NCT05391061 A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
| NCT ID | NCT05391061 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Dermatitis, Atopic |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2023-01-07 |
| Primary Completion | 2027-11-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2023-01-07 with a primary completion date of 2027-11-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05391061 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Dermatitis, Atopic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05391061 currently recruiting?
Yes, NCT05391061 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05391061 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05391061 clinical trial?
NCT05391061 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 1,100 participants.