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Phase 3 Completed N=463 Randomized Double-blind Treatment

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable

Source: ClinicalTrials.gov NCT03428100 ↗
Enrolled (actual)
463
Serious AEs
9.1%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib) — 17.2; 27.6; 31.5 percentage of participants — p=0.071
◆ 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 determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.

Linked Publications (2)

  • 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
  • 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 Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)
17.2; 27.6; 31.5 0.071
SECONDARY
Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib)
17.2; 22.6 0.427
SECONDARY
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement
9.7; 12.9; 15.1; 21.7 0.513
SECONDARY
Percentage of Participants Achieving EASI90
6.5; 8.6; 10.3; 14.1 0.611
SECONDARY
Percent Change From Baseline in EASI Score
-42.69; -60.34; -56.05; -63.31 0.002 sig
SECONDARY
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
1.1; 6.5; 8.1; 6.5 0.115
SECONDARY
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
8.2; 23.1; 22.9; 38.2 0.012 sig
SECONDARY
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
-0.63; -1.05; -0.85; -1.42 0.039 sig
SECONDARY
Change From Baseline in Skin Pain NRS
-1.56; -2.27; -2.40; -3.02 0.0714
SECONDARY
Percentage of Participants Achieving IGA of 0 or 1 With a >=2-point Improvement
12.9; 20.4; 18.9; 13.0 0.183
SECONDARY
Percentage of Participants Achieving EASI50
35.5; 45.2; 51.4; 52.2 0.263
SECONDARY
Percentage of Participants Achieving EASI75
26.9; 33.3; 30.3; 37.0 0.382
SECONDARY
Percentage of Participants Achieving IGA of 0
0.00; 2.2; 1.1; 3.3 0.265
SECONDARY
Change From Baseline in SCORAD
-21.98; -28.06; -28.54; -31.74 0.040 sig
SECONDARY
Percentage of Participants Achieving SCORAD90
0.00; 2.2; 1.1; 2.2 0.265
SECONDARY
Change From Baseline in Body Surface Area (BSA) Affected
-19.76; -25.98; -25.26; -28.17 0.044 sig
SECONDARY
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
5.4; 6.5; 6.5; 5.4 >.999
SECONDARY
Mean Number of Days Without Topical Corticosteroids (TCS) Use
12.18; 20.80; 17.65; 19.43 0.056
SECONDARY
Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
242.59; 194.53; 185.70; 171.17 0.178
SECONDARY
Percent Change From Baseline in Itch NRS
-17.48; -28.80; -32.89; -37.24 0.088
SECONDARY
Percent Change From Baseline in Itch NRS at Week 24
-15.35; -29.35; -30.11; -33.16 0.055
SECONDARY
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
-4.18; -6.24; -7.27; -9.27 0.095
SECONDARY
Change From Baseline in the Patient Global Impression of Severity - Atopic Dermatitis (PGI-S-AD) Score
-0.49; -0.74; -0.77; -1.07 0.097
SECONDARY
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
-0.48; -1.04; -1.59; -1.32; -0.40; -0.69 0.272
SECONDARY
Change From Baseline in the Dermatology Life Quality Index (DLQI)
-4.95; -6.18; -6.57; -7.95 0.228
SECONDARY
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
-4.77; -5.69; -2.98; -4.56; -14.86; -11.80 0.784
SECONDARY
Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
0.04; 0.08; 0.09; 0.11; 0.06; 0.11 0.131
SECONDARY
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
7.64; 11.63; 8.76; 11.03 0.221
SECONDARY
Percentage of Participants Achieving EASI75
26.9; 33.3; 30.3; 37.0 0.382
SECONDARY
Percent Change From Baseline in Itch NRS at Week 52
-12.13; -19.49; -16.01; -29.31 0.447
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
93.8; 56.3; 84.0; 50.0
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
68.8; 50.0; 72.0; 25.0
SECONDARY
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
50; 25.0; 44.0; 20.8
SECONDARY
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
43.8; 25.0; 44.0; 8.3
SECONDARY
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
75.0; 56.3; 72.0; 41.7
SECONDARY
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
68.8; 56.3; 56.0; 33.3
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
100; 77.8; 100; 55.6
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
80.0; 66.7; 100; 33.3
SECONDARY
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
60.0; 33.3; 90.0; 55.6
SECONDARY
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
50.0; 33.3; 90.0; 22.2
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 68 Participants Not Entered Into Substudy (All Participants)
100; 86.4; 100; 93.1
SECONDARY
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 Participants Not Entered Into Substudy (All Participants)
100; 86.4; 97.1; 93.1
SECONDARY
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
14.3; 50.0; 47.1; 51.7
SECONDARY
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
42.9; 50.0; 47.1; 48.3
SECONDARY
Percentage of Participants With A Response of EASI75 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
57.1; 63.6; 76.5; 62.1
SECONDARY
Percentage of Participants With A Response of EASI75 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
85.7; 68.2; 70.6; 72.4
SECONDARY
Time to Retreatment (Time to IGA ≥3) Randomized Downtitration (All Patients Entering the Substudy)
218; 79; 68; 71

Eligibility Criteria

Inclusion Criteria

  • Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months.
  • Have had inadequate response 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.
  • Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past.

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 episodes of eczema herpeticum in the past.
  • Participants who are currently experiencing a skin infection that requires treatment, or are 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 less than 4 weeks prior to randomization.
  • Received oral corticosteroids within 4 weeks prior to randomization or 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, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
  • Have a current or recent and/or clinically serious viral, bacterial, fungal, or parasitic infection including but not limited to herpes zoster, tuberculosis.
  • Have specific laboratory abnormalities related to thyroid, renal and liver function, or blood cells.
  • Have received certain treatments that are contraindicated.
  • Pregnant or breastfeeding.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03428100) 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.

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