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A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03568071
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed as a treatment for diseases such as psoriasis and atopic dermatitis. An antibody is a protein that is made by the body in a defense reaction against viruses and bacteria or other small particles. In this case, MOR106 will act against IL-17C interleukin by binding to it. This way it could be possible to act against these diseases.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: MOR 106 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cohort A - dose regimen A
MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen A) will be administered on Day 1.
Drug: MOR 106
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Experimental: Cohort B - dose regimen B
MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen B) will be administered on Day 1.
Drug: MOR 106
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Experimental: Cohort C - dose regimen C
MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen C) will be administered on Day 1.
Drug: MOR 106
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Experimental: Cohort D - dose regimen D
MOR106 will be administered as IV infusion. Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period. A loading dose (dose regimen D) will be administered on Day 1.
Drug: MOR 106
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Experimental: Cohort E - dose regimen E
MOR106 will be administered as IV infusion.Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period.. A loading dose (dose regimen E) will be administered on Day 1.
Drug: MOR 106
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Placebo Comparator: Placebo
Subjects will receive repeated doses of placebo over a 12-week treatment period.
Drug: Placebo
A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.




Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) score. [ Time Frame: From baseline to Day 85 ]
    To assess the clinical efficacy of repeated IV doses of MOR106 as assessed by percentage change from baseline in EASI score at Day 85 visit. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.


Secondary Outcome Measures :
  1. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: From baseline to Day 85 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  2. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 1 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  3. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 15 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  4. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 29 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  5. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 43 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  6. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 57 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  7. Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score. [ Time Frame: At Day 71 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  8. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 85 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  9. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 1 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  10. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 15 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  11. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 29 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  12. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 43 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  13. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 57 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  14. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1. [ Time Frame: At Day 71 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  15. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 85 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  16. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 1 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  17. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 15 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  18. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 29 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  19. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 43 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  20. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 57 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  21. Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2. [ Time Frame: At Day 71 ]
    To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  22. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: From baseline to Day 85 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  23. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 1 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  24. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 15 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  25. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 29 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  26. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 43 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  27. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 57 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  28. Percent change in Scoring Atopic Dermatitis (SCORAD) score. [ Time Frame: At Day 71 ]
    To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.

  29. The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs). [ Time Frame: From screening up to Day 197/early discontinuation (ED) visit ]
    To assess the safety and tolerability of repeated IV doses of MOR106.

  30. Characterization of the MOR106 immunogenetic profile. [ Time Frame: From baseline through Day 197/ED visit ]
    To assess the immunogenicity of repeated IV doses of MOR106.

  31. MOR106 (AUC0-inf) [ Time Frame: From baseline through Day 197/ED visit ]
    To characterize the PK of repeated IV doses of MOR106.



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.


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 informed consent form (ICF).
  • Able and willing to give voluntary written informed consent and meet all of the inclusion criteria and none of the exclusion criteria before being enrolled in the study. The subjects must sign the informed consent form prior to any study-related procedures and agree to the schedule of assessments.
  • A body mass index (BMI) between ≥18 and ≤30 kg/m².
  • Diagnosis of chronic atopic dermatitis with at least 1 year since first diagnosis, as per the Hanifin and Rajka Criteria, fulfilling the following criteria:

    1. EASI ≥12 at screening and ≥16 at baseline (Day 1 pre-dose).
    2. Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and at baseline.
    3. Greater than or equal to 10% body surface area (BSA) of atopic dermatitis involvement at screening.
    4. Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before baseline and throughout the study.
    5. Subject is a candidate for systemic therapy and has a history of inadequate response or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors before screening visit, as per investigator's opinion.
  • Willing to adhere to the following contraceptive restrictions:

    1. Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline.
    2. Female subjects of childbearing potential must use a highly effective method of contraception from 28 days prior to the first dose of study drug, during the study, and for at 3 months after the last dose of study drug.
    3. Non-vasectomized male subjects with a female partner of childbearing potential must agree to a highly effective form of contraception during the study, and for at least 3 months after last dose of study drug.
    4. All male subjects must agree to use a condom from the first dose of Investigational Medicinal Product (IMP), during the study and for at least 3 month after the last dose of IMP.

Exclusion Criteria:

  • Known hypersensitivity to study drug ingredients or history of any significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
  • Prior treatment with MOR106.
  • Positive serology for hepatitis B (positive hepatitis B core antibody (HBc) or hepatitis C virus (HCV) antibody or any history of hepatitis from any cause with the exception of hepatitis A. Subjects who are immune to hepatitis B because of vaccination can be included.
  • History of or current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection), including history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
  • Subjects with a history of Varicella zoster virus/≥ one episode of Herpes Zoster or Herpes Zoster within 1 year of screening must be excluded. (A history of Herpes simplex types 1 and 2 and vaginal candidiasis are permitted.)
  • Current active, latent or history of tuberculosis (TB) infection, based on medical history and as determined by a positive QuantiFERON TB Gold test at screening. (For indeterminate results, one retest is permitted. If a subject remains indeterminate following the repeat test they must be excluded).
  • Pregnant or breast feeding female or subject is intending to become pregnant or breastfeed.
  • Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, ≥ New York Heart Association Classification (NYHA) III/IV) or clinically significant illness in the 3 months prior to initial study drug 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.
  • Any of the following laboratory findings:

    1. White blood cell count <3.0 x 109 cells/L
    2. Neutrophil count <1.5 x 109 cells/L
    3. Platelet count <100 x 109 cells/L
    4. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN)
  • History of malignancy within the past 5 years prior to screening with the exception of non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or of the breast, prostate cancer T1a or T1b using the TNM (tumour, nodes, metastasis) clinical staging system.
  • Clinically significant abnormalities at the discretion of the investigator detected on vital signs or physical examination (other than atopic dermatitis) at screening or baseline (Day 1 pre-dose).
  • History of eczema herpeticum in the last 12 months prior to screening.
  • Subjects who have had an attenuated vaccination within 4 weeks of baseline or are expected to have one during the course of the study.
  • Participation in another experimental therapy study within 5 times the half-life (if known) or 12 weeks (if not known) of the experimental therapy, prior to baseline, or current enrollment in any other interventional study.
  • Having used any of the following treatments:

    1. Exposure to a biologic therapy for atopic dermatitis
    2. Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma, azathioprine, methotrexate) within 4 weeks of baseline
    3. Phototherapy (ultraviolet [UV] B or psoralen and ultraviolet A [PUVA]) for atopic dermatitis within 4 weeks of baseline
    4. Treatment with topical corticosteroids or topical calcineurin inhibitors within 2 weeks of baseline
    5. Treatment with biologics (for non atopic dermatitis indications within 5 half-lives (if known) or 12 weeks prior to baseline (if unknown)
    6. Regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks of screening
  • Active chronic or acute infection requiring treatment with systemic (oral, SC or IV) antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals, within 4 weeks of baseline, or clinical signs of infective eczema within 1 week before baseline. Note: subjects may be rescreened after infection resolves.
  • Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.
  • Not able to manage the electronic diary (e-diary) as per assessment of the investigator.

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): NCT03568071


Contacts
Contact: Evelyn Fox 0032 15 34 29 00 evelyn.fox@glpg.com

  Show 44 Study Locations
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Helen Timmis, MBChB MICR Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03568071     History of Changes
Other Study ID Numbers: MOR106-CL-201
2017-001142-10 ( EudraCT Number )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases