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Brief summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventional study
- 1
- 2
- 3
- 4
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
From 18 Years to 63 Years.
Inclusion Criteria:
- Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject
meets Hanifin and Rajka criteria.
- Participant meets all the following disease activity criteria at Baseline Visit:
- Eczema Area and Severity Index (EASI) score >= 12;
- validated Investigator´s Global Assessment for AD (vIGA-AD) score >= 3;
- Body surface area (BSA) involvement of >= 10% in a majority of subjects (>= 50%
of the overall study population)
- Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS)
>= 4. Note: The Baseline weekly average of daily WP-NRS will be calculated from
the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4
daily scores out of the 7 days is needed.
- Inadequate response to dupilumab treatment after at least 4 months of current
use.
- Particpant has applied a topical emollient (an additive-free, bland emollient
moisturizer) twice daily for at least 7 days before the Baseline Visit and for
the duration of the study. Note: Subject may use prescription moisturizers or
moisturizers containing ceramide, urea, filaggrin degradation products or
hyaluronic acid if such moisturizers were initiated before the Screening visit.
Exclusion Criteria:
- Meeting any of the following conditions at Baseline:
- Other active skin diseases or skin infections (bacterial, fungal, or viral)
requiring systemic treatment within 4 weeks of the Baseline Visit or would
interfere with assessment of AD lesions;
- Two or more past episodes of herpes zoster, or one or more episodes of
disseminated herpes zoster;
- One or more past episodes of disseminated herpes simplex (including eczema
herpeticum);
- HIV infection defined as confirmed positive anti- HIV Ab test;
- Participants with current or past history of infection including, Evidence of
Hepatitis B virus (HBV) or Hepatitis C virus (HCV);
- Active TB or meet TB exclusionary parameters (specific requirements for TB
testing are provided in the operations manual);
- For Japan: Positive result of beta-D-glucan (screening for Pneumocystis
jirovecii infection) or two consecutive indeterminate results of beta-D-glucan
during the Screening Period;
- Active infection(s) requiring treatment with intravenous anti-infectives within
30 days, or oral/intramuscular anti-infectives within 14 days prior to the
Baseline Visit;
- Chronic recurring infection and/or active viral infection that, based on the
investigator's clinical assessment, makes the subject an unsuitable candidate
for the study;
- COVID-19 infection: In subjects who tested positive for COVID-19, at least 5
days must have passed between a COVID-19 positive test result and the Baseline
visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection
can be enrolled if fever is resolved without use of antipyretics for 24 hours
and other symptoms improved, or if 5 days have passed since the COVID-19
positive test result (whichever comes last). Subjects may be rescreened if
deemed appropriate by the investigator based upon the subject's health status.
- At Baseline any of the following medical diseases or disorders:
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction,
coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;
- Any unstable clinical condition which, in the opinion of the investigator would
put the subject at risk by participating in the protocol;
- Diagnosed active parasitic infection, suspected or high risk of parasitic
infection unless clinical (and if necessary) laboratory assessment have ruled
out active infection before randomization;
- History of an organ transplant which requires continued immunosuppression;
- History of an allergic reaction or significant sensitivity to constituents of
the study drug (and its excipients) and/or other products in the same class;
- History of GI perforation (other than due to appendicitis or mechanical
injury), diverticulitis, or significantly increased risk for GI perforation per
investigator judgment;
- Conditions that could interfere with drug absorption including but not limited
to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy;
subjects with a history of gastric banding/segmentation are not excluded;
- History of malignancy except for successfully treated NMSC or localized
carcinoma in situ of the cervix.
