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A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

Phase 4
Conditions
Atopic dermatitis
eczema
10014982
Registration Number
NL-OMON53671
Lead Sponsor
AbbVie B.V.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
14
Inclusion Criteria

- Male or female subjects >= 18 and < 65 years of age at the screening visit
- Chronic AD with onset of symptoms at least 3 years prior to Baseline and
subject meets Hanifin and Rajka criteria - Candidate for systemic treatment

Exclusion Criteria

- Prior exposure to any JAK inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study treatment
- Female subject who is pregnant, breastfeeding, or considering pregnancy
during the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoints are:<br /><br>- Achievement of EASI 90 at Week 24.</p><br>
Secondary Outcome Measures
NameTimeMethod
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