A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Topical Corticosteroids (TCS); Drug: Upadacitinib; Drug: Placebo for upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03661138

2022-002777-29 (EudraCT Number)

M17-377

Details and patient eligibility

About

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

Enrollment: 272 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus.
• Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.
• Able to tolerate topical corticosteroids for atopic dermatitis lesions.

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.
• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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272 participants in 4 patient groups

Arm A

Experimental group

Description:

Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).

Treatment:

Drug: Upadacitinib

Drug: Topical Corticosteroids (TCS)

Arm B

Experimental group

Description:

Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).

Treatment:

Drug: Upadacitinib

Drug: Topical Corticosteroids (TCS)

Arm C

Experimental group

Description:

Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.

Treatment:

Drug: Placebo for upadacitinib

Drug: Upadacitinib

Drug: Topical Corticosteroids (TCS)

Arm D

Experimental group

Description:

Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.

Treatment:

Drug: Placebo for upadacitinib

Drug: Upadacitinib

Drug: Topical Corticosteroids (TCS)