A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

NCT04791319 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1089322020-002587-3177474462ADM2001
• Study Type: interventional
• Target: 199
• Locations: 5 countries
• Sites: 42

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16

  Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

  Week 16

Secondary Outcomes (7)

• Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16

  Week 16

• Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4

  Week 16

• Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16

  Week 16

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Up to Week 36

• Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

  Up to Week 36

Study Arms (4)

Group 1: Placebo

PLACEBO COMPARATOR

Participants will receive subcutaneous (SC) placebo once a week (qw) through Week 15. At Week 16, participants will crossover to receive SC bermekimab Dose 2 qw through Week 31.

Drug: Placebo; Drug: Bermekimab

Group 2: Bermekimab

EXPERIMENTAL

Participant will receive SC bermekimab Dose 1 qw from Week 0 through Week 31.

Drug: Bermekimab

Group 3: Bermekimab

EXPERIMENTAL

Participants will receive SC bermekimab Dose 2 qw from Week 0 through Week 15. At Week 16, participants who achieve an eczema area and severity index (EASI)-75 response (responders) will be rerandomized either to continue to receive bermekimab Dose 2 qw, or to receive bermekimab Dose 1 qw, through Week 31 and participants who do not achieve an EASI-75 response (non responders) will continue to receive bermekimab Dose 2 qw through Week 31.

Drug: Bermekimab

Group 4: Dupilumab

ACTIVE COMPARATOR

Participants will receive a loading dose of SC dupilumab Dose 1 at Week 0, SC placebo every two week (q2w) from Week 1 through Week 15 and then dupilumab Dose 2 q2w from Week 2 through Week 14. At Week 16, participants who achieve EASI-75 response (dupilumab responders) will continue on dupilumab Dose 2 q2w through Week 30 and placebo q2w from Week 17 through Week 31. Participants who do not achieve an EASI-75 response (dupilumab non-responders) will receive placebo qw from Week 16 through Week 18 (washout period) and bermekimab Dose 2 qw from Week 19 through Week 31.

Drug: Placebo; Drug: Bermekimab; Drug: Dupilumab

Interventions

Placebo DRUG

Placebo will be administered subcutaneously.

Group 1: Placebo; Group 4: Dupilumab

Bermekimab DRUG

Bermekimab will be administered subcutaneously.

Also known as: JNJ-77474462

Group 1: Placebo; Group 2: Bermekimab; Group 3: Bermekimab; Group 4: Dupilumab

Dupilumab DRUG

Dupilumab will be administered subcutaneously.

Group 4: Dupilumab

Eligibility Criteria

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

You may qualify if:

• Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
• Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example \[eg\], due to important side effects or safety risks)
• Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
• Have an eczema area and severity index (EASI) score greater than or equal (\>=) to 16 at screening and at baseline
• Have an investigator global assessment (IGA) score \>=3 and involved body surface area (BSA) \>=10 percent (%) at screening and baseline

You may not qualify if:

• Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
• Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
• Has or has had herpes zoster within the 2 months before screening
• Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (42)

California Allergy & Asthma Medical Group Inc.

Los Angeles, California, 90025, United States

Location

Wolverine Clinical Trials

Santa Ana, California, 92705, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Forcare Clinical Research, Inc.

Tampa, Florida, 33613, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Ohio State University

Columbus, Ohio, 43215, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners

Johnston, Rhode Island, 02919, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23502, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Allergy Research Canada Inc.

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2H2B5, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitan

Québec, Quebec, G1V 4X7, Canada

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Goethe Universität Frankfurt

Frankfurt am Main, 60590, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20537, Germany

Location

MensingDerma research GmbH

Hamburg, 22391, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Praxis Dr. med. Beate Schwarz - Germany

Langenau, 89129, Germany

Location

Hautarztpraxis

Mahlow, 15831, Germany

Location

Takagi Clinic

Obihiro-shi, 080-0013, Japan

Location

Kume Clinic

Osaka Fu, 593-8324, Japan

Location

Sapporo Skin Clinic

Sapporo, 060-0063, Japan

Location

Nzoz Przychodnia Specjalistyczna Medica

Częstochowa, 42-200, Poland

Location

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, 90-242, Poland

Location

DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

Osielsko, 86031, Poland

Location

Klinika Ambroziak Estederm Sp. z o.o

Warsaw, 02-953, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02962, Poland

Location

Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, 50566, Poland

Location

WroMedica I.Bielicka, A.Strzałkowska s.c.

Wroclaw, 51-685, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

bermekimab; dupilumab

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

Results Point of Contact

• Title: Director Clinical Research Dermatology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 10, 2021
• Study Start: May 3, 2021
• Primary Completion: February 2, 2022
• Study Completion: March 31, 2022
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (7); DE (8); US (18); CA (6); JP (3)