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A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02465606
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Lebrikizumab Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2015
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : May 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
Experimental: Group 1: Lebrikizumab Dose Level 1 Monotherapy
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.
Drug: Lebrikizumab
Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
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.

Active Comparator: Group 2: Topical Corticosteroid Creams Only
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.
Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
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 Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline to week 12 ]

Secondary Outcome Measures :
  1. Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies [ Time Frame: From baseline to week 20 ]
  2. Number of participants with disease rebound following discontinuation of study drug [ Time Frame: within 20 weeks ]
  3. Serum lebrikizumab concentration at Week 12 [ Time Frame: Week 12 ]
  4. Elimination half-life [ Time Frame: Week 4 ]
  5. Number of participants with skin and other organ system infections [ Time Frame: From baseline to week 12 ]
  6. Number of participants with injection site reactions [ Time Frame: From baseline to week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465606


Locations
Show Show 19 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02465606    
Other Study ID Numbers: GS29735
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Antibodies, Monoclonal
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action