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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Lebrikizumab Dose Level 1 Monotherapy | Experimental | 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. |
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| Group 2: Topical Corticosteroid Creams Only | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies | From baseline to week 20 | |
| Number of participants with disease rebound following discontinuation of study drug | within 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| T. Joseph Raoof Md, Inc. | Encino | California | 91436 | United States | ||
| Allergy and Asthma Relief Experts |
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| Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) | Drug | 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. |
|
| Serum lebrikizumab concentration at Week 12 | Week 12 |
| Elimination half-life | Week 4 |
| Number of participants with skin and other organ system infections | From baseline to week 12 |
| Number of participants with injection site reactions | From baseline to week 12 |
| Granada Hills |
| California |
| 91344 |
| United States |
| Allergy and Asthma Associates of Southern California - CRN | Mission Viejo | California | 92691 | United States |
| Forward Clinical Trials | Tampa | Florida | 33624 | United States |
| Dermatology Specialists Research, LLC | Louisville | Kentucky | 40241 | United States |
| Respiratory Medicine Research; Institue of Michigan P.L.C. | Ypsilanti | Michigan | 48197 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI) | Warwick | Rhode Island | 02865 | United States |
| Center for Clinical Studies | Cypress | Texas | 77433 | United States |
| Dr. Lorne E. Albrecht Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Skin Care Centre | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Guenther Research Inc. | London | Ontario | N6A 3H7 | Canada |
| The Centre for Clinical Trials Inc. | Oakville | Ontario | L6J 7W5 | Canada |
| York Dermatology Center | Richmond Hill | Ontario | L4C 9M7 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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