A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis

NCT ID: NCT03864627

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-02-27

Brief Summary

To investigate the safety and tolerability of repeated subcutaneous (s.c.) doses of MOR106 administered concomitantly with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Placebo

Participants will receive MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

MOR106 320 mg

Participants will receive MOR106 320 milligrams (mg) via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency topical TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection will be administered on Day 1.

Group Type: EXPERIMENTAL

MOR106

Intervention Type: DRUG

MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Interventions

MOR106

MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Intervention Type: DRUG

Placebo

Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A BMI 18 - 40 kilogram per meter square (kg/m^2), inclusive.
• Diagnosis of atopic dermatitis for at least one year since first diagnosis as per the Hanifin and Rajka Criteria.
• Eczema Area and Severity Index (EASI) ≥ 16 at the screening and at the baseline visit (Day 1 predose).
• Investigators' Global Assessment (IGA) score ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits.
• Greater than or equal to 10% body surface area (BSA) of AD involvement at the screening and baseline visits.
• Willingness to use a non-medicated, simple bland emollient twice daily for at least 7 days before the baseline visit and throughout the study.

Exclusion Criteria

• Prior treatment with MOR106.
• Known hypersensitivity to any investigational medicinal product (IMP) ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).
• AD lesions located predominantly (≥ 50% of cumulative lesional area) on face and genital areas.
• Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, a New York Heart Association Classification (NYHA) ≥ III/IV) or clinically significant illness in the 3 months prior to initial IMP administration that, in the investigator's opinion, represents a safety risk for the participant's participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the participant from safely completing the assessments required by the protocol.
• Clinically significant abnormalities at the discretion of the investigator detected on vital signs or physical examination (other than AD) at screening or baseline (Day 1 predose).
• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, as determined by a positive HIV test at screening).
• 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 7 days before baseline (Day 1 pre-dose).
• Having used any of the following treatments:

• Prior exposure to Dupilumab.
• Immunosuppressive/immunomodulating drugs (e.g. systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon (IFN)-γ, azathioprine, methotrexate) within 4 weeks of baseline (Day 1) visit.
• Phototherapy (ultraviolet B [UVB] or Psoralen Ultraviolet A [PUVA]) for AD within four weeks of baseline (Day 1) visit.
• Treatment with TCS or topical calcineurin inhibitor (TCI) within 7 days before the baseline (Day 1) visit.
• Treatment with biologics within five half-lives (if known) or 12 weeks prior to baseline visit, whichever is longer.
• Regular use (more than two visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit.

• 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

Galapagos Medical Information

Role: STUDY_DIRECTOR

Galapagos NV

Locations

First OC Dermatology

Fountain Valley, California, United States

Marvel Research, LLC

Huntington Beach, California, United States

LA Universal Research Center, Inc.

Los Angeles, California, United States

MedDerm Associates

San Diego, California, United States

Encore Medical Research

Hollywood, Florida, United States

Advanced Research Institute of Miami LLC

Homestead, Florida, United States

Vista Health Research

Miami, Florida, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

DS Research

Louisville, Kentucky, United States

Greenwich Village Dermatology

New York, New York, United States

Center for Clinical Studies

Houston, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MOR106-CL-204

Identifier Type: -

Identifier Source: org_study_id