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Trial record 2 of 3 for:    MOR106

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03689829
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

The clinical study consists of two parts:

  • Part 1 with healthy volunteers.
  • Part 2 including subjects with moderate to severe atopic dermatitis (a skin disease).

For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous).

For Part 2 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.


Condition or disease Intervention/treatment Phase
Healthy Atopic Dermatitis Drug: MOR106 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Part I - randomized open label. Part II - randomized double blind.
Primary Purpose: Basic Science
Official Title: A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: MOR106 Single Dose A, i.v. infusion, Part I
A single dose of MOR106 will be administered by i.v. infusion.
Drug: MOR106
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 interleukin-17C (IL-17C).

Experimental: MOR106 Single Dose B, s.c. injection, Part I
A single dose of MOR106 will be administered by s.c. injection.
Drug: MOR106
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 interleukin-17C (IL-17C).

Experimental: MOR106 Single Dose C, s.c. injection, Part I
A single dose of MOR106 will be administered by s.c. injection.
Drug: MOR106
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 interleukin-17C (IL-17C).

Experimental: MOR106 Single Dose D, s.c. injection, Part I
A single dose of MOR106 will be administered by s.c. injection.
Drug: MOR106
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 interleukin-17C (IL-17C).

Experimental: MOR106 Repeated Doses E, s.c. injection, Part II
Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration.
Drug: MOR106
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 interleukin-17C (IL-17C).

Placebo Comparator: Placebo s.c.injection, Part II
Corresponding Placebo will be administered by s.c. injection in Part II.
Drug: Placebo
Corresponding placebo s.c. injections.




Primary Outcome Measures :
  1. The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part I. [ Time Frame: From study drug administration until Day 50 postdose or early discontinuation (ED) visit ]
    To evaluate the safety and tolerability of single doses of MOR106 administered s.c. in comparison to i.v.

  2. The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part II. [ Time Frame: From study drug administration until Day 197 postdose or early discontinuation (ED) visit ]
    To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.

  3. AUC ratio between s.c. and i.v. dosing (area under the plasma concentration-time curve) Part I. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To determine the relative bioavailability following sc route of administration.

  4. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) Part I. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the pharmacokinetics (PK) of MOR106.

  5. Terminal elimination half-life (t1/2) Part I. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the PK of MOR106.

  6. Maximum observed plasma concentration (Cmax) Part I. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the PK of MOR106.


Secondary Outcome Measures :
  1. Occurrence of anti-drug antibodies (ADA) Part I. [ Time Frame: From baseline through Day 50 postdose or early discontinuation (ED) visit ]
    To monitor the occurrence of ADA after single administrations of MOR106.

  2. Occurrence of anti-drug antibodies (ADA) Part II. [ Time Frame: From baseline through Day 197 postdose or early discontinuation (ED) visit ]
    To monitor the occurrence of ADA after multiple administrations of MOR106.

  3. MOR106 serum concentrations after multiple s.c. administrations Part II. [ Time Frame: Between Day 1 study period and Day 197 postdose or early discontinuation (ED) visit ]
    Steady-state will be assessed using MOR106 serum concentrations.

  4. Percent change in Eczema Area and Severity Index (EASI) Part II. [ Time Frame: From baseline to Day 85 ]
    To assess the efficacy of MOR106 by use of EASI score. 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 Part II. [ Time Frame: From baseline to Day 85 ]
    To assess the efficacy of MOR106 by use of EASI score. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  6. Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part II. [ Time Frame: From baseline to Day 85 ]
    To assess the efficacy of MOR106 by use of EASI score. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.

  7. Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part II. [ Time Frame: From baseline to Day 85 ]
    To assess the efficacy of MOR106 by use of EASI score,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 Part II. [ Time Frame: at Day 85 visit ]
    To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.

  9. Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part II. [ Time Frame: at Day 85 visit ]
    To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.

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

  11. Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part II. [ Time Frame: From baseline to Day 85 ]
    To assess the efficacy of MOR106 by use of POEM. The POEM is calculated by summing the score of each question resulting in a maximum score of 28 and a minimum score of 0.

  12. Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part II. [ Time Frame: From screening until Day 197 or early discontinuation (ED) visit twice daily ]
    To assess the efficacy of MOR106 by NRS. An 11-point (0 - 10) scale will be used to assess itch (pruritus). 0 being 'no itch' and 10 being the 'worst itch imaginable'.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part 1:

  • Male between 18-50 years of age (extremes included), on the day of signing the informed consent form (ICF).
  • Subjects between 65-88 kg (extremes included) with a body mass index (BMI) between 18-30 kg/m², inclusive.
  • Judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and screening laboratory profile prior to the initial investigation medicinal product (IMP) administration.

Part 2:

  • Male or female between 18-65 years of age (extremes included), on the day of signing ICF.
  • A BMI between 18-30 kg/m², inclusive.
  • Diagnosis of AD for at least one year since first diagnosis as per Hanifin and Rajka Criteria.
  • EASI ≥ 12 at screening and ≥ 16 at the baseline visit (Day 1 predose)
  • ≥ 10% BSA of AD involvement at screening.
  • IGA score ≥ 3 (on 0-4 IGA scale).
  • Willingness to use an additive free, basic, bland emollient twice daily for at least seven days before the baseline visit and throughout the study
  • Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids (TCS) and / or topical calcineurin inhibitors (TCI), per investigator's judgment.

Exclusion Criteria:

Part 1 and Part 2:

  • Known hypersensitivity to IMP ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).
  • Prior treatment with MOR106.
  • 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 three 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.
  • History of, or current immunosuppressive condition.

Part 2:

  • 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 1 week before baseline (Day 1 pre-dose).
  • Prior treatment with MOR106.
  • Having used any of the following treatments:

    i). Exposure to a biologic therapy for AD. ii) Immunosuppressive/ immunomodulating drugs (e.g. systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-γ (IFN-γ), azathioprine, methotrexate, etc.) within 4 weeks of baseline. iii) Phototherapy (ultraviolet (UVB) or Psoralen Ultraviolet A [PUVA]) for AD within four weeks of baseline. iv) Treatment with TCS or TCI within two weeks before the baseline visit. v) Treatment with biologics (for non-AD indications) within five half-lives (if known) or 12 weeks prior to baseline visit, whichever is longer. vi) Regular use (more than two visits per week) of a tanning booth/parlor within four weeks of the screening 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): NCT03689829


Contacts
Contact: Evelyn Fox 0032 15 34 29 00 evelyn.fox@glpg.com
Contact: Helen Timmis, MB CHB

Locations
United Kingdom
MEU Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03689829     History of Changes
Other Study ID Numbers: MOR106-CL-102
2018-000357-44 ( EudraCT Number )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 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