A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis (NCT06461897) — Poland Trial Details

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Upadacitinib: Oral Tablet or Oral Solution

Dupilumab: Subcutaneous Injection

Study summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement.

Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab.

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 clinical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Sex

ALL

Min age

2 Years

Max age

11 Years

Healthy volunteers

No

Inclusion Criteria: * A minimum weight of 10 kg and weight and height \> 5th percentile for their age according to local standard growth charts at the Baseline Visit. * Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline. * Eczema Area and Severity Index (EASI) score \>= 16; vIGA-AD score \>= 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the Randomized Cohort should have severe AD \[vIGA-AD = 4\]); \>= 10% Body Surface Area of AD involvement at the Baseline Visit; and Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) \>= 4. * Participant must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual participant. All applicable criteria for each individual participant should be reported): * To be included in the Randomized Cohort (Note: Participants must have severe AD \[vIGA-AD = 4\] in countries where dupilumab is approved only for severe AD.): 1. \[For all countries except US\] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, Scoring Atopic Dermatitis (SCORAD) \> 50, EASI score \> 21, or vIGA-AD \> 3). 2. For dupilumab-naïve participants: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks). 3. History of inadequate response to 2 or more courses of oral corticosteroid therapy given for \>= 14 days within 6 months prior to Screening or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation. 4. For dupilumab-exposed participants: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges \[not safety- or efficacy-related\] precluding the participants continued access to dupilumab). * To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort: * Previous inadequate response or intolerance to dupilumab OR * Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI. Exclusion Criteria: * Current or past history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or which would interfere with the appropriate assessment of AD lesions. * Have used topical treatments for AD (except for topical emollient treatments) including but not limited to TCS, TCI, or topical phosphodiesterase type 4 (PDE-4) inhibitors, within 7 days of the Baseline Visit or any the following prohibited concomitant AD treatments within the specified timeframes below prior to the Baseline Visit: * Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks; * Dupilumab within 8 weeks; * Targeted biologic treatments (other than dupilumab) within 5 half-lives (if known) or within 12 weeks, whichever is longer; * Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks. * Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality. * For Randomized Cohort: 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.

Primary outcome measure(s)

Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US) — At Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points (US and China only, descriptive) — Week 16
The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: * 0 - Clear: No inflammatory signs of AD; * 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; * 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; * 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; * 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Number of Participants with Adverse Events (AEs) — Up to Approximately Week 172
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (150)

Facility	City	Region	Status
Applied Research Center and Wellness Clinic /ID# 268547	Little Rock	Arkansas	Recruiting
Stanford University School of Medicine /ID# 269622	Palo Alto	California	Recruiting
Integrative Skin Science and Research /ID# 265108	Sacramento	California	Recruiting
Clearlyderm Dermatology - West Boca /ID# 266323	Boca Raton	Florida	Completed
Pediatric Skin Research - Coral Gables /ID# 266308	Coral Gables	Florida	Recruiting
Neoclinical Research - Hialeah /ID# 269694	Hialeah	Florida	Completed
Emory University School Of Medicine - Atlanta /ID# 268832	Atlanta	Georgia	Recruiting
Cleaver Medical Group Dermatology /ID# 265099	Dawsonville	Georgia	Completed
Aeroallergy Research Laboratory /ID# 267247	Savannah	Georgia	Recruiting
Treasure Valley Medical Research /ID# 266838	Boise	Idaho	Recruiting
Northwestern University Feinberg School of Medicine /ID# 265117	Chicago	Illinois	Recruiting
Sneeze Wheeze & Itch Associates /ID# 267238	Normal	Illinois	Recruiting
Dawes Fretzin /ID# 265097	Indianapolis	Indiana	Recruiting
Equity Medical, LLC /ID# 268270	Bowling Green	Kentucky	Recruiting
Maryland Allergy & Asthma Center /ID# 268032	Lanham	Maryland	Recruiting
DermAssociates - Rockville /ID# 266457	Rockville	Maryland	Completed
Washington University School of Medicine - St. Louis /ID# 268545	St Louis	Missouri	Recruiting
Skin Specialists /ID# 266331	Omaha	Nebraska	Recruiting
DOCS Clinical Research - Canal Winchester /ID# 268271	Canal Winchester	Ohio	Recruiting
Wright State Physicians Health Center /ID# 268841	Fairborn	Ohio	Recruiting
Oregon Health and Science University /ID# 266483	Portland	Oregon	Recruiting
Medical University of South Carolina /ID# 265113	Charleston	South Carolina	Recruiting
International Clinical Research - Tennessee /ID# 268548	Murfreesboro	Tennessee	Completed
Arlington Research Center, Inc /ID# 266330	Arlington	Texas	Recruiting
3A Research - East location /ID# 267622	El Paso	Texas	Recruiting
Prime Clinical Research - Mansfield - East Broad Street /ID# 268042	Mansfield	Texas	Recruiting
Texas Dermatology and Laser Specialists /ID# 267249	San Antonio	Texas	Recruiting
Progressive Clinical Research - San Antonio /ID# 267262	San Antonio	Texas	Recruiting
Jordan Valley Dermatology & Research Center /ID# 267092	South Jordan	Utah	Recruiting
West Virginia University Hospitals /ID# 265114	Morgantown	West Virginia	Recruiting
Medical College Of Wisconsin - Milwaukee Campus /ID# 267236	Milwaukee	Wisconsin	Recruiting
Sanatorio 9 de Julio /ID# 267678	San Miguel de Tucumán	Tucumán Province	Recruiting
Conexa Investigacion Clinica /ID# 268728	Buenos Aires	Argentina	Recruiting
Instituto de Neumonologia y Dermatologia /ID# 266146	Buenos Aires	Argentina	Recruiting
Psoriahue - Buenos Aires /ID# 267737	Buenos Aires	Argentina	Recruiting
The Children's Hospital at Westmead /ID# 265430	Westmead	New South Wales	Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 267149	Clayton	Victoria	Recruiting
Institute for Skin, Health and Immunity /ID# 266158	Mitcham	Victoria	Recruiting
Medizinische Universitaet Graz /ID# 262741	Graz	Styria	Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427	Salzburg	Austria	Recruiting

+ 110 more sites — see the full list on the official registry below.

On this site

📄 Rinvoq (upadacitinib) drug profile → 📄 Dupixent (dupilumab) drug profile →

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