Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
NCT04564755
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 12 years of age or older
- Clinical diagnosis of chronic atopic dermatitis for at least 6 months
- Inadequate treatment options with available, approved medicated topical and systemic therapies for moderate to severe atopic dermatitis
- Moderate to severe atopic dermatitis as indicated by at least one of the following: IGA ≥3; EASI ≥16
- Not eligible for participation in any ongoing clinical trial of abrocitinib, including lack of access due to geographical limitations
- Medical, psychiatric, or laboratory abnormality that may increase the risk associated
with study participation
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
malignancies, current or history of certain infections, lymphoproliferative disorders
and other medical conditions at the discretion of the investigator
- Require treatment with prohibited medications during the study
- Discontinued prior treatment with any systemic JAK inhibitor due to safety or
tolerability issues
- 12 to <18 years old without documented evidence of having received at least one dose
of the varicella vaccine or without evidence of prior exposure to varicella zoster
virus based on serological test
- Pregnant or breastfeeding women or women of childbearing potential who are sexually
active and unwilling to use contraception
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis | ||||
| Brief Summary | This is a multi-center, expanded access protocol to provide access to the investigational product, abrocitinib, to adolescent and adult patients with moderate to severe atopic dermatitis who have inadequate treatment options with available and approved medicated topical and systemic therapies and who are otherwise ineligible for participation in clinical studies with abrocitinib. | ||||
| Detailed Description | This is a multi-center expanded access protocol (EAP) for the treatment of up to approximately 500 adult and adolescent (defined as age < 18 years) patients with moderate to severe atopic dermatitis for whom standard, approved medicated topical and systemic treatment options are inadequate and who would be suitable candidates for a trial of abrocitinib for potential treatment of moderate to severe atopic dermatitis. The study will also collect safety and exploratory efficacy data. Participants who meet the inclusion criteria and none of the exclusion criteria may be enrolled into the EAP to receive open-label oral treatment with abrocitinib. | ||||
| Study Type | Expanded Access | ||||
| Expanded Access Type | Treatment IND/Protocol | ||||
| Intervention | Drug: abrocitinib
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | Australia, Canada, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04564755 | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | May 2021 | ||||