This expanded access protocol will provide access to abrocitinib until it becomes commercially available to patients

Phase 1

• Conditions: Moderate to severe atopic dermatitis (AD); MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-003610-12-GR
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-08
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Age:
1. Participants 12 years of age or older at the time of signing the informed consent. Adolescent participants below the age of 18 years(or country -specific age of majority) will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only participants 18 years of age (or country-specific age of majority) or older at the time of signing of informed consent may be enrolled.
2. Participants who meet all of the following atopic dermatitis criteria:
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 6months prior to Day 1 and has confirmed atopic dermatitis at the Screening and Baseline visits according to Hanifin and Rajka criteria for AD.10 Refer to protocol. -Inadequate treatment options for moderate to severe AD due to history of inadequate response or intolerance to treatment with available approved medicated topical and systemic therapies for the treatment of AD, underlying conditions that preclude use of available approved medicated topical and systemic therapies for the treatment of AD, or lack of availability or access to approved medicated topical and systemic therapies for the treatment of AD.
NOTE: Medicated topical therapy is defined as a topical product that contains an active pharmaceutical ingredient indicated for the treatment of AD (irrespective of whether it is an over the counter [OTC] or prescribed product).
- Moderate to severe AD as indicated by meeting at least 1of the following on the day of the baseline visit: IGA =3; EASI =16.
3. Participants who are ineligible for participation in any ongoing clinical trial of abrocitinib, including lack of access due to geographical limitations.
4. Participants and, as applicable, parents/legal guardians of age of minority participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Sex:
5. Male or Female
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to protocol.
a. Male participants: No contraceptive measures are required.
b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP) (Refer to the definition in the Contraceptive Guidance appendix).
OR
- Is a WOCBP.A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, as described in Contraceptive Guidanceappendixduring theintervention period and for at least 28 days after the last dose of abrocitinib. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of abrocitinib.
- A WOCBP must have a negative highly sensitive(refer to the Clinical Laboratory Tests appendix)serum pregnancy test at the Screening visit. A urine pregnancy test with a sensitivity of at least 25 mIU/mL, will be performed before the first dose of abrocitinib and at every site visit including the EOT and Follow-up/EOS visits to confirm the participant has not become pregnant. If a urine test cannot be confirmed as negative (eg, an ambiguous r

Exclusion Criteria

Medical Conditions:
1. Other medical or psychiatric condition including recent(within the past year)or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
2. The participant must have a risk assessment done by a qualified mental health professional (MHP) to assess whether it is safe to participate in the trial if the participant’s responses on any of the screening instruments or other information from the screening period indicate:
- Suicidal ideation associated with actual intent and a method or plan in the past year for adults or at any time in their lifetime for adolescents ages =12 and <18years: Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS).
- Previous history of suicidal behaviors in the past 5 years for adults or at any time in their lifetime for adolescents ages =12 and <18 years: Yes” answer (in the past 5 years for adults or at any time in their lifetime for adolescents) to any of the suicidal behavior items of the C-SSRS.
- Any lifetime history of serious or recurrent suicidal behavior (non-suicidal self-injurious behavior is not a trigger for a risk assessment unless in the investigator’s judgement it is indicated).
- Clinically significant depression: Patient Health Questionnaire 8 items (PHQ-8) when the total score is=15 for adults or=10for adolescents ages =12 and <18years.
- The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.
- In the investigator’s judgment a risk assessment or exclusion is required.
3. Have increased risk of developing venous thromboembolism, eg, deep vein thrombosis or pulmonary embolism:
- History of venous thromboembolism, or
- First-degree relative with unprovoked venous thromboembolism (ie, without known underlying cause such as trauma, surgery, immobilization, prolonged travel, pregnancy, hormone use, or plaster cast), that would suggest participant is at increased risk of inherited coagulation disorder (eg,Factor V Leiden).
4. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
5. Receiving anti-coagulants or medications known to cause thrombocytopenia (unless considered safe to stop and washout for the duration of the study).
6. Have a history of any lymphoproliferative disorder such as Epstein Barr virus (EBV), related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
7. Infection history:
- Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6months prior to Day1;
- Have active chronic or acute skin infection requiring treatment with systemic antimicrobials within 2weeks prior to Day1, or superficial skin infections within 1week prior to Day1;
- A participant known to be infected with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• Screening for Hepatitis B will include testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). Participants who are HBsAg negative and HBcAb positive will have testing for HBsAb. Participants who are HBsAg negative, HBcAb positive, and HBsAb positive at Screening w

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide access to abrocitinib to adolescent and adult patients with or without background topical therapy who have inadequate treatment options due to inadequate response or intolerance to available approved medicated topical and systemic therapies and need abrocitinib as a possible treatment regimen for moderate to severe AD.;Secondary Objective: To gain additional safety and tolerability data for abrocitinib 100 mg and 200 mg once daily (QD) with or without background topical therapy in adolescent and adult participants with moderate to severe AD in a ‘real world’ clinical setting.<br>;Primary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Endpoints : <br>All participants who receive abrocitinib (safety population) will be included in the safety analyses. All safety data will be summarized descriptively. Safety endpoints for the study include:<br>•Treatment emergent AEs and SAEs;<br>•Withdrawals from active treatment due to AEs and SAEs;<br>•Serious infections, defined as any infection (viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.<br>;Timepoint(s) of evaluation of this end point: Not Applicable