Observing the effects of Cibinqo in patients with atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and effectiveness of Cibinqo (Abrocitinib) in patients aged 12 and older with moderate to severe atopic dermatitis (AD) in Korea. Participants will be enrolled as they begin treatment with Cibinqo, and their experiences will be monitored over approximately one year. The study will collect data on the participants' responses to the medication in a real-world clinical setting, without a fixed visit schedule. The goal is to gather insights that will inform the ongoing use of Cibinqo for treating AD.

Why it matters

Who can join: the full rules

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

Where it's running

• Pfizer Tower
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AR100DP1 cream for mild to moderate atopic dermatitis

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• 611 in Chinese children with moderate to severe atopic dermatitis

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  This study will test whether DCY636 is safe and tolerated in healthy adults and whether it can be safely given to people with moderate to severe atopic dermatitis.

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• Camoteskimab in adults with moderate-to-severe atopic dermatitis

  This trial tests different doses of camoteskimab versus placebo to see if it helps adults with moderate-to-severe atopic dermatitis who have not fully responded to standard treatments.

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• Testing 611 for moderate to severe atopic dermatitis in Chinese adolescents

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  Recruiting at 3 sites Phase 3 Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Beijing, Beijing Municipality and 2 other locations · NCT07042126

• Abrocitinib for moderate-to-severe atopic dermatitis after inadequate response to biologics

  This study will try abrocitinib in adolescents and adults (≥12 years) with moderate-to-severe atopic dermatitis who didn't respond to or couldn't tolerate up to two biologic treatments to see how it works in routine care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.