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[M22-000]A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis)

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Yamazaki Hayato

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact for

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

July. 20, 2023

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area(BSA) of AD involvement at the Baseline Visit.
- Baseline weekly average of daily Worst Pruritus NRS >=4.
- Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable.

- Participants with current or past history of infection including:
--Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
-- One or more episodes of disseminated herpes simplex (including eczema herpeticum);
--Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test;
-- Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing);
-- Japan only: 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 participant an unsuitable candidate for the study;
-- COVID-19 infection: In participants who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic participants. Participants 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).
Participants may be rescreened if judged to be in good general health, as determined by the investigator based upon the medical history and physical examination.

- Evidence of Hepatitis B virus (HBV) or Hepatitis C virus(HCV).

- Any of the following medical diseases or disorders:
-- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
-- 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 gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or
significantly increased risk for gastrointestinal perforation per investigator judgment;
-- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or
gastric bypass surgery; participants 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.

Atopic Dermatitis

Double-Blind Treatment Period Dose A; Participants will be administered orally updadacitinib Dose A once daily (QD) for 12 weeks.
Double-Blind Treatment Period Dose B; Participants will be administered orally updadacitinib Dose B QD for 12 weeks.
Single-Blinded Treatment Period Arm B; Participants will be administered orally updadacitinib QD for 12 weeks.
Single-Blinded Treatment Period Arm D; Participants will be administered orally updadacitinib QD for 12 weeks.
Single-Blinded Treatment Period Arm A; Participants will be administered orally updadacitinib QD for 12 weeks.
Single-Blinded Treatment Period Arm C; Participants will be administered orally updadacitinib QD for 12 weeks.

Percentage of Participants Achieving EASI 90 at Week 24

Percentage of Participants Achieving EASI 75/90/100 at Week 12
Percentage of Participants Achieving EASI 75/100 at Week 24
Percentage of Participants Achieving EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1 at Week 12/24
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 up to Week 24
Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4 up to Week 24
Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1 up to Week 24
Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4 up to Week 24
Percentage of Participants Achieving DLQI of 0 or 1 up to Week 24

July. 07, 2023

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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