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

NCT03568071 | Terminated Phase 2

• 2 other identifiers: MOR106-CL-2012017-001142-10
• Study Type: interventional
• Target: 207
• Locations: 5 countries
• Sites: 53

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

Outcome Measures

Primary Outcomes (1)

• Percent change in Eczema Area and Severity Index (EASI) score.

  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.

  From baseline to Day 85

Secondary Outcomes (31)

• Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.

  From baseline to Day 85

• Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.

  At Day 1

• Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.

  At Day 15

• Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.

  At Day 29

• Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.

  At Day 43

Study Arms (6)

Cohort A - dose regimen A

EXPERIMENTAL

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

Cohort B - dose regimen B

EXPERIMENTAL

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

Cohort C - dose regimen C

EXPERIMENTAL

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

Cohort D - dose regimen D

EXPERIMENTAL

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

Cohort E - dose regimen E

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MOR 106 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 A - dose regimen A; Cohort B - dose regimen B; Cohort C - dose regimen C; Cohort D - dose regimen D; Cohort E - dose regimen E

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF).

You may not qualify if:

• 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:
• EASI ≥12 at screening and ≥16 at baseline (Day 1 pre-dose).
• 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.
• Greater than or equal to 10% body surface area (BSA) of atopic dermatitis involvement at screening.
• 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.
• 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:
• Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (53)

Fachklinik Bad Bentheim, Department of Dermatology

Bad Bentheim, Germany

Location

Korsearch. Studienzentrum

Berlin, 13086, Germany

Location

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

Berlin, Germany

Location

Hautarztpraxis im Jahrhunderthaus

Bochum, Germany

Location

Hauttumorzentrum Ruhr- Universität Bochum

Bochum, Germany

Location

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

Bochum, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, Germany

Location

Universitätsklinikum Frankfurt, Klinik für Dermatologie

Frankfurt, Germany

Location

SCIderm GmbH (a company of TFS group)

Hamburg, Germany

Location

Universitätsklinikum Heidelberg, Hautklinik

Heidelberg, Germany

Location

Institut für Entzündungsmedizin

Lübeck, Germany

Location

Clinical research center (CRC), Department of Dermatology

Mainz, Germany

Location

Technical University Munich, Department of Dermatology

Munich, Germany

Location

Klinik und Poliklinik der Dermatologie und Allergologie der Universität München

München, Germany

Location

University Hospital of Muenster, Dpt. of Dermatology

Münster, Germany

Location

Haut- und Lasercentrum Potsdam

Potsdam, Germany

Location

Budai Irgalmasrendi Kórház (St. John Hospital)

Budapest, Hungary

Location

Semmelweis Egyetem Bőrgyógyászati Klinika

Budapest, Hungary

Location

Bács-Kiskun Megyei Kórház Bőrgyógyászati Osztály

Kecskemét, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, Hungary

Location

Szegedi Egyetem Bőrgyógyászati és Allergológiai Klinika

Szeged, Hungary

Location

CERMED

Bialystok, Poland

Location

Antoni Jurasz Universiti Hospital Nº1

Bydgoszcz, Poland

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

Location

A-DERM-SERWIS NZOZ , Przychodnia Specjalistyczna

Częstochowa, Poland

Location

Centrum Badań Klinicznych PI-House

Gdansk, Poland

Location

Gyncentrum

Katowice, Poland

Location

Centrum Medyczne ALL-MED

Krakow, Poland

Location

Diamond Clinic

Krakow, Poland

Location

Medical Center Dietla 19

Krakow, Poland

Location

NZOZ Centrum Medyczne proMimed

Krakow, Poland

Location

ETG Łódź

Lodz, Poland

Location

Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Lublin, Poland

Location

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

Lublin, Poland

Location

Labderm sc Beata Bergler-Czop Barbara Sido-Bergler

Ossy, 42-624, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Poland

Location

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, Poland

Location

KLIMED Marek Klimkiewicz

Piotrkow Trybunalski, 93-700, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, Poland

Location

Centrum Medyczne Grunwald

Poznan, Poland

Location

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

Poznan, Poland

Location

ETG Skierniewice

Skierniewice, Poland

Location

Centrum Medyczne AMED

Warsaw, Poland

Location

Clinical Research Group

Warsaw, Poland

Location

ETG Warszawa

Warsaw, Poland

Location

4HEALTH

Wroclaw, Poland

Location

Dobrostan

Wroclaw, Poland

Location

KLIMED Marek Klimkiewicz

Łomża, Poland

Location

University Hospital Bratislava

Bratislava, Slovakia

Location

Whipps Cross Hospital

Leytonstone, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

The Royal London Hospital

Whitechapel, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Helen Timmis, MBChB MICR

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 26, 2018
• Study Start: April 26, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

HU (5); DE (16); SL (1); PL (27); GB (4)