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Trial record 2 of 3 for:    bermekimab | Atopic Dermatitis

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

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ClinicalTrials.gov Identifier: NCT04021862
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Bermekimab Monoclonal Antibody Drug: Placebo Phase 2

Detailed Description:

This is a phase II, randomized, double-blind, placebo-controlled study of bermekimab in patients with moderate to severe atopic dermatitis. The primary objective of the study is to analyze the safety and efficacy of different dose regimens of bermekimab compared to placebo treatment in adult patients with moderate-to-severe AD. The study is multicenter and will consist of three groups:

Treatment Arm 1: Bermekimab every week (qw)

Treatment Arm 2: Bermekimab every other week (q2w)

Arm 3 (Placebo): Placebo every week (qw)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : October 16, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : November 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Treatment Arm 1 (bermekimab every week)

Loading Dose: 400 mg subcutaneous (SC) injection of bermekimab and a SC injection of placebo at week 0 (Baseline)

Treatment Dose: 400 mg subcutaneous injection of bermekimab administered weekly (qw) from week 1 to week 15.

Drug: Bermekimab Monoclonal Antibody
Bermekimab 2 mL (200 mg/mL) pre-filled syringe

Drug: Placebo
Placebo 2 mL pre-filled syringe

Experimental: Treatment Arm 2 (bermekimab every other week)

Loading Dose: Two 400 mg SC injections of bermekimab at week 0 (Baseline)

Treatment Dose: 400 mg SC injection of bermekimab administered every other week (q2w) alternating with placebo q2w from week 1 to week 15

Drug: Bermekimab Monoclonal Antibody
Bermekimab 2 mL (200 mg/mL) pre-filled syringe

Drug: Placebo
Placebo 2 mL pre-filled syringe

Placebo Comparator: Placebo

Loading Dose: Two SC injections of placebo at week 0 (Baseline)

Treatment Dose: Subcutaneous injection of placebo administered once weekly (qw) from week 1 to week 15.

Drug: Placebo
Placebo 2 mL pre-filled syringe




Primary Outcome Measures :
  1. Proportion of patients with EASI-75 (≥75% improvement in Eczema Area and Severity Index Score [EASI]) from baseline at week 16. [ Time Frame: Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics will be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, arms, and legs and converted to a score of 0 to 6. The EASI assessment tool is provided in the Study Reference Manual.

  2. Overall incidence of treatment emergent adverse events (TEAEs) from baseline to week 16 [ Time Frame: Baseline through Week 16 ]
    TEAEs are defined as AEs that occurred during the treatment period and were not present during the baseline visit or were present at baseline but worsened in severity during the treatment period.


Secondary Outcome Measures :
  1. Proportion of patients with ≥4-point improvement (reduction) in the weekly average peak daily Pruritus Numeric Rating Scale (NRS) score from baseline at week 16 in patients with baseline score ≥4. [ Time Frame: Week 16 ]

    The Pruritus NRS is a simple assessment tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period using a study diary. Patients will be asked to complete the following question:

    • For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?"


  2. Proportion of patients with ≥4-point improvement (reduction) in the weekly average overall Pruritus Numeric Rating (NRS) from baseline at week 16 in patients with baseline score ≥4. [ Time Frame: Week 16 ]

    The Pruritus NRS is a simple assessment tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period using a study diary. Patients will be asked to complete the following questions:

    • For average itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch overall (on average) during the previous 24 hours?"


  3. Proportion of patients with ≥4-point improvement (reduction) in the weekly average Numerical Pain Rating Scale (NPRS) score from baseline at week 16 [ Time Frame: Week 16 ]
    The Numeric Pain Rating Scale (NPRS) is a unidimensional 11-point measure of pain intensity in adults. Patients will be given a diary to complete each night before bed, in which they will select a number from 0-10 (0 = no pain , and 10 = worst imaginable pain") that best reflects the intensity of his/her pain. Patient diaries will be collected and responses will be assessed weekly until study completion.

  4. Proportion of patients with a Investigators Global Assessment (IGA) score of 0 or 1 and a reduction in this measure of at least 2 points at week 16. [ Time Frame: Week 16 ]
    The IGA is an assessment scale used in clinical studies to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA is provided in the study reference manual.

  5. Proportion of patients with EASI-90 (≥90% improvement in Eczema Area and Severity Index Score [EASI] from baseline) at week 16 [ Time Frame: Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics will be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, arms, and legs and converted to a score of 0 to 6. The EASI assessment tool is provided in the Study Reference Manual.

  6. Change in Dermatology Life Quality Index (DLQI) from baseline to week 16. [ Time Frame: Baseline and Week 16 ]
    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL. The DLQI is provided in the study reference manual.

  7. Change in Hospital Anxiety Depression Scale (HADS) (Anxiety) from baseline to weeks 16 [ Time Frame: Baseline and Week 16 ]
    The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consists of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. The HADS is provided in the study reference manual.

  8. Change in Hospital Anxiety Depression Scale (HADS) (Depression) from baseline to week 16. [ Time Frame: Baseline and Week 16 ]
    The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consists of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. The HADS is provided in the study reference manual.

  9. Change in Patient Oriented Eczema Measure (POEM) Scores from baseline to week 16. [ Time Frame: Baseline and Week 16 ]
    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on frequency during the past week (ie, 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days) with a scoring system of 0 to 28; the total score reflects disease-related morbidity. The POEM is provided in the study reference manual.

  10. Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 16. [ Time Frame: Baseline and Week 16 ]
    SCORAD was developed by the European Task Force on Atopic Dermatitis. (Severity scoring of Atopic Dermatitis: the SCORAD index), as a measure of disease severity in AD. It includes assessment of the eczema in addition to patient-reported symptoms. Total score ranges from 0 to 103 (no disease to most severe disease, respectively).

  11. Change in Global Individual Signs Score (GISS) from baseline to week 16 [ Time Frame: Baseline and Week 16 ]
    GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component will be rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. Total score will range from 0 to 12 (no disease to most severe disease, respectively).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin diagnosed active endoparasitic infections; suspected or high risk of endoparasitic, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the Participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, participants with uncontrolled diabetes (HbA1c >= 9%), participants with cardiovascular conditions (for example, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (for example, participants on dialysis), hepato-biliary conditions (for example, Child-Pugh class B or C), neurological conditions (for example, demyelinating diseases), active major autoimmune diseases (for example, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in study documents (chart notes, case report forms [CRFs], etc.)
  • Planned or anticipated major surgical procedure during the participant's participation in this study
  • Membership of the investigational team or his/her immediate family
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
  • Women unwilling to use adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception throughout the duration of the study and for 120 days after the last dose of study drug. These methods include hormonal contraceptives, intrauterine device, double barrier contraception (that is, condom + diaphragm), or male partner with a documented vasectomy
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies
  • Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant as a result of his/her participation in the study, may make participant's participation unreliable, or may interfere with study assessments. The specific justification for participant excluded under this criterion will be noted in study documents (chart notes, case report forms, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021862


Locations
Show Show 17 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04021862    
Other Study ID Numbers: CR108833
77474462ADM2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs