Mode
Text Size
Log in / Sign up
Phase 3 Completed N=440 Randomized Double-blind Treatment

A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis

Source: ClinicalTrials.gov NCT03435081 ↗
Enrolled (actual)
440
Serious AEs
1.2%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) — 8.2; 29.5 percentage of participants — p=<0.001
◆ Published Evidence
Established
56citations · ~14 / year
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.
The British journal of dermatology · 2022 · Open access · Likely link

Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.

Linked Publications (5)

  • The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.
    The British journal of dermatology · 2022 · 56 citations · Open access · Likely link
  • Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis.
    Health and quality of life outcomes · 2021 · 35 citations · Open access · Likely link
  • Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16.
    Dermatology and therapy · 2022 · 9 citations · Open access · Likely link
  • Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials.
    Dermatitis : contact, atopic, occupational, drug · 2023 · 6 citations · Open access · Likely link
  • Onset of Symptom Relief Reported in Daily Diaries of Patients With Atopic Dermatitis Treated With Baricitinib in a United States Clinical Trial (BREEZE-AD5).
    Journal of cutaneous medicine and surgery · 2022 · 6 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
8.2; 29.5 <0.001 sig
SECONDARY
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
2.7; 5.4; 8.2 0.258
SECONDARY
Percentage of Participants Achieving EASI75 (1 mg Baricitinib)
8.2; 12.9 0.167
SECONDARY
Percentage of Participants Achieving EASI90
3.4; 7.5; 20.5 0.131
SECONDARY
Percent Change From Baseline in EASI Score
-34.07; -46.66; -54.37 0.077
SECONDARY
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
2.7; 3.4; 14.4 0.733
SECONDARY
Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS)
5.7; 15.9; 25.2 0.012 sig
SECONDARY
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
-0.40; -0.62; -0.99 0.433
SECONDARY
Change From Baseline in Skin Pain NRS
-1.03; -2.16; -2.40 0.012 sig
SECONDARY
Percentage of of Participants Achieving EASI50
12.9; 19.7; 34.9 0.105
SECONDARY
Percentage of Participants Achieving IGA of 0
0.7; 3.4; 2.7 0.144
SECONDARY
Change From Baseline in SCORAD
-14.37; -18.31; -26.18 0.316
SECONDARY
Percentage of Participants Achieving SCORAD90
1.4; 2.0; 3.4 0.683
SECONDARY
Change From Baseline in Body Surface Area (BSA) Affected
-9.67; -15.69; -17.39 0.046 sig
SECONDARY
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
5.5; 4.1; 4.1 0.598
SECONDARY
Percent Change From Baseline in Itch NRS
-18.01; -30.28; -39.87 0.063
SECONDARY
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
-2.67; -4.57; -7.44 0.217
SECONDARY
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
-0.46; -0.71; -0.88 0.155
SECONDARY
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
-2.03; -1.50; -2.55; -1.31; -0.87; -1.73 0.345
SECONDARY
Change From Baseline on the Dermatology Life Quality Index (DLQI)
-3.97; -5.47; -7.46 0.224
SECONDARY
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
3.41; 0.05; 2.34; -3.44; -15.18; -19.33 0.575
SECONDARY
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm
0.04; 0.06; 0.10; 0.07; 0.09; 0.14 0.482
SECONDARY
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
4.67; 3.34; 8.14 0.609
SECONDARY
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
2.7; 5.4; 8.2 0.258

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.
  • Have moderate to severe AD, including all of the following:
  • EASI score ≥16
  • IGA score of ≥3
  • ≥10% of BSA involvement
  • Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
  • Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
  • Agree to use emollients daily.

Exclusion Criteria

  • Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
  • A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
  • Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
  • Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
  • Have been treated with the following therapies:
  • monoclonal antibody for less than 5 half-lives before randomization
  • received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization
  • received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
  • have had an intra-articular corticosteroid injection within 6 weeks of planned randomization
  • probenecid at the time of randomization that cannot be discontinued for the duration of the study
  • Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
  • Have had major surgery within the past eight weeks or are planning major surgery during the study.
  • Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
  • Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE.
  • Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
  • Have specific laboratory abnormalities.
  • Have received certain treatments that are contraindicated.
  • Pregnant or breastfeeding.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03435081) and the linked publication. 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.

Back to search