ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- Conditions
- Atopic dermatitisatopic eczema10014982
- Registration Number
- NL-OMON52169
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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 Guidance appendix during the intervention 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 a
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 (H
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Not applicable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Incidence of treatment-emergent adverse events (AEs) and serious adverse<br /><br>events (SAEs).<br /><br>• Incidence of serious adverse events (SAEs) and AEs leading to discontinuation.<br /><br>• Incidence of serious infections, defined as any infection (viral, bacterial,<br /><br>and fungal) requiring hospitalization or parenteral antimicrobials.</p><br>