Mode
Text Size
Log in / Sign up
Phase 3 Completed N=615 Randomized Double-blind Treatment

Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Source: ClinicalTrials.gov NCT03334422 ↗
Enrolled (actual)
615
Serious AEs
3.6%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib) — 4.5; 10.6; 13.8 percentage of participants — p=0.026
◆ Published Evidence
Established
43citations · ~9 / year
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials.
American journal of clinical dermatology · 2021 · Open access · Likely link

Summary

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

Linked Publications (5)

  • Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials.
    American journal of clinical dermatology · 2021 · 43 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
  • Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies.
    Dermatology and therapy · 2021 · 27 citations · Open access · Likely link
  • Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7.
    Dermatology and therapy · 2021 · 19 citations · Open access · Likely link
  • Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials.
    Dermatology and therapy · 2022 · 6 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)
4.5; 10.6; 13.8 0.026 sig
SECONDARY
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1mg Baricitinib)
4.5; 8.8 0.085
SECONDARY
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
6.1; 12.8; 17.9; 21.1 0.024 sig
SECONDARY
Percentage of Participants Achieving EASI90
2.5; 6.4; 8.9; 13.0 0.053
SECONDARY
Percent Change From Baseline on EASI Score
-28.91; -41.68; -54.80; -54.88 0.062
SECONDARY
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
1.6; 4.8; 7.3; 11.4 0.086
SECONDARY
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
4.7; 6.0; 15.1; 18.7 0.505
SECONDARY
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
-0.8; -1.10; -1.21; -1.38 0.074
SECONDARY
Change From Baseline in Skin Pain NRS
-0.86; -1.09; -2.61; -2.49 0.580
SECONDARY
Percentage of Participants Achieving EASI50
12.3; 18.4; 27.6; 29.3 0.094
SECONDARY
Percentage of Participants Achieving IGA of 0
1.6; 2.4; 4.1; 4.1 0.528
SECONDARY
Change From Baseline in SCORAD
-13.35; -20.23; -27.83; -27.50 0.059
SECONDARY
Percentage of Participants Achieving SCORAD90
1.2; 3.2; 4.1; 4.9 0.193
SECONDARY
Change From Baseline in Body Surface Area (BSA) Affected
12.82; -18.98; -22.12; -23.98 0.058
SECONDARY
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
7.8; 4.8; 7.3; 4.9 0.189
SECONDARY
Percent Change From Baseline in Itch NRS
-16.58; -31.39; 47.24; 46.87 0.081
SECONDARY
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
-1.48; -3.85; -7.06; -7.56 0.075
SECONDARY
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
-0.27; -0.53; -0.88; -0.96 0.130
SECONDARY
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)
-0.99; -1.93; -1.92; -2.30; -0.28; -0.78 0.067
SECONDARY
Change From Baseline on the Dermatology Life Quality Index (DLQI)
-3.35; -5.11; -7.44; -7.56 0.071
SECONDARY
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
-4.40; -5.31; -3.39; 0.76; -6.15; -9.27 0.861
SECONDARY
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
0.02; 0.05; 0.10; 0.10; 0.03; 0.06 0.295
SECONDARY
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
2.34; 2.75; 10.54; 11.16 0.907
SECONDARY
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
3.7; 3.2; 8.1; 15.4 0.905

Eligibility Criteria

Inclusion Criteria

  • Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
  • 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 prior to randomization.
  • Received prior treatment with any oral Janus kinase (JAK) inhibitor.
  • Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
  • Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
  • 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: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
  • Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
  • 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 (NCT03334422) 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