A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

Korábbi kezelés

• Infections:
  • Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1.
  • History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
  • Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
  • Infection with HIV, hepatitis B, and/or hepatitis C
  • Evidence of active TB or inadequately treated latent TB.

Más betegség

• Medical Conditions:
• Have any of the following medical conditions:
• Skin Conditions:
  • Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.

Laborértékek

• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Other Conditions:
  • Documented history of skeletal dysplasia.
  • Documented history of retinal detachment.
  • History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
  • Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
  • Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
  • Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.
  • Prior/Concomitant Therapy:
  • Prior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.
  • Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.
  • Prior/Concurrent Clinical Study Experience:
  • Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

Egyéb

• Participants are excluded from the study if any of the following criteria apply:
• If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.

• No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
  • Disease Characteristics:
  • Participants who meet all of the following AD criteria:
• A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria[19]; and
• A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
• Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy
  • Other Inclusion Criteria:
  • Body weight ≥15 kg