A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in Study M16-046

A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in Study M16-046 - M19-850

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55265

Enrollment

Registered

2020-03-17

Start date

2020-05-29

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis Eczema

Interventions

The study consists of a baseline visit (Week 24 [last on-treatment visit] of M16-046 study)and a 52-week open-label treatment period. The treatment period can be extended until regulatory approval a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Subjects should have successfully completed treatment in the M16-046 study, without developing any permanent discontinuation criteria. • Subject is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the M16-046 study to continue treatment in the long term extension study.

Exclusion criteria

Exclusion criteria: • Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Design outcomes

Primary

Measure	Time frame
Treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of special interest (AESI), AEs leading to discontinuation of study drug; vital signs, laboratory tests, and physical examination findings.	—

Secondary

Measure	Time frame
- Change and percent change from Baseline in worst pruritus numerical rating scale (NRS) - Change and percent change from Baseline in EASI - Proportion of subjects achieving EASI 75/90/100 - Evaluation of known and/or novel disease-related or drug-related biomarkers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)