Clinical trial NCT02465606: A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
Official title: An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years, inclusive, at the start of the run-in period
* AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
* Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
* History of inadequate response to a \>/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
* EASI score \>/= 14 at screening
* IGA score \>/= 3
* AD involvement of \>/= 10% body surface area
* Pruritus Visual Analog Scale score \>/= 3

Exclusion Criteria:

* Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
* Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
* Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
* Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
* Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
* Other recent infections meeting protocol criteria
* Active tuberculosis requiring treatment within the 12 months prior to Visit 1
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* Known immunodeficiency, including HIV infection
* Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so
* Clinically significant abnormality on screening ECG or laboratory tests
* Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
* History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies
timeFrame: From baseline to week 20
measure: Number of participants with disease rebound following discontinuation of study drug
timeFrame: within 20 weeks
measure: Serum lebrikizumab concentration at Week 12
timeFrame: Week 12
measure: Elimination half-life
timeFrame: Week 4
measure: Number of participants with skin and other organ system infections
timeFrame: From baseline to week 12
measure: Number of participants with injection site reactions
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Encino
country: United States
facility: T. Joseph Raoof Md, Inc.
state: California
city: Granada Hills
country: United States
facility: Allergy and Asthma Relief Experts
state: California
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern California - CRN
state: California
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research; Institue of Michigan P.L.C.
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Warwick
country: United States
facility: Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
state: Rhode Island
city: Cypress
country: United States
facility: Center for Clinical Studies
state: Texas
city: Surrey
country: Canada
facility: Dr. Lorne E. Albrecht Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Skin Care Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: London
country: Canada
facility: Guenther Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials Inc.
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: