Study of Baricitinib in AdultPatients with Atopic Dermatitis

Phase 3

Active, not recruiting

• Conditions: Health Condition 1: null- Adult Patients with Atopic DermatitisHealth Condition 2: L209- Atopic dermatitis, unspecified

• Registration Number: CTRI/2018/02/011972
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

[1] Have completed the final active treatment visit for an originating study (i.e.,

Visit 8, Week 16 of JAHL or JAHM) eligible to enroll patients directly into

Study JAHN.

[2] Are able to read, understand, and give documented (electronic or paper

signature) informed consent.

[3] Are male or nonpregnant, nonbreastfeeding female patients, except

a. Male patients must agree to use 2 forms of birth control (one must be

highly effective, see below) while engaging in sexual intercourse with

female partners of childbearing potential while enrolled in the study and

for at least 4 weeks following the last dose of IP.

b. Female patients of childbearing potential must agree to use 2 forms of

birth control when engaging in sexual intercourse with a male partner

while enrolled in the study and for at least 4 weeks following the last

dose of IP.

The following birth control methods are considered acceptable (the patient should choose

2 methods to be used with her male partner, and 1 must be highly effective):

o Highly effective birth control methods: oral, injectable, or implanted

hormonal contraceptives (combined estrogen/progesterone or

progesterone only, associated with inhibition of ovulation);

intrauterine device or intrauterine system (e.g., progestin-releasing

coil); or vasectomized male (with appropriate post-vasectomy

documentation of the absence of sperm in the ejaculate)

o Effective birth control methods: condom with a spermicidal foam,

gel, film, cream, or suppository; occlusive cap (diaphragm or

cervical/vault caps) with a spermicidal foam, gel, film, cream, or

suppository; or oral hormonal contraceptives

c. Females of nonchildbearing potential are not required to use birth

control and they are defined as:

o women �60 years of age or women who are congenitally sterile, or

o women �40 and <60 years of age who have had a cessation of

menses for �12 months and a follicle-stimulating hormone test from

baseline in originating study, confirming nonchildbearing potential

(�40 mIU/mL or �40 IU/L), or

o women who are surgically sterile (i.e., have had a hysterectomy or

bilateral oophorectomy or tubal ligation).

Exclusion Criteria

[1] Are currently enrolled in any other clinical trial involving an IP or any other

type of medical research judged not to be scientifically or medically

compatible with this study.

[2] 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 patient

if IP continues to be administered.

[3] Have a known hypersensitivity to baricitinib or any component of this IP.

[4] Had IP permanently discontinued at any time during a previous baricitinib

study, except for patients who had IP discontinued during originating study

due to rescue with an oral systemic AD therapy (e.g., corticosteroid,

cyclosporine, methotrexate)

[5] Had temporary IP 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 patientââ?¬•s participation in the study.

[6] Have any other condition that, in the opinion of the investigator, renders the

patient unable to understand the nature, scope, and possible consequences of

the study or precludes the patient from following and completing the protocol.

[7] Are unwilling or unable to comply with the use of a data collection device to

directly record data from the subject.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the effect of long-term therapy with baricitinib <br/ ><br>on responders and partial responders at entry of JAHNTimepoint: Proportion of patients with a response of IGA 0 or 1 <br/ ><br>assessed at Weeks 16, 36, and 52