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Phase 2 Completed N=87 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT04021862 ↗
Enrolled (actual)
87
Serious AEs
0.6%
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16 — 13.8; 24.1; 34.5 percentage of participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16
13.8; 24.1; 34.5
SECONDARY
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
26.9; 8.0; 8.7; 34.6; 16.0; 26.1
SECONDARY
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
23.1; 13.6; 9.1; 30.8; 22.7; 27.3
SECONDARY
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
47.1; 23.5; 25.0; 41.2; 29.4; 30.0
SECONDARY
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
40.0; 33.3; 17.6; 33.3; 50.0; 35.3
SECONDARY
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32
10.3; 17.2; 10.3; 10.3; 13.8; 17.2
SECONDARY
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
0; 6.9; 6.9; 6.9; 17.2; 13.8
SECONDARY
Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32
6.9; 6.9; 10.3; 0; 10.3; 10.3
SECONDARY
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32
-4.86; -3.03; -3.41; -4.86; -3.29; -4.72
SECONDARY
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32
1.59; 2.00; 1.90; 1.45; 1.89; 2.62
SECONDARY
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32
0.86; 0.59; 1.31; 0.97; 0.57; 0.90
SECONDARY
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32
-4.79; -5.66; -6.59; -5.07; -6.14; -7.55
SECONDARY
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.
21.53; 21.29; 19.39; 24.27; 26.50; 22.45
SECONDARY
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.
2.97; 3.24; 2.07; 3.48; 3.54; 2.93

Eligibility 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 medica
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04021862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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