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New treatment option for Atopic Dermatitis
Official title A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
ClinicalTrials.gov ID: NCT06389136
What this study is testing
What is Upadacitinib 15mg Dose?
Upadacitinib 15mg Dose is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for atopic dermatitis.
Also referred to as ABT-494, RINVOQ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 63
You may be able to join if
- 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 people (\>= 50% of the overall study population)
You likely can't join if
- 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...
- 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);
See the full eligibility 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 people (\>= 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...
- 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...
- 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 people 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 people. people with mild/moderate COVID-19...
- 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; people with a history of gastric banding/segmentation are...
- History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Chula Vista, California, United States
- Encino, California, United States
- Fountain Valley, California, United States
- Greenbrae, California, United States
- Mission Viejo, California, United States
- Oceanside, California, United States
- Pasadena, California, United States
- Redwood City, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Thousand Oaks, California, United States
- New Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Brandon, Florida, United States
- Coral Springs, Florida, United States
- Doral, Florida, United States
- Fort Lauderdale, Florida, United States
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 63 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Fayetteville, Arkansas, United States; Chula Vista, California, United States; Encino, California, United States; Fountain Valley, California, United States and 102 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.