This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data. 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are:
- Achievement of EASI 90 at Week 24.
Secondary outcome
The secondary endpoints are: - Achievement of EASI 75 / 100 at Week 24. -
Achievement of EASI 75 / 90 / 100 at Week 12. - Achievement of EASI 90 and
Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at
Baseline at Week 12 and week 24. - Achievement of vIGA-AD of 0 or 1 at Week 12.
- Achievement of vIGA-AD of 0 or 1 at Week 24. - Achievement of an improvement
(reduction) in Worst Pruritus (NRS >= 4 for subjects with Worst Pruritus NRS >= 4
at Baseline at Week 12. - Achievement of an improvement (reduction) in Worst
Pruritus NRS >= 4 for subjects with Worst Pruritus NRS >= 4 at Baseline at Week
24. - Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst
Pruritus NRS > 1 at Baseline at Week 12. - Achievement of Worst Pruritus NRS
of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24. -
Achievement of an improvement (reduction) from Baseline in DLQI >= 4 for
subjects with DLQI >= 4 at Baseline at Week 12. - Achievement of an improvement
(reduction) from Baseline in DLQI >= 4 for subjects with DLQI >= 4 at Baseline at
Week 24. - Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at
Week 12. - Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at
Week 24.
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. This study evaluates the dosing flexibility of
upadacitinib in adult participants with moderate to severe AD. Adverse events
and change in the disease activity will be assessed.
Study objective
This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data.
1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the
efficacy and safety of dose escalation to upadacitinib 30 mg QD in
subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on
upadacitinib 15 mg QD after 12 weeks.
2. Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the
efficacy and safety of dose reduction to upadacitinib 15 mg QD in
subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No
hypothesis testing will be performed in this study.
Study design
Randomized, double-blind, sequential group study
Intervention
The study is comprised of a 12-week double-blind period, followed by a 12-week
single-blind period. Participants will receive upadacitinib oral tablets once
daily for up to 24 weeks.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care (due to study procedures). 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
- 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
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 |
|---|---|
| EU-CTR | CTIS2023-504869-23-00 |
| EudraCT | EUCTR2022-000434-42-NL |
| CCMO | NL81845.028.22 |