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Janus Kinase (JAK) Inhibitor

Upadacitinib for Eczema (Switch-Up Trial)

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 (calculated from the 7 consecutive days immediately preceding the Baseline Visit with a minimum of 4 daily scores out of the 7 days), Documented history of inadequate response to dupilumab treatment after at least 6 months of current use (last dose within 2 weeks prior to Baseline), Participant 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 (subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if initiated before the Screening visit)

Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria

Must not have

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, Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period (for Japan), 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), 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 (include only for new protocols), 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 8

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a drug called upadacitinib for treating moderate to severe atopic dermatitis (AD). Participants will be given different doses of upadacitinib and monitored for

Who is the study for?

Adults aged 18-64 with moderate to severe atopic dermatitis (AD) who haven't responded well to Dupilumab. Participants must not have certain infections, a history of severe herpes, active tuberculosis, other skin diseases requiring systemic treatment, or HIV. Those recently infected with COVID-19 must meet specific recovery criteria.

What is being tested?

The trial is testing the effectiveness and safety of Upadacitinib at two different doses in adults with AD that's hard to treat. It involves an initial period where participants receive one dose level followed by a possible adjustment after 2 weeks based on their response.

What are the potential side effects?

Potential side effects may include increased risk of infection due to immune system suppression, liver issues, blood clots, and allergic reactions among others. Regular medical assessments and blood tests will monitor for these during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had chronic atopic dermatitis for over 3 years and meet specific medical criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants who simultaneous achieve at least 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)

Secondary study objectives

Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1

Percentage of participants who achieve EASI 90

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Period 2 Open Label: Upadacitinib ≥ EASI 75 ResponseExperimental Treatment2 Interventions

Participants that were receiving Upadacitinib Dose A or Dose B and completed Period 1, will continue to receive the same oral doses of Upadacitinib in Period 2 with a clinical response of ≥ EASI 75 at Week 8

Group II: Period 2 Open Label: Upadacitinib < EASI 75 responseExperimental Treatment1 Intervention

Participants that were receiving Upadacitinib Dose A or Dose B and completed Period 1, will be allocated or continue to receive oral doses of Upadacitinib Dose B in Period 2 with a clinical response of \< EASI 75 at Week 8

Group III: Period 2 Open Label: Dupilumab ≥ EASI 75 ResponseExperimental Treatment1 Intervention

Participants that were receiving Dupilumab Dose A and completed Period 1, will continue to receive Dupilumab Dose A SC injection in Period 2 with a clinical response of ≥ EASI 75 at Week 8

Group IV: Period 2 Open Label Period: Dupilumab < EASI 75 ResponseExperimental Treatment1 Intervention

Participants that were receiving Dupilumab Dose A and completed Period 1, will receive oral doses of Upadacitinib Dose A in Period 2 with a clinical response of \< EASI 75 at Week 8

Group V: Period 1: Upadacitinib Open Label TreatmentExperimental Treatment2 Interventions

Participants randomly assigned to receive Upadacitinib Dose A tablet once per day. Based on clinical response, participants randomized to Upadacitinib Dose A will have their dose increased to Upadacitinib Dose B starting at Week 2.

Group VI: Period 1: Dupilumab Open Label TreatmentExperimental Treatment1 Intervention

Participants randomly assigned to receive Dupilumab Dose A SC injection once every other week for 8 weeks.

0 / 3Eligibility criteria met