Clinical trial NCT02576938: A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.


Eligibility criteria: Inclusion Criteria:

* Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

  1. EASI of 12 or more
  2. Greater than or equal to 10% of body surface area involvement
  3. Diagnosed with AD at least 2 years prior
* Have a history of inadequate clinical response to other eczema treatments

Exclusion Criteria:

* Females who are pregnant or nursing
* Participants who do not agree to use adequate contraception
* Are currently experiencing or have a history of:

  * Skin conditions such as psoriasis or lupus erythematosus
  * Skin disease that requires frequent hospitalizations or intravenous treatment
  * Compromised immunity
* Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
* Currently experiencing or have a history of:

  * Active or latent Tuberculosis or specific immunity disorders and infections
  * Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
  * Human Immunodeficiency Virus (HIV)
  * Hepatitis B, Hepatitis C, or chronic liver disease
* Have received certain types of vaccinations

Primary outcomes:
measure: Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in the EASI at Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in the EASI at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16
timeFrame: Baseline, Week 16
measure: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib
timeFrame: Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc
state: Florida
city: Atlanta
country: United States
facility: Medical Dermatology Specialists
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Icahn School of Medicine
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Fukuoka-shi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sapporo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Takaoka-shi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
citation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.