臨床研究等提出・公開システム

[M16-047] A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

AD Up

Otani Tetsuya

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

completed

Oct. 24, 2018

Interventional

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids. At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, ans participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. Participants from M16-045 or M18-891 and participants from M16-047 will have the opportunity to enroll into the blinded LTE period after reaching Week 260 in their respective studies.

treatment purpose

3

- 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

- 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

Both

Atopic Dermatitis

investigational material(s)
Generic name etc : ABT-494 / M16-047
INN of investigational material : Upadacitinib
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : It is administered orally once daily along with TCS.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
- Proportion of subjects achieving at least a 75% reduction in
Eczema Area and Severity Index (EASI 75) from Baseline at
Week 16;
- Proportion of subjects achieving validated Investigator Global
Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at
least two grades of reduction from Baseline at Week 16.

efficacy
- Proportion of participants achieving an improvement (reduction) of 4 or more in worst pruritus Numerical Rating Scale (NRS) at week 16
- Proportion of participants achieving EASI 90 at week 16
- Proportion of subjects achieving EASI 75 at Week 4
- Proportion of subjects achieving EASI 100 at Week 16 in certain arms
- Proportion of subjects achieving vIGA-AD of 0 at Week 16 in certain arms

+81-3-5773-5570

July. 06, 2018