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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

2020. március 16. frissítette: Galapagos NV

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)

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.

A tanulmány áttekintése

Állapot

Megszűnt

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

44

Fázis

  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

      • Manchester, Egyesült Királyság
        • MEU
      • Northwood, Egyesült Királyság, HA6 2RN
        • MeDiNova North London
      • Romford, Egyesült Királyság, RM1 3PJ
        • MeDiNova East London
      • Sidcup, Egyesült Királyság, DA14 6LT
        • MeDiNova South London
      • Augsburg, Németország, 86179
        • Klinikum Augsburg Süd
      • Dessau, Németország, 06847
        • Municipal Hospital Dessau
      • Dresden, Németország, 1307
        • University Hospital Carl Gustav Carus
      • Erlangen, Németország, 91054
        • University Hospital Erlangen, Department of Dermatology
      • Magdeburg, Németország, 39120
        • Medical Faculty University Clinic Magdeburg, University dermatology clinic
      • Recklinghausen, Németország, 45657
        • Vest Clinic, Department of Dermatology and Allergy
      • Alicante, Spanyolország, 03010
        • Hospital General Universitario de Alicante
      • Madrid, Spanyolország, 28034
        • Hospital Ramon Y Cajal
      • Sevilla, Spanyolország, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spanyolország, 46014
        • Hospital General Universitario de Valencia
      • Kapitanivka, Ukrajna, 08112
        • ARENSIA

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Alapvető tudomány
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: MOR106 Single Dose A, i.v. infusion, Part 1
A single dose of MOR106 will be administered by i.v. infusion.
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).
Kísérleti: MOR106 Single Dose B, s.c. injection, Part 1
A single dose of MOR106 will be administered by s.c. injection.
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).
Kísérleti: MOR106 Single Dose C, s.c. injection, Part 1
A single dose of MOR106 will be administered by s.c. injection.
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).
Kísérleti: MOR106 Single Dose D, s.c. injection, Part 1
A single dose of MOR106 will be administered by s.c. injection.
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).
Kísérleti: 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.
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 2
Corresponding Placebo will be administered by s.c. injection.
Corresponding placebo s.c. injections.
Kísérleti: 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.
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 3
Corresponding Placebo will be administered by s.c. injection.
Corresponding placebo s.c. injections.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
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.
Időkeret: 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.
From study drug administration until Day 50 postdose or early discontinuation (ED) visit
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.
Időkeret: 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.
From study drug administration until Day 197 postdose or early discontinuation (ED) visit
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.
Időkeret: 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.
From study drug administration until Day 155 postdose or early discontinuation (ED) visit
AUC ratio between s.c. and i.v. dosing (area under the plasma concentration-time curve) Part 1.
Időkeret: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To determine the relative bioavailability following sc route of administration.
Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) Part 1.
Időkeret: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the pharmacokinetics (PK) of MOR106.
Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Terminal elimination half-life (t1/2) Part 1.
Időkeret: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the PK of MOR106.
Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Maximum observed plasma concentration (Cmax) Part 1.
Időkeret: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the PK of MOR106.
Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Occurrence of anti-drug antibodies (ADA) Part 1.
Időkeret: From baseline through Day 50 postdose or early discontinuation (ED) visit
To monitor the occurrence of ADA after single administrations of MOR106.
From baseline through Day 50 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 2.
Időkeret: From baseline through Day 197 postdose or early discontinuation (ED) visit
To monitor the occurrence of ADA after multiple administrations of MOR106.
From baseline through Day 197 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 3.
Időkeret: From baseline through Day 155 postdose or early discontinuation (ED) visit
To monitor the occurrence of ADA after multiple administrations of MOR106.
From baseline through Day 155 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 2.
Időkeret: Between Day 1 study period and Day 197 postdose or early discontinuation (ED) visit
Steady-state will be assessed using MOR106 serum concentrations.
Between Day 1 study period and Day 197 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 3.
Időkeret: Between Day 1 study period and Day 155 postdose or early discontinuation (ED) visit
Steady-state will be assessed using MOR106 serum concentrations.
Between Day 1 study period and Day 155 postdose or early discontinuation (ED) visit
Percent change in Eczema Area and Severity Index (EASI) Part 2.
Időkeret: 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.
From baseline to Day 85
Percent change in Eczema Area and Severity Index (EASI) Part 3.
Időkeret: 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.
From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 2.
Időkeret: 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.
From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 3.
Időkeret: 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.
From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 2.
Időkeret: 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.
From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 3.
Időkeret: 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.
From baseline to Day 85
Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 2.
Időkeret: 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.
From baseline to Day 85
Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 3.
Időkeret: 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.
From baseline to Day 85
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 2.
Időkeret: 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.
at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 3.
Időkeret: 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.
at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 2.
Időkeret: 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.
at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 3.
Időkeret: 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.
at Day 85 visit
Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 2.
Időkeret: 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.
From baseline to Day 85
Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 3.
Időkeret: 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.
From baseline to Day 85
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 2.
Időkeret: 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.
From baseline to Day 85
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 3.
Időkeret: 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.
From baseline to Day 85
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 2.
Időkeret: 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'.
From screening until Day 197 or early discontinuation (ED) visit twice daily
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 3.
Időkeret: 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'.
From screening until Day 155 or early discontinuation (ED) visit twice daily

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Nyomozók

  • Tanulmányi igazgató: Helen Timmis, MB CHB, Galapagos NV

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2018. augusztus 13.

Elsődleges befejezés (Tényleges)

2020. március 2.

A tanulmány befejezése (Tényleges)

2020. március 2.

Tanulmányi regisztráció dátumai

Először benyújtva

2018. szeptember 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2018. szeptember 26.

Első közzététel (Tényleges)

2018. szeptember 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. március 18.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. március 16.

Utolsó ellenőrzés

2020. március 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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Klinikai vizsgálatok a Egészséges

Klinikai vizsgálatok a MOR106

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