A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Overview
- Phase
- Phase 3
- Intervention
- Topical corticosteroid
- Conditions
- Atopic Dermatitis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 516
- Locations
- 156
- Primary Endpoint
- Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
- Status
- Active, Not Recruiting
- Last Updated
- 8 days ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At or above the 5th percentile of weight for age.
- •Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
- •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 beginning study treatment.
- •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 initiation of study drug 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 initiation of study drug.
- •Have high blood pressure characterized by a repeated systolic or diastolic blood pressure \>95th percentile based on age, sex and height.
Arms & Interventions
Baricitinib High Dose
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.
Intervention: Topical corticosteroid
Baricitinib Low Dose
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.
Intervention: Topical corticosteroid
Baricitinib Medium Dose
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.
Intervention: Topical corticosteroid
Placebo
Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.
Intervention: Topical corticosteroid
Baricitinib Open Label High Dose (PK Lead-in)
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.
Intervention: Topical corticosteroid
Placebo
Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.
Intervention: Placebo
Baricitinib Open Label High Dose (PK Lead-in)
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.
Intervention: Baricitinib
Baricitinib High Dose
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.
Intervention: Baricitinib
Baricitinib Medium Dose
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.
Intervention: Baricitinib
Baricitinib Low Dose
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.
Intervention: Baricitinib
Outcomes
Primary Outcomes
Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Time Frame: Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement
Time Frame: Week 16
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.
Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
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: Cmax,ss was derived by a population pharmacokinetics approach.
Secondary Outcomes
- Percentage of Participants Achieving IGA of 0(Week 16)
- Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry(Baseline, 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(Week 16)
- Percentage of Participants Achieving EASI50(Week 16)
- Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment(Week 16)
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)(Week 16)
- Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)(Week 16)
- Change From Baseline in SCORAD(Baseline, Week 16)
- Change From Baseline in Body Surface Area (BSA) Affected(Baseline, Week 16)
- Percentage of Participants Achieving EASI90(Week 16)
- Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)(Baseline Through 16 Weeks)
- Change From Baseline in EASI Score(Baseline, Week 16)
- Percentage of Participants Achieving SCORAD90(Week 16)
- Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score(Baseline, Week 16)
- Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry(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(Baseline, Week 16)
- Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104(Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose)
- Mean Gram Quantity of TCS Use (Tube Weights)(Baseline through 16 Weeks)
- Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry(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(Baseline, Week 16)
- Change of Immunoglobulin G (IgG) Titers(Baseline Through End of Study Completion)
- Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry(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(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(Baseline, Week 16)
- Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry(Baseline, Week 16)
- Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry(Week 2)
- Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104(Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose)
- Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score(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(Baseline, Week 16)
- Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry(Week 2)
- Height, Weight and Body Mass Index (BMI) Growth Rate(124 Weeks)