A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

NCT04021862 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10883377474462ADM2002
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 17

Brief Summary

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

Conditions

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16

  Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was 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 severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.

  Week 16

Secondary Outcomes (13)

• Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4

  Weeks 4, 8, 12, 16 and 32

• Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

  Weeks 4, 8, 12, 16 and 32

• Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

  Weeks 4, 8, 12, 16 and 32

• Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

  Weeks 4, 8, 12, 16 and 32

• Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32

  Weeks 4, 8, 12, and 32

Study Arms (3)

Treatment Arm 1 (bermekimab every week)

EXPERIMENTAL

Loading Dose: 400 mg subcutaneous (SC) injection of bermekimab and a SC injection of matching placebo at week 0 (Baseline). Treatment Dose: 400 mg subcutaneous injection of bermekimab administered weekly (qw) from week 1 through Week 31.

Drug: Bermekimab Monoclonal Antibody; Drug: Placebo

Treatment Arm 2 (bermekimab every other week)

EXPERIMENTAL

Loading Dose: 800 mg SC injection of bermekimab at week 0 (Baseline). Treatment Dose: 400 mg SC injection of bermekimab administered every other week (q2w) alternating with matching placebo q2w through Week 31.

Drug: Bermekimab Monoclonal Antibody; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Loading Dose: Placebo matching to bermekimab (4 milliliters \[mL\]) SC injection at Week 0, (Baseline). Treatment Dose: SC injection of matching placebo administered once weekly (qw) from week 1 to week 15 during placebo-controlled period. After completion of placebo-controlled period, participants will cross-over and receive bermekimab 400 mg SC injection qw at Week 16 through Week 31.

Drug: Placebo

Interventions

Bermekimab Monoclonal Antibody DRUG

Bermekimab 400 mg or 800 mg will be administered subcutaneously.

Treatment Arm 1 (bermekimab every week); Treatment Arm 2 (bermekimab every other week)

Placebo DRUG

Placebo will be administered subcutaneously.

Placebo; Treatment Arm 1 (bermekimab every week); Treatment Arm 2 (bermekimab every other week)

Eligibility Criteria

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

You may qualify if:

• Male or female, at least 18 years
• Willing and able to attend all clinic visits and comply with study-related procedures
• Participant can understand and complete study-related questionnaires
• Written informed consent provided by the participant
• Chronic atopic dermatitis present for at least 3 years
• Eczema Area and Severity Index Score (EASI) score greater than or equal to (\>=) 16 at screening and baseline visits
• Investigators Global Assessment (IGA) \>= 3 at screening and baseline visits
• Baseline pruritis numerical rating scale average score for maximum intensity of at least 3, based on the average of daily pruritis numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization
• Has applied a stable dose of topical moisturizer twice daily for at least 7 consecutive days immediately prior to the baseline visit and is willing to continue this regimen on a daily basis for the duration of the study
• \>= 10 percent (%) body surface area (BSA) of Atopic Dermatitis (AD) involvement at screening and baseline visits
• Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or participants for whom topical treatments are medically inadvisable (because of important side effects or safety risks): (a) Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0-2), despite treatment with a daily regimen of topical corticosteroids of medium to higher potency (with or without topical calcineurin inhibitors as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter; (b) Participants with documented systemic treatment for atopic dermatitis in the preceding 6 months are also considered to be inadequate responders to topical treatments and are potentially eligible for treatment with MABp1, after appropriate washout; (c) Important side effects or risks are those that outweigh the potential treatment benefits, and include: intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and adverse systemic effects; and (d) Acceptable documentation includes contemporaneous chart notes that record topical medication prescription and treatment outcome, or investigator documentation based on communication with the participant's treating physician.

You may not qualify if:

• Participants has been treated for AD with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to baseline
• Treatment with bermekimab at any time in the past
• Treatment with immunosuppressive/immunomodulatory drugs or phototherapy for atopic dermatitis within 4 weeks of baseline, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment
• Treatment with topical corticosteroids or topical calcineurin inhibitors for the treatment of AD within 14 days prior to baseline
• Treatment with biologics as follows: (a) Any cell-depleting agents including, but not limited to, rituximab, within 5 half-lives (if known) or 30 days prior to baseline visit, or until lymphocyte count returns to normal, whichever is longer; (b) Other biologics: within 5 half-lives (if known) or 30 days prior to baseline visit, whichever is longer
• Initiation of treatment of atopic dermatitis with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue to use stable doses of such moisturizers if initiated before the screening visit)
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit
• Planned or anticipated use of any prohibited medications and procedures during study treatment
• Treatment with a live (attenuated) vaccine within 30 days prior to the screening visit
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the baseline visit, or superficial skin infections within 1 week prior to the baseline visit
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (for example, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
• Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit
• At baseline, presence of any conditions listed as criteria for study drug discontinuation
• Presence of skin comorbidities that may interfere with study assessments

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (17)

Beach Clinical Research Inc

Huntington Beach, California, 92647, United States

Location

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134, United States

Location

Doral Medical Research

Doral, Florida, 33166, United States

Location

Floridian Research Institute

Miami, Florida, 33145, United States

Location

Florida International Medical Research

Miami, Florida, 33155, United States

Location

Premier Research Associate, Inc

Miami, Florida, 33165, United States

Location

CNS HealthCare

Orlando, Florida, 32801, United States

Location

Avita Clinical Research

Tampa, Florida, 33613, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Randall Dermatology & Cosmetic Surgery

West Lafayette, Indiana, 47906, United States

Location

Revival Research Institute LLC

Troy, Michigan, 48084, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Helios Clinical Research, LLC

Milan, Tennessee, 38358, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23233, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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

Limitations and Caveats

The relatively small sample size combined with the heterogeneity of the atopic dermatitis (AD) population were considered limitations of this study.

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: 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: July 12, 2019
• First Posted: July 16, 2019
• Study Start: October 16, 2019
• Primary Completion: June 30, 2020
• Study Completion: November 19, 2020
• Last Updated: February 4, 2025
• Results First Posted: September 5, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (17)