A Phase 3 interventional study of Baricitinib and Placebo in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 78 sites in 17 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 516 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have been treated with the following therapies:
Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.
Drug: Baricitinib · Drug: Topical corticosteroid
Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Drug: Baricitinib · Drug: Topical corticosteroid
Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Drug: Baricitinib · Drug: Topical corticosteroid
Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Drug: Baricitinib · Drug: Topical corticosteroid
Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.
Drug: Placebo · Drug: Topical corticosteroid
Administered orally
Also known as: LY3009104
Administered orally
Administered as standard-of-care
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement
Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time frame: Week 16
Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
Time frame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
Time frame: Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
Time frame: Week 16
Percentage of Participants Achieving EASI90
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.
Time frame: Week 16
Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Time frame: Week 16
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry
The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Time frame: Week 16
Percentage of Participants Achieving EASI50
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
Time frame: Week 16
Percentage of Participants Achieving IGA of 0
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time frame: Week 16
Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Percentage of Participants Achieving SCORAD90
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
Time frame: Week 16
Change From Baseline in Body Surface Area (BSA) Affected
Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Percentage of participants developing skin infections requiring antibiotic treatment
Time frame: Week 16
Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)
Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.
Time frame: Baseline Through 16 Weeks
Mean Gram Quantity of TCS Use (Tube Weights)
The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.
Time frame: Baseline through 16 Weeks
Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry
The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child's itching. Parent/Caregiver's report the overall severity of their child's itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants \<10 years old by the parent/caregiver. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score
The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity. LS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry
The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe". LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to \<8 years). Children aged \<5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.
Time frame: Baseline, Week 16
Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to \<8 years old). Children aged \<5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.
Time frame: Baseline, Week 16
Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry
CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry
Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Week 16
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score
The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity. LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry
The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to \<8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, Week 16
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry
The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Time frame: Week 2
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry
The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Time frame: Week 2
Height, Weight and Body Mass Index (BMI) Growth Rate
Height, Weight and BMI Growth Rate will be reported.
Time frame: 124 Weeks
Change of Immunoglobulin G (IgG) Titers
Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \>= 2-fold increase in \>=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with \>= 2-fold increase in participants with baseline titer \>=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.
Time frame: Baseline Through End of Study Completion
Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
Time frame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
Time frame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
| Milestone | Baricitinib Open Label High Dose (PK Lead-in) | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|---|
| Started | 33 | 0 | 0 | 0 | 0 |
| Received at least one dose of study drug | 33 | 0 | 0 | 0 | 0 |
| Completed | 33 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Baricitinib Open Label High Dose (PK Lead-in) | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|---|
| Started | 0 | 122 | 121 | 120 | 120 |
| Received at least one dose of study drug | 0 | 122 | 120 | 120 | 120 |
| Completed | 0 | 115 | 116 | 117 | 119 |
| Not completed | 0 | 7 | 5 | 3 | 1 |
| Withdrew: Adverse event | 0 | 2 | 1 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 4 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 | 2 | 0 |
| Withdrew: Inadvertently randomized | 0 | 0 | 1 | 0 | 0 |
Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement | 16.4 | 18.2 | 25.8 | 41.7 |
Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
| nanogram per milliliter (ng/mL) | Baricitinib Open Label High Dose 2 to <6 | Baricitinib Open Label High Dose 6 to <10 | Baricitinib Open Label High Dose 10 to <18 |
|---|---|---|---|
| Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104 | 63.2 ± 30 | 40.1 ± 32 | 50.6 ± 29 |
Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
| hour*nanogram per milliliter (h*ng/mL) | Baricitinib Open Label High Dose 2 to <6 | Baricitinib Open Label High Dose 6 to <10 | Baricitinib Open Label High Dose 10 to <18 |
|---|---|---|---|
| Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104 | 251 ± 18 | 178 ± 18 | 290 ± 44 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) | 32 | 32.2 | 40 | 52.5 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI90 | 12.3 | 11.6 | 21.7 | 30.0 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in EASI Score | -14.16 ± 1.001 | -15.67 ± 0.990 | -15.83 ± 0.978 | -16.88 ± 0.984 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) | 9.8 | 7.4 | 15.8 | 20.0 |
The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry | 16.4 | 17.5 | 25.8 | 35.5 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI50 | 55.7 | 59.5 | 60.8 | 71.7 |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving IGA of 0 | 4.1 | 5.0 | 5.0 | 12.5 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in SCORAD | -20.93 ± 1.894 | -24.82 ± 1.880 | -26.08 ± 1.857 | -28.55 ± 1.867 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Achieving SCORAD90 | 3.3 | 1.7 | 5.0 | 12.5 |
Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| percentage of body surface area | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in Body Surface Area (BSA) Affected | -20.31 ± 1.622 | -21.83 ± 1.608 | -22.06 ± 1.581 | -25.66 ± 1.593 |
Percentage of participants developing skin infections requiring antibiotic treatment
| Percentage of participants | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | 5.7 | 5.0 | 3.3 | 2.5 |
Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.
| days | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Mean Number of Days Without Use of Background Topical Corticosteroid (TCS) | 27.74 ± 4.06 | 32.22 ± 4.07 | 30.86 ± 4.06 | 39.91 ± 4.10 |
The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.
| grams | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Mean Gram Quantity of TCS Use (Tube Weights) | 265.79 ± 22.04 | 216.60 ± 22.09 | 228.41 ± 22.05 | 185.42 ± 22.26 |
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry | -1.15 ± 0.276 | -1.80 ± 0.266 | -1.65 ± 0.261 | -2.25 ± 0.258 |
The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child's itching. Parent/Caregiver's report the overall severity of their child's itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants \<10 years old by the parent/caregiver. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry | -0.02 ± 0.139 | -0.24 ± 0.146 | -0.49 ± 0.145 | -0.37 ± 0.158 |
The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity. LS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score | -3.02 ± 0.708 | -3.93 ± 0.704 | -4.58 ± 0.696 | -4.58 ± 0.702 |
The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe". LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry | -0.33 ± 0.115 | -0.56 ± 0.112 | -0.64 ± 0.109 | -0.83 ± 0.108 |
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to \<8 years). Children aged \<5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.
| T-score | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| 5 to <8 years old | -3.95 ± 2.629 | -2.54 ± 2.138 | -7.07 ± 2.644 | -2.83 ± 2.033 |
| 8 to <18 years old | -3.60 ± 1.190 | -3.42 ± 1.343 | -4.68 ± 1.034 | -5.30 ± 1.436 |
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to \<8 years old). Children aged \<5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.
| T-score | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| 5 to <8 years old | -4.65 ± 2.864 | -3.03 ± 2.318 | -5.09 ± 2.931 | -3.15 ± 2.214 |
| 8 to <18 years old | -4.40 ± 1.223 | -4.09 ± 1.394 | -5.44 ± 1.064 | -6.81 ± 1.486 |
CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| Score on a Scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry | -3.06 ± 0.480 | -3.73 ± 0.465 | -3.70 ± 0.451 | -3.36 ± 0.459 |
Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry | -1.40 ± 1.743 | 3.87 ± 4.423 | 3.33 ± 3.752 | -6.40 ± 3.601 |
The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity. LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| score on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Absenteeism | 3.99 ± 2.367 | 2.39 ± 2.135 | 2.14 ± 2.107 | -0.94 ± 2.387 |
| Presenteeism | -4.69 ± 2.719 | -5.62 ± 2.452 | -9.99 ± 2.451 | -11.44 ± 2.797 |
| Overall Work Impairment | 0.38 ± 3.473 | -3.80 ± 3.119 | -5.86 ± 3.086 | -11.15 ± 3.515 |
| Activity Impairment | -7.03 ± 2.372 | -11.45 ± 2.318 | -11.90 ± 2.293 | -14.05 ± 2.311 |
The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to \<8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| score on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry | 3.15 ± 2.090 | 5.12 ± 2.025 | 5.16 ± 1.969 | 7.67 ± 2.000 |
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
| score on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry | -0.42 ± 0.130 | -0.35 ± 0.126 | -0.43 ± 0.123 | -0.55 ± 0.122 |
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| score on a scale | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose |
|---|---|---|---|---|
| Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry | -1.15 ± 0.267 | -1.23 ± 0.259 | -1.56 ± 0.254 | -1.77 ± 0.251 |
The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
| Participant responses | Baricitinib Open Label High Dose |
|---|---|
| Question 1- Liked Very Much: | 8 |
| Question 1- Liked | 1 |
| Question 1- Neither Liked nor Disliked | 3 |
| Question 1- Disliked | 1 |
| Question 1- Disliked Very Much | 0 |
| Question 2- Liked Very Much: | 6 |
| Question 2- Liked | 1 |
| Question 2- Neither Liked nor Disliked | 6 |
| Question 2- Disliked | 0 |
| Question 2- Disliked Very Much | 0 |
| Question 3- Very Easy | 8 |
| Question 3- Easy | 5 |
| Question 3- Neither Easy nor Hard | 0 |
| Question 3- Difficult (or Hard) | 0 |
| Question 3- Very Difficult (or Hard) | 0 |
| Question 4- Very Easy | 9 |
| Question 4- Easy | 4 |
| Question 4- Neither Easy nor Hard | 0 |
| Question 4- Difficult (or Hard) | 0 |
| Question 4- Very Difficult (or Hard) | 0 |
The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
| Participant responses | Baricitinib Open Label High Dose |
|---|---|
| Question 1- Very Easy | 18 |
| Question 1- Easy | 0 |
| Question 1- Neither Easy nor Hard | 0 |
| Question 1- Difficult (or Hard) | 0 |
| Question 1- Very Difficult (or Hard) | 0 |
Height, Weight and BMI Growth Rate will be reported.
Results for this outcome have not been posted.
Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \>= 2-fold increase in \>=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with \>= 2-fold increase in participants with baseline titer \>=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.
Results for this outcome have not been posted.
Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
| nanograms per milliliter (ng/mL) | Baricitinib (0.5 mg): Low Dose (2 to<6 Years) | Baricitinib (1 mg): Medium Dose (2 to<6 Years) | Baricitinib (2 mg): High Dose (2 to<6 Years) | Baricitinib (0.5mg): Low Dose (6 to <10 Years) | Baricitinib (1 mg): Medium Dose (6 to <10 Years) | Baricitinib (2 mg): High Dose (6 to <10 Years) | Baricitinib (1 mg): Low Dose (10 to <18 Years) | Baricitinib (2 mg): Medium Dose (10 to <18 Years) | Baricitinib (4 mg): High Dose (10 to <18 Years) |
|---|---|---|---|---|---|---|---|---|---|
| Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104 | 18.9 ± 29 | 35.1 ± 21 | 64.8 ± 22 | 11.6 ± 29 | 23.1 ± 23 | 44.0 ± 41 | 13.2 ± 34 | 27.8 ± 34 | 50.7 ± 28 |
Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
| hour*nanogram per milliliter (h*ng/ mL) | Baricitinib (0.5mg): Low Dose (2 to<6 Years) | Baricitinib (1 mg): Medium Dose (2 to<6 Years) | Baricitinib (2 mg): High Dose (2 to<6 Years) | Baricitinib (0.5mg): Low Dose (6 to <10 Years) | Baricitinib (1 mg): Medium Dose (6 to <10 Years) | Baricitinib (2 mg): High Dose (6 to <10 Years) | Baricitinib (1 mg): Low Dose (10 to <18 Years) | Baricitinib (2 mg): Medium Dose (10 to <18 Years) | Baricitinib (4 mg): High Dose (10 to <18years) |
|---|---|---|---|---|---|---|---|---|---|
| Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104 | 94.3 ± 108 | 200 ± 63 | 298 ± 51 | 74.8 ± 64 | 155 ± 65 | 276 ± 76 | 109 ± 63 | 222 ± 66 | 383 ± 61 |
Collected over Baseline Up to 16 Weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Double-blind | 0/122 (0%) | 5/122 (4.1%) | 42/122 (34.4%) |
| Baricitinib Double-blind Low Dose | 0/120 (0%) | 2/120 (1.7%) | 39/120 (32.5%) |
| Baricitinib Double-blind Mid Dose | 0/120 (0%) | 1/120 (0.8%) | 44/120 (36.7%) |
| Baricitinib Double-blind High Dose | 0/120 (0%) | 1/120 (0.8%) | 41/120 (34.2%) |
| Baricitinib Open-label High Dose PK Lead-in | 0/33 (0%) | 0/33 (0%) | 11/33 (33.3%) |
| Event | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Mid Dose | Baricitinib Double-blind High Dose | Baricitinib Open-label High Dose PK Lead-in |
|---|---|---|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 3/122 | 1/120 | 0/120 | 0/120 | 0/33 |
| Corneal abscessInfections and infestations | 0/122 | 0/120 | 0/120 | 1/120 | 0/33 |
| Ophthalmic herpes simplexInfections and infestations | 0/122 | 0/120 | 0/120 | 1/120 | 0/33 |
| Vertigo cns originNervous system disorders | 0/122 | 0/120 | 1/120 | 0/120 | 0/33 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/122 | 1/120 | 0/120 | 0/120 | 0/33 |
| Covid-19Infections and infestations | 1/122 | 0/120 | 0/120 | 0/120 | 0/33 |
| ImpetigoInfections and infestations | 1/122 | 0/120 | 0/120 | 0/120 | 0/33 |
| Suicide attemptPsychiatric disorders | 1/122 | 0/120 | 0/120 | 0/120 | 0/33 |
| Event | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Mid Dose | Baricitinib Double-blind High Dose | Baricitinib Open-label High Dose PK Lead-in |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 10/122 | 7/120 | 11/120 | 6/120 | 1/33 |
| NasopharyngitisInfections and infestations | 6/122 | 4/120 | 5/120 | 5/120 | 2/33 |
| Abdominal painGastrointestinal disorders | 3/122 | 3/120 | 5/120 | 6/120 | 0/33 |
| BronchitisInfections and infestations | 1/122 | 6/120 | 1/120 | 3/120 | 0/33 |
| AcneSkin and subcutaneous tissue disorders | 5/122 | 3/120 | 4/120 | 6/120 | 0/33 |
| Urinary tract infectionInfections and infestations | 6/122 | 2/120 | 0/120 | 0/120 | 0/33 |
| DiarrhoeaGastrointestinal disorders | 2/122 | 1/120 | 2/120 | 5/120 | 1/33 |
| Covid-19Infections and infestations | 3/122 | 5/120 | 5/120 | 3/120 | 0/33 |
| Upper respiratory tract infectionInfections and infestations | 1/122 | 3/120 | 4/120 | 5/120 | 0/33 |
| Abdominal pain upperGastrointestinal disorders | 1/122 | 2/120 | 2/120 | 4/120 | 1/33 |
All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1). All randomized participants in the double-blind treatment period (Study period 2).
| Age, Continuous(years) | Baricitinib Open Label High Dose | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose | Total |
|---|---|---|---|---|---|---|
| Mean | 11.28 ± 4.296 | 11.75 ± 4.012 | 12.35 ± 4.052 | 11.81 ± 3.661 | 11.93 ± 3.829 | 11.92 ± 3.914 |
| Age, Customized(Participants) | Baricitinib Open Label High Dose | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose | Total |
|---|---|---|---|---|---|---|
| 2 to <6 years | 6 | 14 | 9 | 8 | 9 | 46 |
| 6 to <10 years | 7 | 20 | 24 | 26 | 23 | 100 |
| 10 to <18 years | 20 | 88 | 88 | 86 | 88 | 370 |
| Sex: Female, Male(Participants) | Baricitinib Open Label High Dose | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose | Total |
|---|---|---|---|---|---|---|
| Female | 20 | 64 | 62 | 63 | 53 | 262 |
| Male | 13 | 58 | 59 | 57 | 67 | 254 |
| Race (NIH/OMB)(Participants) | Baricitinib Open Label High Dose | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 3 | 1 | 3 | 9 |
| Asian | 19 | 16 | 18 | 18 | 21 | 92 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 2 | 5 | 4 | 14 |
| White | 13 | 94 | 94 | 93 | 88 | 382 |
| More than one race | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 8 | 4 | 2 | 4 | 18 |
| Region of Enrollment(Participants) | Baricitinib Open Label High Dose | Placebo Double-blind | Baricitinib Double-blind Low Dose | Baricitinib Double-blind Medium Dose | Baricitinib Double-blind High Dose | Total |
|---|---|---|---|---|---|---|
| Argentina | 0 | 16 | 18 | 18 | 18 | 70 |
| Hungary | 0 | 4 | 5 | 2 | 2 | 13 |
| Czechia | 0 | 6 | 7 | 4 | 5 | 22 |
| Japan | 0 | 9 | 10 | 10 | 9 | 38 |
| United Kingdom | 3 | 2 | 1 | 3 | 0 | 9 |
| India | 0 | 1 | 1 | 2 | 1 | 5 |
| Russia | 0 | 12 | 13 | 11 | 9 | 45 |
| Spain | 10 | 7 | 6 | 6 | 7 | 36 |
| Austria | 0 | 1 | 3 | 1 | 2 | 7 |
| Taiwan | 18 | 5 | 4 | 3 | 11 | 41 |
| Brazil | 0 | 7 | 9 | 7 | 11 | 34 |
| Poland | 0 | 19 | 19 | 25 | 26 | 89 |
| Mexico | 0 | 13 | 7 | 7 | 7 | 34 |
| Israel | 2 | 8 | 11 | 10 | 8 | 39 |
| Australia | 0 | 3 | 1 | 6 | 0 | 10 |
| France | 0 | 8 | 4 | 2 | 4 | 18 |
| Germany | 0 | 1 | 2 | 3 | 0 | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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