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

Dermatitis, Atopic Clinical Trial

— GENESIS  

Official title:

A Phase 2b, Multicenter, Randomized, Placebo- and Active-comparator-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Participants With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04791319
• Other study ID #: CR108932
• Secondary ID: 2020-002587-3177
• Status: Terminated
• Phase: Phase 2
• Start date: May 3, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: March 31, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Placebo
Placebo will be administered subcutaneously.
• Bermekimab
Bermekimab will be administered subcutaneously.
• Dupilumab
Dupilumab will be administered subcutaneously.

Locations

Country	Name	City	State
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Allergy Research Canada Inc.	Niagara Falls	Ontario
Canada	Centre De Recherche Dermatologique Du Quebec Metropolitan	Quebec
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Goethe Universität Frankfurt	Frankfurt/ Main
Germany	MensingDerma research GmbH	Hamburg
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis Dr. med. Beate Schwarz - Germany	Langenau
Germany	Hautarztpraxis	Mahlow
Japan	Takagi Clinic	Obihiro-shi
Japan	Kume Clinic	Osaka Fu
Japan	Sapporo Skin Clinic	Sapporo
Poland	Nzoz Przychodnia Specjalistyczna Medica	Czestochowa
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz
Poland	DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.	Osielsko
Poland	Klinika Ambroziak Estederm Sp. z o.o	Warszawa
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska	Wroclaw
Poland	WroMedica I.Bielicka, A.Strzalkowska s.c.	Wroclaw
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Ohio State University	Columbus	Ohio
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Clinical Partners	Johnston	Rhode Island
United States	California Allergy & Asthma Medical Group Inc.	Los Angeles	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Progressive Clinical Research	San Antonio	Texas
United States	Wolverine Clinical Trials	Santa Ana	California
United States	Premier Clinical Research	Spokane	Washington
United States	Forcare Clinical Research, Inc.	Tampa	Florida
United States	Grekin Skin Institute	Warren	Michigan
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD.	Week 16
Secondary	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	Percentage of participants with improvement (reduction from baseline) in eczema-related itch NRS of score >=4 at Week 16 among participants with a baseline itch value >=4 were reported. The eczema skin pain and Itch NRS is a 2-item patient-reported outcome that participants used to rate the severity of their eczema-related skin pain and eczema related itch daily. Participants were asked the following questions: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours; and please rate the severity of your eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible" and were scored separately. Higher score indicated more severity.	Week 16
Secondary	Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16	Percentage of participants achieving EASI-90 at Week 16 were reported. EASI-90 response is defined as at least 90% 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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were AEs with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline. AEs are presented by individual dose received by participants during placebo-controlled period and by responders individual dose received during active treatment period.	Up to Week 36
Secondary	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline was considered to be TESAEs. AEs are presented by individual dose received by participants during placebo-controlled period and active treatment period.	Up to Week 36
Secondary	Serum Bermekimab Concentration Over Time	Serum bermekimab concentration over time were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.	Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36
Secondary	Number of Participants With Anti-Bermekimab Antibodies	Number of participants with anti-bermekimab antibodies were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.	Up to Week 36