A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- Conditions
- Atopic dermatitisatopic eczema10014982
- Registration Number
- NL-OMON49637
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 8
Participants are eligible to be included in the study only if all of the
following criteria apply:
Age
1. Participants must be 18 years of age or older inclusive, at the time of
signing the informed consent.
Type of Participant and Disease Characteristics
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 1 year prior to Day 1 and has confirmed atopic dermatitis at the
screening and baseline visits according to Hanifin and Rajka criteria for AD.
Refer to Appendix 9.
* 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).
Sex
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) (see definition in Appendix
4)
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 (Appendix 2) 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 A
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 b
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Response based on achieving at least a 4-point improvement in the severity of<br /><br>Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 2.<br /><br>- Response based on achieving the Eczema Area and Severity Index (EASI)-75<br /><br>(*75% improvement from baseline) at Week 4. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Key Secondary<br /><br>Response based on achieving the Eczema Area and Severity Index (EASI) 75 (*75%<br /><br>improvement from baseline) at Week 16.<br /><br><br /><br>For a complete list of objectives and endpoints, please see section 3 of the<br /><br>protocol. </p><br>