Overview

A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis

Status:
Active, not recruiting
Trial end date:
2022-02-18
Target enrollment:
0
Participant gender:
All
Summary
This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Incyte Corporation
Criteria
Have participated in Study JAIW (NCT03435081), and meet specific completion requirements
for that study, and do not meet any of the following Exclusions:

- Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction
[MI], unstable angina, unstable arterial hypertension, severe heart failure, or
cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
during a previous baricitinib study that, in the opinion of the investigator, pose an
unacceptable risk to the participant if investigational product continues to be
administered.

- Have a known hypersensitivity to baricitinib or any component of this investigational
product.

- Had investigational product permanently discontinued at any time during a previous
baricitinib study, except for participants who had investigational product
discontinued during originating study because of rescue with an oral systemic AD
therapy (e.g., corticosteroid, cyclosporine, methotrexate).

- Had temporary investigational product interruption continue at the final study visit
of a previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the participant's participation in the study.

- Pregnant or breastfeeding

OR

• Have not participated in a Study JAIW (NCT03435081) and satisfy the following criteria:

Inclusion Criteria:

- Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.

- Have moderate to severe AD, including all of the following:

- EASI score ≥16

- IGA score of ≥3

- 10%- 50% BSA involvement

- Have had inadequate response or intolerance to existing topical (applied to the skin)
medications within 6 months preceding screening.

- Are willing to discontinue certain treatments for eczema (such as systemic and topical
treatments)

- Agree to use emollients daily.

Exclusion Criteria:

- Are currently experiencing or have a history of other concomitant skin conditions
(e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory,
or unstable skin disease that requires frequent hospitalizations and/or intravenous
treatment for skin infections.

- A history of eczema herpeticum within 12 months, and/or a history of 2 or more
episodes of eczema herpeticum in the past.

- Participants who are currently experiencing a skin infection that requires treatment,
or is currently being treated, with topical or systemic antibiotics.

- Have any serious illness that is anticipated to require the use of systemic
corticosteroids or otherwise interfere with study participation or require active
frequent monitoring (e.g., unstable chronic asthma).

- Have been treated with the following therapies:

- monoclonal antibody for less than 5 half-lives before randomization

- received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4
weeks before randomization

- received any parenteral corticosteroid administered by intramuscular or
intravenous injection within 6 weeks of planned randomization or are anticipated
to require parenteral injection of corticosteroids during the study

- have had an intra-articular corticosteroid injection within 6 weeks of planned
randomization

- probenecid at the time of randomization that cannot be discontinued for the
duration of the study

- Have high blood pressure characterized by a repeated systolic blood pressure >160
millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.

- Have had major surgery within the past eight weeks or are planning major surgery
during the study.

- Have experienced any of the following within 12 weeks of screening: myocardial
infarction (MI), unstable ischemic heart disease, stroke, or New York Heart
Association Stage III/IV heart failure.

- Have a history of venous thromboembolic event (VTE), or are considered at high risk
for VTE.

- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
endocrine, hematological, neurological, lymphoproliferative disease or
neuropsychiatric disorders or any other serious and/or unstable illness.

- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection including herpes zoster, tuberculosis.

- Have specific laboratory abnormalities.

- Have received certain treatments that are contraindicated.

- Pregnant or breastfeeding.