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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 : Terminated (MOR106 clinical development in atopic dermatitis was stopped for futility)
First Posted : September 28, 2018
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE August 13, 2018
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • 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 1. [ 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.
  • 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 2. [ 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.
  • 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 3. [ Time Frame: From study drug administration until Day 155 postdose or early discontinuation (ED) visit ]
    To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.
  • AUC ratio between s.c. and i.v. dosing (area under the plasma concentration-time curve) Part 1. [ 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.
  • Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) Part 1. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the pharmacokinetics (PK) of MOR106.
  • Terminal elimination half-life (t1/2) Part 1. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the PK of MOR106.
  • Maximum observed plasma concentration (Cmax) Part 1. [ Time Frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit ]
    To characterize the PK of MOR106.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Occurrence of anti-drug antibodies (ADA) Part 1. [ Time Frame: From baseline through Day 50 postdose or early discontinuation (ED) visit ]
    To monitor the occurrence of ADA after single administrations of MOR106.
  • Occurrence of anti-drug antibodies (ADA) Part 2. [ Time Frame: From baseline through Day 197 postdose or early discontinuation (ED) visit ]
    To monitor the occurrence of ADA after multiple administrations of MOR106.
  • Occurrence of anti-drug antibodies (ADA) Part 3. [ Time Frame: From baseline through Day 155 postdose or early discontinuation (ED) visit ]
    To monitor the occurrence of ADA after multiple administrations of MOR106.
  • MOR106 serum concentrations after multiple s.c. administrations Part 2. [ 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.
  • MOR106 serum concentrations after multiple s.c. administrations Part 3. [ Time Frame: Between Day 1 study period and Day 155 postdose or early discontinuation (ED) visit ]
    Steady-state will be assessed using MOR106 serum concentrations.
  • Percent change in Eczema Area and Severity Index (EASI) Part 2. [ 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.
  • Percent change in Eczema Area and Severity Index (EASI) Part 3. [ 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.
  • Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 2. [ 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.
  • Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 3. [ 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.
  • Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 2. [ 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.
  • Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 3. [ 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.
  • Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 2. [ 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.
  • Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 3. [ 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.
  • Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 2. [ 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.
  • Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 3. [ 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.
  • Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 2. [ 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.
  • Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 3. [ 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.
  • Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 2. [ 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.
  • Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 3. [ 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.
  • Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 2. [ 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.
  • Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 3. [ 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.
  • Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 2. [ 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'.
  • Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 3. [ Time Frame: From screening until Day 155 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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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'.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
Brief Summary

The clinical study consists of three parts:

  • Part 1 with healthy volunteers.
  • Part 2 and Part 3 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 and Part 3 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Part 1 - randomized open label. Part 2 and Part 3 - randomized double blind.
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Atopic Dermatitis
Intervention  ICMJE
  • 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).
  • Drug: Placebo
    Corresponding placebo s.c. injections.
Study Arms  ICMJE
  • Experimental: MOR106 Single Dose A, i.v. infusion, Part 1
    A single dose of MOR106 will be administered by i.v. infusion.
    Intervention: Drug: MOR106
  • Experimental: MOR106 Single Dose B, s.c. injection, Part 1
    A single dose of MOR106 will be administered by s.c. injection.
    Intervention: Drug: MOR106
  • Experimental: MOR106 Single Dose C, s.c. injection, Part 1
    A single dose of MOR106 will be administered by s.c. injection.
    Intervention: Drug: MOR106
  • Experimental: MOR106 Single Dose D, s.c. injection, Part 1
    A single dose of MOR106 will be administered by s.c. injection.
    Intervention: Drug: MOR106
  • Experimental: MOR106 Repeated Doses E, s.c. injection, Part 2
    Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration.
    Intervention: Drug: MOR106
  • Placebo Comparator: Placebo s.c.injection, Part 2
    Corresponding Placebo will be administered by s.c. injection.
    Intervention: Drug: Placebo
  • Experimental: MOR106 Repeated Doses F, s.c. injection, Part 3
    Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration.
    Intervention: Drug: MOR106
  • Placebo Comparator: Placebo s.c.injection, Part 3
    Corresponding Placebo will be administered by s.c. injection.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 16, 2020)
44
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
77
Actual Study Completion Date  ICMJE March 2, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and Part 3:

  • 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, Part 2 and Part 3:

  • 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.

In addition for Part 2 and 3:

  • 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).
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Spain,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689829
Other Study ID Numbers  ICMJE MOR106-CL-102
2018-000357-44 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Helen Timmis, MB CHB Galapagos NV
PRS Account Galapagos NV
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP