The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of subjects achieving a 75% reduction in Eczema Area Severity Index
(EASI 75) at Week 16
Secondary outcome
1. Percent change from baseline to Week 16 in Worst Pruritus NRS
2. Proportion of subjects achieving EASI 100 from baseline at Week 16
3. Proportion of subjects achieving EASI 90 from baseline at Week 16
4. Percent change from baseline to Week 4 in Worst Pruritus NRS
5. Proportion of subjects achieving EASI 75 from baseline at Week 2
6. Percent change from baseline to Week 1 in Worst Pruritus NRS
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
The objective of this study is to evaluate the efficacy and safety of
upadacitinib versus dupilumab for the treatment of adult subjects with moderate
to severe atopic dermatitis who are candidates for systemic therapy.
Study design
This is a Phase -3, randomized, double-blind, double-dummy, active controlled
multicenter study. The study is comprised of a 35-day screening period, a 24
week double-blind treatment period, and a Follow-up Visit after 12 weeks.
Intervention
Subjects will be randomized in a 1:1 ratio and will receive upadacitinib or
dupilumab and placebo until Week 24 visit:
• Upadacitinib tablets + placebo pre-filled syringe; OR
• Dupilumab + placebo tablet
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 dupilumab 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 most common side effects that
are reported in previous studies with dupilumab are reactions to the skin, and
inflammation of the lining of the eye.
The objective of the study is to evaluate the efficacy of upadacitinib when
compared to the active treatment dupilumab, with both treatments expected to be
well tolerated in adult subjects with moderate to severe AD, indicating 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 18 between 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
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 |
|---|---|
| EudraCT | EUCTR2018-002264-57-NL |
| ClinicalTrials.gov | NCT03738397 |
| CCMO | NL68247.078.19 |