JRCT ID: jRCT2061240026
Registered date:21/06/2024
Atopic Dermatitis: A Study of Upadacitinib in Adult Subjects with Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Atopic Dermatitis |
Date of first enrollment | 12/07/2024 |
Target sample size | 32 |
Countries of recruitment | United States of America,Japan,Puerto Rico,Japan,Colombia,Japan,South Korea,Japan |
Study type | Interventional |
Intervention(s) | 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 Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B 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. |
Outcome(s)
Primary Outcome | Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) [Time Frame: At Week 8] |
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Secondary Outcome | Percentage of participants who achieve EASI 90 [Time Frame: At Week 8] Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 [Time Frame: At Week 8] Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 [Time Frame: At Week 4] |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 63age old |
Gender | Both |
Include 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 >= 16 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. -Documented history of inadequate response to dupilumab treatment after at least 6 months of current use (last dose within 2 weeks prior to Baseline) -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. |
Exclude 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; 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. -Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV) -Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, (note: include the following only for new protocols) 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; subjects with a history of gastric banding/segmentation are not excluded; -History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix; |
Related Information
Primary Sponsor | Otani Tetsuya |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06389136 |
Contact
Public contact | |
Name | Contact for Patients and HCP |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie. G.K. |
Scientific contact | |
Name | Tetsuya Otani |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie G.K. |