A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
- Conditions
- Atopic Hand and Foot Dermatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06921759
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 206
- Have an unequivocal diagnosis of chronic atopic hand and/or foot dermatitis at least 1 year prior to screening, regardless of the extent and severity of concomitant atopic dermatitis (AD) on other areas of the body. AD must be present in at least 2 of the 4 mentioned anatomical areas: left hand, right hand, left foot, or right foot at screening and baseline.
- Have a Hand Foot - Investigator Global Assessment (HF-IGA) score of 3 or 4 at the screening and baseline visits.
- Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4.
- Have a documented history by the investigator of inadequate response to topical corticosteroids (TCS) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of TCS is medically inadvisable (due to intolerance to treatment, hypersensitivity reactions, significant skin atrophy of hand and feet, and systemic effects, as assessed by the investigator or by the treating physician of the participant).
- For adolescent participants, body weight ≥40 kilograms (kg) at baseline.
- Have a positive patch test reaction to 1 or more allergens (a score of 1+ or above according to the International Contact Dermatitis Research Group grading scale) before baseline AND which are deemed to be clinically relevant in the view of the investigator as the current cause of the hand and foot dermatitis.
- Have a documented diagnosis of allergic contact dermatitis (ACD) of hands and/or feet, and have a positive patch test reaction at screening, regardless of whether the history of current skin exposure to products containing this allergen (current relevance) is present.
- Have a documented or strong clinical suspicion of the diagnosis of protein contact dermatitis of hands and/or feet. These are the participants with occupational or nonoccupational contact with proteins such as food, latex, and so on, who have positive prick test results and present with lesions of contact urticaria or dermatitis on hands and feet.
- Have a documented exposure to irritants in the occupational or non-occupational (household/recreational) setting that is believed to be a predominant cause of the current hand and foot dermatitis as per the judgment of the investigator.
- Presence of skin comorbidities on hand and/or foot that may interfere with study assessments, such as (but not limited to) palmoplantar psoriasis, palmoplantar keratoderma, impetiginized eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies.
- Have skin comorbidities that may interfere with study assessments
- Treatment with topical medications within 2 weeks before the baseline visit (except for the use of the participant's own emollients).
- Prior treatment with interleukin-13 (IL-13) inhibitors such as lebrikizumab or tralokinumab.
- Have received any live attenuated vaccine within less than 4 weeks of the baseline visit or intend to receive a live attenuated vaccine during the study, or within 4 weeks after receiving the last dose of study intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab Lebrikizumab Lebrikizumab administered subcutaneously (SC). Placebo Placebo Placebo Administered SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score Week 16 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.
Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS) Week 16 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.
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 Week 16 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).
Percent Change from Baseline in Hand and Foot Peak Pain NRS Baseline, Week 16 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).
Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline Baseline, Week 4 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).
Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions Baseline, Week 16 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.
Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis Baseline, Week 16 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.
Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score Week 16 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.
Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score Week 16 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.
Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis Baseline, Week 16 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.
Related Research Topics
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Trial Locations
- Locations (82)
Pansy Skin Clinic
🇯🇵Saitama, Japan
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Bupyeong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan-si, Kyǒnggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Kyǒnggi-do, Korea, Republic of
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
First OC Dermatology Research Inc
🇺🇸Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Research Associates of South Florida - Miami - Southwest 8th Street
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
DeNova Research
🇺🇸Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Care Access - Hoboken
🇺🇸Hoboken, New Jersey, United States
Optima Research - Boardman
🇺🇸Boardman, Ohio, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Instituto de Neumonologia Y Dermatologia
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Psoriahue
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fundación Respirar
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro de Investigaciones San Miguel
🇦🇷San Miguel, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
CONEXA Investigacion Clinica S.A.
🇦🇷Buenos Aires, Argentina
CIPREC
🇦🇷Buenos Aires, Argentina
Parra Dermatología
🇦🇷Mendoza, Argentina
Paratus Clinical Research Woden
🇦🇺Phillip, Australian Capital Territory, Australia
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
St George Dermatology & Skin Cancer Centre
🇦🇺Kogarah, New South Wales, Australia
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Cornerstone Dermatology
🇦🇺Coorparoo, Queensland, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Skin Health Institute Inc.
🇦🇺Carlton, Victoria, Australia
Institute for Skin, Health and Immunity
🇦🇺Mitcham, Victoria, Australia
Fremantle Dermatology
🇦🇺Fremantle, Western Australia, Australia
Brecken Health Bunbury
🇦🇺South Bunbury, Western Australia, Australia
CaRe Clinic
🇨🇦Red Deer, Alberta, Canada
Interior Dermatology Centre - Probity - PPDS
🇨🇦Kelowna, British Columbia, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
DermEffects
🇨🇦London, Ontario, Canada
FACET Dermatology
🇨🇦Toronto, Ontario, Canada
INTERMED Groupe Sante
🇨🇦Chicoutimi, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada
Private Practice - Dr. Rachel Asiniwasis
🇨🇦Regina, Saskatchewan, Canada
Kosugi Dermatology Clinic
🇯🇵Kawasaki-shi, Kanagawa, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai City, Osaka, Japan
Maruyama Dermatology Clinic
🇯🇵Koto-ku, Tokyo, Japan
Tanpopo Skin Clinic
🇯🇵Ota, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tachikawa Dermatology Clinic
🇯🇵Tachikawa, Tokyo, Japan
University Hospital,Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Pusan National University Yangsan Hospital
🇰🇷Busan, Kyǒngsangnam-do, Korea, Republic of
National Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Hospital
🇰🇷Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of
Cryptex Investigación Clínica S.A. de C.V.
🇲🇽Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Grupo Clínico CATEI S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Instituto Dermatologico de Jalisco
🇲🇽Zapopan, Jalisco, Mexico
Eukarya Pharmasite S.C.
🇲🇽Monterrey, Nuevo León, Mexico
Kohler & Milstein Research S.A. De C.V.
🇲🇽Mérida, Yucatán, Mexico
Scientia Investigacion Clinica S.C.
🇲🇽Chihuahua, Mexico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
National Taiwan University Hospital - Hsinchu branch
🇨🇳Zhu Bei City, Hsinchu, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
New Taipei Municipal TuCheng Hospital
🇨🇳New Taipei City, New Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei City, Taipei, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan