This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of Participants Achieving both 90% Eczema Area and Severity Index
(EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1) at
week 16.
Secondary outcome
- Percentage of Participants Achieving an improvement in Worst Pruritus
Numerical Rating Scale (WP-NRS) 4 among those with Baseline WP-NRS
4 at week 16
- Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale
of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1 up to week 16
- Percentage of Participants Achieving 75% of Eczema Area and Severity Index
(EASI 75) at week 2
- Percentage of Participants Achieving 100% of Eczema Area and Severity Index
(EASI 100) at week 16
- Percentage of Participants Achieving at least 90% of Eczema Area and Severity
Index (EASI 90) up tp week 16
Background summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching
due to inflammation of the skin. Therapies spread over the skin may not be
enough to control the AD in trial participants who require systemic
anti-inflammatory treatment.
Study objective
This study compares upadacitinib to dupilumab in adolescent and adult
participants with moderate to severe AD who have inadequate response to
systemic therapies. Adverse events and change in the disease activity will be
assessed.
Study design
Randomized, open label, blinded assessor, parallel group study
Intervention
Participants will receive upadacitinib oral tablets once daily or dupilumab as
per its label for 32 weeks and followed for 30 days.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care . Participants will attend regular visits during the
study at a hospital or clinic. The effect of the treatment will be checked by
medical assessments, blood tests, checking for side effects and completing
questionnaires.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
o Subjects must be at least >= 12 years old and <= 64 years old at Screening
Visit. Adolescent subjects (between >= 12 and < 18 years of age) may be enrolled
only if there is local approval for dupilumab in this age group.
o Body weight must be >= 40 kg at the Baseline Visit for subjects between >= 12
and <=18 years of age, unless there are higher weight requirements per the local
approved label for dupilumab, in which case the more restricted requirement
must be followed.
o Chronic AD with onset of symptoms at least 3 years prior to baseline and
subject meets Hanifin and Rajka criteria
o EASI score >= 16; vIGA-AD score >= 3 and >= 10% BSA of AD involvement at the
Baseline Visit;
o Baseline weekly average of daily Worst Pruritus NRS >= 4.
o Documented history of inadequate response to previous systemic treatment
defined as documented history of previous inadequate response to at least one
prior systemic treatment for AD OR for whom other systemic treatments are
otherwise medically inadvisable (e.g., because of important side effects or
safety risks).
Exclusion criteria
o Prior exposure to any oral or topical JAK inhibitor (including but not
limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], ruxolitinib [Jakafi®
or Opzelura®], baricitinib [Olumiant®], peficitinib [Smyraf®], abrocitinib
[Cibinqo®], and filgotinib [Jyseleca®]), fedratinib [Inrebic®], and
deucravacitinib [Sotyktu*])
o Prior exposure to dupilumab, tralokinumab, or lebrikizumab
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-002482-15-NL |
| ClinicalTrials.gov | NCT05601882 |
| CCMO | NL82972.028.22 |