Clinical trial NCT05391061: A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
Official title: Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis, Abrocitinib, Cibinqo
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 1100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.

The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.

The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.

About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.

Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.

There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).

Eligibility criteria: This study is seeking participants who should meet the usual prescribing criteria for Cibinqo® Tablets as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Inclusion Criteria:

1. 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.

   • Atopic Dermatitis Cibinqo Tablet is indicated for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis who have required systemic therapies.
2. 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

Exclusion Criteria:

1. Patients who have previously received Cibinqo Tablet
2. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products
3. 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
   * Hypersensitivity to the active substance or to any of the excipients
   * Active serious systemic infetions, including tuberculosis(TB)
   * Severe hepatic impairment
   * Pregnancy and breast-feeding
   * Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Primary outcomes:
measure: Number of participants with Adverse Events (AE's) according to frequency
timeFrame: Up to 52 weeks from the time of first treatment
measure: Number of participants with Adverse Drug Reactions (ADR's) according to frequency
timeFrame: up to 52 weeks from the time of first treatment
measure: Number of participants with unexpected AE's according to frequency
timeFrame: up to 52 weeks from the time of first treatment
measure: Number of participants with unexpected ADR's according to frequency
timeFrame: up to 52 weeks from the time of first treatment
measure: Number of participants with Serious Adverse Events (SAE's) according to frequency
timeFrame: up to 52 weeks from the time of first treatment
measure: Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency
timeFrame: up to 52 weeks from the time of first treatment
measure: Number of participants with Adverse Events of Special Interest (AESI) according to frequency
timeFrame: up to 52 weeks from the time of first treatment
Secondary outcomes:
measure: 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
timeFrame: At 12 weeks, and 52 weeks after the first treatment
measure: Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline
timeFrame: At week 12 and 52 weeks after the first treatment
measure: Proportion of Participants Achieving >=4 Points improvement in the severity of Pruritus Numerical Rating Scale (NRS) from baseline
timeFrame: At week 12 and 52 weeks after the first treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Tower
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: