A study to assess the safety and efficacy of abrocitinib compared with dupilumab in adult participants with moderate to severe atopic dermatitis.
- Conditions
- Moderate to severe atopic dermatitis (AD).MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-004013-13-IT
- Lead Sponsor
- PFIZER INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
1.Participants must be 18 years of age or older inclusive, at the time of signing the informed consent.
2.Participants who meet all of the following AD criteria:•Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed AD at the screening and baseline visits according to Hanifin and Rajka criteria for AD.•Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 consecutive weeks,or who have required systemic therapies for control of their disease within the past year. 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 (BSA>=10%, IGA>=3, EASI>=16 and PP-NRS severity score>=4 on the day of the baseline visit).3.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.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) OR•Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.•A WOCBP must have a negative highly sensitive 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 study intervention and at every site visit including the EOT and follow-up visits to confirm the participant has not become pregnant. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.•The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.4.Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.5.For the treatment of AD, the participant may use low- or medium-potency medicated and non-medicated topical therapy, with response to treatment remaining inadequate at baseline. The participant must also be willing and able to comply with standardized background topical therapy, as per protocol guidelines, throughout the remainder of the study.6.Participants willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.7.Participants must agree to avoid prolonged exposure to
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1.Other acute or chronic medical condition including laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the participant inappropriate for entry into this study.
2.The participant should 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 screening information indicate:
•Suicidal ideation associated with actual intent and a method or plan in the past year: 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: Yes” answer (for events that occurred in the past 5 years) 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.
•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.A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
4.Receiving anti-coagulants or medications known to cause thrombocytopenia (unless considered safe to stop and washout for the duration of the study).
5.Currently have active forms of other inflammatory skin diseases (ie, not AD) or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment.
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 6 months prior to Day 1;
•Have a known helminth infection;
•Have active chronic or acute skin infection requiring treatment with systemic antimicrobials within 2 weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1;
•A participant known to be infected with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
•Participants who are hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) positive, and hepatitis B surface antibody (HBsAb) positive at Screening will have reflex testing for hepatitis B Virus (HBV) deoxyribose nucleic acid (DNA). Participants who have HBV DNA above the lower limit of quantification (LLQ) are excluded. Participants who have HBV DNA negative or below LLQ may be randomized but will have HBV DNA testing repeated at Week 16 and Week 26 End of Treatment (EOT) visit, or Early Discontinuation (ED) visit, whichever is sooner.
•Have a history (single episode) of disse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method