A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
ConditionDermatitis, Atopic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorPfizer
About this trial
The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD).
AD is a long-lasting itchy red rash, caused by a skin reaction.
This study is seeking participants who:
1. Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo 2. Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with moderate to severe AD who have been determined to start treatment with Cibinqo Tablet according to the approved indications of the medicinal product.
Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study
Disqualifiers
Patients who have previously received Cibinqo Tablet
Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products
Patients who have contraindications to Cibinqo Tablet as specified in the approved LPD • Contraindications to Cibinqo Tablet
Patients with platelet count <150 × 103/mm3, an absolute neutrophil count (ANC) <1 × 103/mm3, an absolute lymphocyte count (ALC) <0.5 × 103/mm3 or who have a haemoglobin value <8 g/dL
Trial population
The study population for this study is patients 12 years of age and older who have been diagnosed with moderate to severe Atopic Dermatitis (AD) and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Abrocitinib
DrugTablets
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of participants with Adverse Events (AE's) according to frequency
Time frame
Up to 52 weeks from the time of first treatment2
Number of participants with Adverse Drug Reactions (ADR's) according to frequency
Time frame
up to 52 weeks from the time of first treatment3
Number of participants with unexpected AE's according to frequency
Time frame
up to 52 weeks from the time of first treatment4
Number of participants with unexpected ADR's according to frequency
Time frame
up to 52 weeks from the time of first treatmentSecondary outcomes
1
Proportion of participants achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >=2 points
Time frame
At 12 weeks, and 52 weeks after the first treatment2
Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline
Time frame
At week 12 and 52 weeks after the first treatment3
Proportion of Participants Achieving >=4 Points improvement in the severity of Pruritus Numerical Rating Scale (NRS) from baseline
Time frame
At week 12 and 52 weeks after the first treatment Source ClinicalTrials.gov