This study has been transitioned to CTIS with ID 2022-502937-24-00 check the CTIS register for the current data. The objective of the study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Proportion of subjects achieving validated IGA scale for Atopic Dermatitis
(vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week
16;
• Proportion of subjects achieving improvement from baseline of at least 75% on
Eczema Area Severity Index (EASI 75) at Week 16.
Secondary outcome
• Proportion of subjects achieving an improvement (reduction) in Worst Pruritus
Numerical Rating Scale (NRS) >=4 from Baseline at Week 16 for subjects with
Worst Pruritus NRS >= 4 at baseline;
• Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16;
• Percent change from Baseline of Worst Pruritus NRS at Week 16;
• Percent change in EASI score from Baseline at Week 16.
• Proportion of subjects achieving an improvement (reduction) in Worst Pruritus
NRS >= 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS >= 4 at
baseline;
• Proportion of subjects achieving EASI 75 at Week 4;
• Proportion of subjects achieving EASI 75 at Week 2;
• Proportion of subjects achieving EASI 90 at Week 4;
• Proportion of subjects achieving EASI 100 at Week 16 for 30 mg;
• Proportion of subjects achieving vIGA-AD of 0 at Week 16 for 30 mg;
• Proportion of subjects achieving an improvement (reduction) in Worst Pruritus
NRS >= 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS >= 4 at
baseline.
Background summary
Evidence suggests that inhibition of Janus kinase (JAK)-mediated pathways may
be a promising approach for the treatment of subjects with moderate to severe
atopic dermatitis (AD). Current treatment paradigms for AD suggest that there
is a need for additional treatment options for patients. More selective JAK
inhibitors may decrease the risk for infection (including viral reactivation)
and/or malignancy that are observed with pan JAK inhibitor or less selective
JAK inhibitors. AbbVie is developing a small molecule inhibitor of JAK,
upadacitinib, that may address the current needs for subjects with AD.
Study objective
This study has been transitioned to CTIS with ID 2022-502937-24-00 check the CTIS register for the current data.
The objective of the study is to assess the efficacy and safety of upadacitinib
combined with topical corticosteroids (TCS) for the treatment of adolescent and
adult subjects with moderate to severe AD who are candidates for systemic
therapy.
Study design
This is a Phase-3, randomized, double-blind, placebo-controlled multicenter
study. The study is comprised of a 35-day screening period, a 16 week
double-blind treatment period, a blinded extension period of up to Week 260,
and a 30-day Follow-up Visit.
Intervention
Subjects will be randomized in a 1:1:1 ratio and will receive concomitant TCS
with either oral daily doses of upadacitinib (dose A or dose B) or matching
placebo. At the end of the 16 week double-blind treatment period, subjects in
the placebo group will be re-randomized in a 1:1 ratio to receive daily oral
doses of upadacitinib (dose A or dose B) during the blinded extension period.
Subjects originally in the upadacitinib dose A or dose B group will continue
their treatment into the blinded extension period up to the week 260 visit.
Study burden and risks
There will be higher burden for subjects participating in this trial compared
to their standard of care. Subject will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling and questionnaires. Subject will also be tested for TB,
significant heart conditions, pregnancy, HCV/HBV and HIV. Subjects will also
complete a daily diary. Women of Childbearing Potential should practice a
method of birth control, during the study through at least 30 days after the
last dose of study drug.
Subjects will either receive upadacitinib or placebo during the study. The most
common side effects reported during previous studies of upadacitinib were
headache, upper chest infection, common cold, diarrhea and cough. An elevation
of an enzyme in the blood called creatine phosphokinase (CPK, a protein
released mainly from muscle cells) was observed in treated patients. The
majority of these patients did not have any muscle symptoms and did not stop
study drug because of elevated CPK levels.
The hypothesis that upadacitinib should be effective in targeting inflammation
associated with AD and the lack of approved systemic therapies for moderate to
severe AD, especially for long-term use, indicate that there is an acceptable
rationale to conduct this study. There may or may not be benefit for study
subjects but there may be benefit for future patients with atopic dermatitis.
The subject*s condition may get better, may worsen, or may stay unchanged.
Wegalaan 9
Hoofddorp 2132JD
NL
Wegalaan 9
Hoofddorp 2132JD
NL
Listed location countries
Age
Inclusion criteria
• Male or female subjects 12-75 years of age , • Active moderate to severe
atopic dermatitis defined by EASI, IGA, BSA, and pruritus, • Candidate for
systemic therapy or have recently required systemic therapy for atopic
dermatitis, • Able to tolerate topical corticosteroids for atopic dermatitis
lesions
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, • 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
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 | CTIS2022-502937-24-00 |
| EudraCT | EUCTR2017-005126-37-NL |
| ClinicalTrials.gov | NCT03568318 |
| CCMO | NL66138.042.18 |