A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (NCT03568318) — UK Trial Details

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

PlaceboUpadacitinibTopical corticosteroids (TCS)

Placebo: Tablets taken orally once a day

Upadacitinib: Tablets taken orally once a day

Topical corticosteroids (TCS): Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.

Study summary

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Eligibility

Sex

ALL

Min age

12 Years

Max age

75 Years

Healthy volunteers

No

Inclusion Criteria: * Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and \< 18 years of age * Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria. * Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4. * Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. * Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit Exclusion Criteria: * Prior exposure to any Janus kinase (JAK) inhibitor * Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study * Requirement of prohibited medications during the study * Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions * Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Primary outcome measure(s)

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 — Baseline and 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.
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 — Baseline and 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.

Trial sites (193)

Facility	City	Region
Total Skin and Beauty Derm Ctr /ID# 200548	Birmingham	Alabama
Clinical Research Center AL /ID# 201865	Birmingham	Alabama
ACCEL Research Sites /ID# 213364	Birmingham	Alabama
Advanced Dermatology and Skin Care Centre /ID# 213550	Mobile	Alabama
Alliance Dermatology and MOHs Center, PC /ID#200540	Phoenix	Arizona
Arizona Research Center, Inc. /ID# 200546	Phoenix	Arizona
Clear Dermatology & Aesthetics Center /ID# 201257	Scottsdale	Arizona
University of Arizona /ID# 201059	Tucson	Arizona
Bakersfield Derma & Skin Cance /ID# 200892	Bakersfield	California
Mosaic Dermatology /ID# 200553	Beverly Hills	California
University of California Irvine /ID# 200902	Irvine	California
Therapeutics Clinical Research /ID# 200593	San Diego	California
Stanford University /ID# 200597	Stanford	California
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822	Aurora	Colorado
Colorado Center for Dermatology, PLLC /ID# 203626	Centennial	Colorado
Duplicate_Western States Clinical Research, Inc. /ID# 201702	Wheat Ridge	Colorado
Dermatology Physicians of Connecticut /ID# 201004	Shelton	Connecticut
Clearlyderm Dermatology /ID# 207709	Boca Raton	Florida
Skin Care Research, LLC /ID# 200812	Boca Raton	Florida
Clinical Research of West Florida, Inc /ID# 203643	Clearwater	Florida
Florida Academic Centers Research and Education /ID# 200544	Coral Gables	Florida
Tory P Sullivan, MD PA /ID# 201174	North Miami Beach	Florida
Park Avenue Dermatology, PA /ID# 201012	Orange Park	Florida
Precision Clinical Research /ID# 208734	Sunrise	Florida
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628	Boise	Idaho
Northwestern University Feinberg School of Medicine /ID# 201646	Chicago	Illinois
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556	Skokie	Illinois
DuPage Medical Group /ID# 202065	Wheaton	Illinois
Deaconess Clinic Downtown /ID# 201001	Evansville	Indiana
Indiana University /ID# 200515	Indianapolis	Indiana
Epiphany Dermatology of Kansas LLC /ID# 203026	Overland Park	Kansas
ORA, Inc. /ID# 202824	Andover	Massachusetts
Tufts Medical Center /ID# 200570	Boston	Massachusetts
Beth Israel Deaconess Medical Center /ID# 200545	Boston	Massachusetts
Clin Res Inst of Michigan, LLC /ID# 208020	Chesterfield	Michigan
Michigan Center for Research Company /ID# 200560	Clarkston	Michigan
MediSearch Clinical Trials /ID# 201006	Saint Joseph	Missouri
Skin Specialists, PC /ID# 200573	Omaha	Nebraska
Dartmouth-Hitchcock Medical Center /ID# 200918	Lebanon	New Hampshire
Psoriasis Treatment Center of Central New Jersey /ID# 200714	East Windsor	New Jersey

+ 153 more sites — see the full list on the official registry below.

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