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A Long-Term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older with Moderate to Severe Eczema
EU CTIS ID: 2023-509124-18-00
What this study is testing
To evaluate long-term safety of abrocitinib in children ≥2 years of age with moderate-to-severe disease
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants who have completed the treatment phase of the qualifying parent study (age 2 to <12 years old).
- Children aged 6 to <12 years at the time of informed consent/assent.
- Participants who meet all of the following AD criteria: A documented diagnosis of chronic AD for at least 6 months 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.
- Body weight ≥15 kg
You likely can't join if
- 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.
- Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.
- Previous administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, of Day 1.
- Hepatic and/or renal and/or hematological abnormalities defined as: AST >2 x ULN Hemoglobin <10 g/dL ALT >2 x ULN ANC <1000/mm3 Total bilirubin ≥1.5 x ULN ALC <500/mm3 eGFR 60 mL/min/1.73 m2 Platelets <150,000 /mm3
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9.
See the full eligibility criteria
Who can join
- Participants who have completed the treatment phase of the qualifying parent study (age 2 to <12 years old).
- Children aged 6 to <12 years at the time of informed consent/assent.
- Participants who meet all of the following AD criteria: A documented diagnosis of chronic AD for at least 6 months 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.
- Body weight ≥15 kg
What rules you out
- 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.
- Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.
- Previous administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, of Day 1.
- Hepatic and/or renal and/or hematological abnormalities defined as: AST >2 x ULN Hemoglobin <10 g/dL ALT >2 x ULN ANC <1000/mm3 Total bilirubin ≥1.5 x ULN ALC <500/mm3 eGFR 60 mL/min/1.73 m2 Platelets <150,000 /mm3
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9.
- Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.
- Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria. Available results from assessments performed as part of the Week 12 visit of the parent study should be evaluated to determine eligibility and appropriateness of the participant to be enrolled. Clinically significant abnormalities on physical examination at Week 12 visit or any unresolved, clinically significant abnormality from results of ECGs (if applicable), safety laboratory assessments, or vital signs measurements recorded in the parent study that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study, are exclusionary.
- Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
- 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.
- Have any of the following medical conditions: 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. - Known or suspected infection with HIV, hepatitis B, and/or hepatitis C (Section 8.3.6). - Evidence of active TB or inadequately treated latent TB. 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. 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- Japan
- India
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; Japan; India; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.