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

NCT ID: NCT03568071

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2020-03-03

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

MOR 106

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MOR 106

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MOR 106

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MOR 106

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MOR 106

Intervention Type: DRUG

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

Subjects will receive repeated doses of placebo over a 12-week treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF).
• 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 least 24 weeks 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 24 weeks 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 24 weeks 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 surface [HBs] antigen and/or positive hepatitis 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 who experienced any episode or recurrence of Herpes Zoster infection within 1 year of screening or ≥ one episode 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.)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Timmis, MBChB MICR

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Fachklinik Bad Bentheim, Department of Dermatology

Bad Bentheim, , Germany

Korsearch. Studienzentrum

Berlin, , Germany

Charite, Universitätsmedizin Berlin, Centrum 12, Klinik für Dermatologie, Venerologie und Allergologie

Berlin, , Germany

Hautarztpraxis im Jahrhunderthaus

Bochum, , Germany

Hauttumorzentrum Ruhr- Universität Bochum

Bochum, , Germany

RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie

Bochum, , Germany

Elbe Klinikum Buxtehude

Buxtehude, , Germany

Universitätsklinikum Frankfurt, Klinik für Dermatologie

Frankfurt, , Germany

SCIderm GmbH (a company of TFS group)

Hamburg, , Germany

Universitätsklinikum Heidelberg, Hautklinik

Heidelberg, , Germany

Institut für Entzündungsmedizin

Lübeck, , Germany

Clinical research center (CRC), Department of Dermatology

Mainz, , Germany

Technical University Munich, Department of Dermatology

Munich, , Germany

Klinik und Poliklinik der Dermatologie und Allergologie der Universität München

München, , Germany

University Hospital of Muenster, Dpt. of Dermatology

Münster, , Germany

Haut- und Lasercentrum Potsdam

Potsdam, , Germany

Budai Irgalmasrendi Kórház (St. John Hospital)

Budapest, , Hungary

Semmelweis Egyetem Bőrgyógyászati Klinika

Budapest, , Hungary

Bács-Kiskun Megyei Kórház Bőrgyógyászati Osztály

Kecskemét, , Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, , Hungary

Szegedi Egyetem Bőrgyógyászati és Allergológiai Klinika

Szeged, , Hungary

CERMED

Bialystok, , Poland

Antoni Jurasz Universiti Hospital Nº1

Bydgoszcz, , Poland

NZOZ Centrum Medyczne KERmed

Bydgoszcz, , Poland

A-DERM-SERWIS NZOZ , Przychodnia Specjalistyczna

Częstochowa, , Poland

Centrum Badań Klinicznych PI-House

Gdansk, , Poland

Gyncentrum

Katowice, , Poland

Centrum Medyczne ALL-MED

Krakow, , Poland

Diamond Clinic

Krakow, , Poland

Medical Center Dietla 19

Krakow, , Poland

NZOZ Centrum Medyczne proMimed

Krakow, , Poland

ETG Łódź

Lodz, , Poland

Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Lublin, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej

Lublin, , Poland

Labderm sc Beata Bergler-Czop Barbara Sido-Bergler

Ossy, , Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , Poland

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, , Poland

KLIMED Marek Klimkiewicz

Piotrkow Trybunalski, , Poland

Centrum Badan Klinicznych S.C.

Poznan, , Poland

Centrum Medyczne Grunwald

Poznan, , Poland

Clinical Research Center Sp. z o.o. Medic-R Spółka Komandytowa

Poznan, , Poland

ETG Skierniewice

Skierniewice, , Poland

Centrum Medyczne AMED

Warsaw, , Poland

Clinical Research Group

Warsaw, , Poland

ETG Warszawa

Warsaw, , Poland

4HEALTH

Wroclaw, , Poland

Dobrostan

Wroclaw, , Poland

KLIMED Marek Klimkiewicz

Łomża, , Poland

University Hospital Bratislava

Bratislava, , Slovakia

Whipps Cross Hospital

Leytonstone, , United Kingdom

Plymouth Hospitals NHS Trust

Plymouth, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, , United Kingdom

The Royal London Hospital

Whitechapel, , United Kingdom

Countries

Germany; Hungary; Poland; Slovakia; United Kingdom

Other Identifiers

2017-001142-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOR106-CL-201

Identifier Type: -

Identifier Source: org_study_id