Back to resultsA Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
Sites / Locations
- T. Joseph Raoof Md, Inc.
- Allergy and Asthma Relief Experts
- Allergy and Asthma Associates of Southern California - CRN
- Forward Clinical Trials
- Dermatology Specialists Research, LLC
- Respiratory Medicine Research; Institue of Michigan P.L.C.
- Montefiore Medical Center
- Sadick Research Group
- Oregon Medical Research Center
- Temple University Hospital
- Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
- Center for Clinical Studies
- Dr. Lorne E. Albrecht Inc.
- Skin Care Centre
- Wiseman Dermatology Research Inc.
- Guenther Research Inc.
- The Centre for Clinical Trials Inc.
- York Dermatology Center
- K. Papp Clinical Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: Lebrikizumab Dose Level 1 Monotherapy
Group 2: Topical Corticosteroid Creams Only
Arm Description
During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.
During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies
Number of participants with disease rebound following discontinuation of study drug
Serum lebrikizumab concentration at Week 12
Elimination half-life
Number of participants with skin and other organ system infections
Number of participants with injection site reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02465606
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2015 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Lebrikizumab Dose Level 1 Monotherapy
Arm Type
Experimental
Arm Description
During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.
Arm Title
Group 2: Topical Corticosteroid Creams Only
Arm Type
Active Comparator
Arm Description
During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Intervention Description
Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.
Intervention Type
Drug
Intervention Name(s)
Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
Intervention Description
Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies
Time Frame
From baseline to week 20
Title
Number of participants with disease rebound following discontinuation of study drug
Time Frame
within 20 weeks
Title
Serum lebrikizumab concentration at Week 12
Time Frame
Week 12
Title
Elimination half-life
Time Frame
Week 4
Title
Number of participants with skin and other organ system infections
Time Frame
From baseline to week 12
Title
Number of participants with injection site reactions
Time Frame
From baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
T. Joseph Raoof Md, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Allergy and Asthma Relief Experts
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Allergy and Asthma Associates of Southern California - CRN
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Forward Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Respiratory Medicine Research; Institue of Michigan P.L.C.
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Center for Clinical Studies
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Dr. Lorne E. Albrecht Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Guenther Research Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
The Centre for Clinical Trials Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
York Dermatology Center
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
We'll reach out to this number within 24 hrs