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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGCD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis.
This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab | Experimental | Lebrikizumab administered subcutaneously (SC). |
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| Placebo | Placebo Comparator | Placebo Administered SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline | The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline | The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch). | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology Research Inc | Fountain Valley | California | 92708 | United States | ||
| Dermatology Research Associates |
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| Label | URL |
|---|---|
| Lilly Trials | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline | The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch). | Week 2 |
| Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline | The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch). | Baseline, Week 4 |
| Percentage of Participants with a HF-Peak Pain NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline | The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible). | Week 16 |
| Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline | The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity. | Week 4 |
| Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline | The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity. | Week 8 |
| Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS) | This single-item question assesses participants' satisfaction with hand clearance at the current time. The response options are reported as the percentage of participants who selected 1 of the following: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, or Very Dissatisfied. | Week 16 |
| Percent Change from Baseline in Hand and Foot Peak Pain NRS | The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible). | Baseline, Week 16 |
| Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions | The mTLSS is an investigator-reported scale that combines the evaluation of lesion severity of hand eczema (HE) (erythema, edema, desquamation, fissures, hyperkeratosis or lichenification, and vesicles) with the intensity of pruritus or pain to assess the severity of symptoms. This composite score assigns 0 (mild) to 3 (severe) to each component, giving a maximum disease severity of 21. A separate score is assigned for hands and feet. | Baseline, Week 16 |
| Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score | The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points. | Week 16 |
| Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis | The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points. | Baseline, Week 16 |
| Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score | The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points. | Week 16 |
| Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score | The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points. | Week 16 |
| Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis | The QOLHEQ consists of 30 items that can be summarized according to 4 domains of HRQoL: impairments over the last 7 days because of (1) symptoms, (2) emotions, (3) limitations in functioning, or (4) treatment and prevention. The total QOLHEQ score ranges between 0 and 117, with higher scores indicative of a poor HE-specific HRQoL. | Baseline, Week 16 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| Research Associates of South Florida - Miami - Southwest 8th Street | Miami | Florida | 33134 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| DeNova Research | Chicago | Illinois | 60602 | United States |
| Southern Indiana Clinical Trials | New Albany | Indiana | 47150 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Care Access - Hoboken | Hoboken | New Jersey | 07030 | United States |
| Optima Research - Boardman | Boardman | Ohio | 44512 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Complete Dermatology | Sugar Land | Texas | 77479 | United States |
| CONEXA Investigacion Clinica S.A. | Buenos Aires | 1012 | Argentina |
| Investigaciones Medicas Imoba Srl | Buenos Aires | C1056ABH | Argentina |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| Instituto de Neumonologia Y Dermatologia | Buenos Aires | C1425BEA | Argentina |
| Psoriahue | Buenos Aires | C1425DKG | Argentina |
| Fundación Respirar | Buenos Aires | C1426ABP | Argentina |
| Parra Dermatología | Mendoza | 5500 | Argentina |
| Fundacion Estudios Clinicos | Rosario | 2000 | Argentina |
| INECO Neurociencias Oroño | Rosario | 2000 | Argentina |
| Instituto de Investigaciones Clinicas Rosario | Rosario | S2000CVD | Argentina |
| Centro de Investigaciones San Miguel | San Miguel | 1663 | Argentina |
| The Skin Centre | Benowa | 4217 | Australia |
| Skin Health Institute Inc. | Carlton | 3053 | Australia |
| Cornerstone Dermatology | Coorparoo | 4151 | Australia |
| Fremantle Dermatology | Fremantle | 6160 | Australia |
| St George Dermatology & Skin Cancer Centre | Kogarah | 2217 | Australia |
| Institute for Skin, Health and Immunity | Mitcham | 3132 | Australia |
| Paratus Clinical Research Woden | Phillip | 2606 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | L4M 7G1 | Canada |
| INTERMED Groupe Sante | Chicoutimi | G7H 7Y8 | Canada |
| Interior Dermatology Centre - Probity - PPDS | Kelowna | V1W 4V5 | Canada |
| DermEffects | London | N6H 5L5 | Canada |
| Centre de Recherche Saint-Louis | Montreal | H1Y 3L1 | Canada |
| Centre de Recherche Saint-Louis | Québec | G1W 4R4 | Canada |
| CaRe Clinic | Red Deer | T4P 1K4 | Canada |
| Private Practice - Dr. Rachel Asiniwasis | Regina | S4V 1R9 | Canada |
| FACET Dermatology | Toronto | M4E 1R7 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | R3M 3Z4 | Canada |
| Kosugi Dermatology Clinic | Kawasaki-shi | 211-0063 | Japan |
| Maruyama Dermatology Clinic | Kōtoku | 136-0074 | Japan |
| University Hospital,Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Tanpopo Skin Clinic | Ōta-ku | 143-0023 | Japan |
| Pansy Skin Clinic | Saitama | 330-0064 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai | 593-8324 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | 160-0023 | Japan |
| Tachikawa Dermatology Clinic | Tachikawa | 190-0023 | Japan |
| Scientia Investigacion Clinica S.C. | Chihuahua City | 31203 | Mexico |
| Cryptex Investigación Clínica S.A. de C.V. | Cuauhtémoc, Ciudad de México | 06100 | Mexico |
| Kohler & Milstein Research S.A. De C.V. | Mérida | 97070 | Mexico |
| Eukarya Pharmasite S.C. | Monterrey | 64718 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91900 | Mexico |
| Korea University Ansan Hospital | Ansan-si | 15355 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Bupyeong-gu | 21431 | South Korea |
| Pusan National University Yangsan Hospital | Busan | 50612 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Kyungpook National University Hospital | Junggu | 41944 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
| New Taipei Municipal TuCheng Hospital | New Taipei City | 236 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| National Taiwan University Hospital - Hsinchu branch | Zhubei | 302 | Taiwan |
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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