B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country. The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,166
In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
University of Alabama at Birmingham - Dermatology Research Clinic
Birmingham, Alabama, United States
University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, United States
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Treatment emergent adverse events
The incidence of treatment emergent adverse events
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serious adverse events and adverse events leading to discontinuation
The incidence of serious adverse events and adverse events leading to discontinuation
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in clinical laboratory values
Change from baseline in clinical laboratory values
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in electrocardiogram (ECG) measurements
Change from baseline in electrocardiogram (ECG) measurements
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in vital signs
Change from baseline in vital signs
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Investigator's Global Assessment (IGA)
Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of \>=2 points at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Eczema Area and Severity Index (EASI)
Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Pruritus Numerical Rating Scale (NRS)
Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Global Assessment (PtGA)
Change from baseline of PtGA at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Body Surface Area (BSA) affected
Change from baseline in the percentage BSA affected at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
Change from baseline in DLQI or CDLQI at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Oriented Eczema Measure (POEM)
Change from baseline in POEM at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in HADS at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)
Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
Time frame: Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Steroid-Free Days
Number of steroid-free days will be assessed throughout the duration of the study.
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serum Hs-CRP Levels
Serum Hs-CRP levels at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change in height standard deviation score (SDS)
Change in height standard deviation score (SDS) at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Time frame: Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 years
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The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States
Emmaus Research Center, Inc.
Anaheim, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Marvel Research, LLC
Huntington Beach, California, United States
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