.

  2. Occurrence of anti-drug antibodies (ADA) [ Time Frame: From baseline through Day 169 or ED visit ]
    To monitor the occurrence ADA as a measure of immunogenicity after repeated s.c. doses of MOR106 administered concomitantly with TCS.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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


Contacts
Layout table for location contacts
Contact: Galapagos Medical Information +32 15 342900 medicalinfo@glpg.com

Locations
Layout table for location information
United States, California
First OC Dermatology Recruiting
Fountain Valley, California, United States, 92708
Center for Dermatology Clinical Research, Inc. Recruiting
Fremont, California, United States, 94538
Advanced Skincare Surgery & Med Center Recruiting
Fullerton, California, United States, 92835
Marvel Research, LLC Recruiting
Huntington Beach, California, United States, 92647
LA Universal Research Center, Inc. Recruiting
Los Angeles, California, United States, 90057
MedDerm Associates Recruiting
San Diego, California, United States, 92103
Clinical Science Institute Withdrawn
Santa Monica, California, United States, 90404
United States, Florida
Encore Medical Research Recruiting
Hollywood, Florida, United States, 33021
Advanced Research Institute of Miami LLC Recruiting
Homestead, Florida, United States, 33030
Finlay Medical Research Recruiting
Miami, Florida, United States, 33126
Vista Health Research Recruiting
Miami, Florida, United States, 33185
United States, Georgia
Mt. Vernon Clinical Research Withdrawn
Duluth, Georgia, United States, 30097
United States, Illinois
University of Dermatology and Vein Clinic Recruiting
Chicago, Illinois, United States, 60640
Arlington Dermatology Recruiting
Rolling Meadows, Illinois, United States, 60008
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC Recruiting
Indianapolis, Indiana, United States, 46250
United States, Kentucky
DS Research Recruiting
Louisville, Kentucky, United States, 40241
United States, Michigan
Great Lakes Research Group, Inc Recruiting
Bay City, Michigan, United States, 78216
United States, New York
Greenwich Village Dermatology Recruiting
New York, New York, United States, 10012
United States, Ohio
Remington-Davis, Inc. Clinical Research Recruiting
Columbus, Ohio, United States, 43215
United States, Pennsylvania
KGL LLC Recruiting
Broomall, Pennsylvania, United States, 19008
United States, Texas
Center for Clinical Studies Recruiting
Houston, Texas, United States, 77004
Progressive Clinical Research Recruiting
San Antonio, Texas, United States, 78229
Center for Clinical Studies Recruiting
Webster, Texas, United States, 77598
Canada, Newfoundland and Labrador
NewLab Clinical Research, Inc. Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1C2H5
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Helen Timmis, MB CHB Galapagos NV

Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03864627     History of Changes
Other Study ID Numbers: MOR106-CL-204
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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