Clinical Trials List
Protocol NumberJ2T-MC-KGCD
NCT Number(ClinicalTrials.gov Identfier)NCT06921759
Active
2025-06-30 - 2027-07-28
Phase III
Recruiting7
ICD-10L20.0
Besnier's prurigo
ICD-10L20.81
Atopic neurodermatitis
ICD-10L20.82
Flexural eczema
ICD-10L20.83
Infantile (acute) (chronic) eczema
ICD-10L20.84
Intrinsic (allergic) eczema
ICD-10L20.89
Other atopic dermatitis
ICD-10L20.9
Atopic dermatitis, unspecified
ICD-9691.8
Other atopic dermatitis and related conditions
A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy and safety of lebrikizumab in adult and adolescent participants with moderate to severe atopic dermatitis of the hands and feet.
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly Taiwan
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/24
Investigators and Locations
Co-Principal Investigator
- 黃瑞雲 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉威廷 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Chan 無
- 卓雍哲 無
- WEI-HSIN WU 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yun-Ting Chang 無
- DINGDAR LEE 無
- 吳貞宜 無
- Cheng-Yuan Li 無
- 何翊芯 無
- 馬聖翔 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ya-Ching Chang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Moderate to severe atopic dermatitis of the hands and feet
Objectives
Learn more about Lebrikizumab, a potential new drug for treating atopic dermatitis of the hands and feet (AHFD).
This trial aims to understand:
1. Whether Lebrikizumab can relieve atopic dermatitis of the hands and/or feet
2. Whether Lebrikizumab is more effective than a placebo (a placebo is an inactive or "disguised" experimental drug)
3. What are the possible side effects?
Test Drug
EBGLYSS Injection
Active Ingredient
D11AH10000
Dosage Form
Prefilled Injectable
Dosage
001
Endpoints
• The proportion of participants who achieved a Hand and Foot Trial Attorney Overall Assessment (HF-IGA) score of 0 or 1 and showed an improvement of ≥ 2 points from the baseline to week 16.
Inclution Criteria
Key Inclusion Criteria
Participants must meet all of the following applicable criteria to be included in the trial:
Age
1. Must be ≥ 12 years old at the time of signing the participant consent form or the minor participant consent form.
Participant Type and Disease Characteristics
2. A confirmed diagnosis of chronic atopic dermatitis of the hands and/or feet for at least one year prior to screening, regardless of the extent and severity of AD in other areas of the body. AD must occur in at least two of the following four anatomical regions at screening and baseline: left hand, right hand, left foot, or right foot.
3. Meet the Hanifin and Rajka criteria for diagnosing AD, or have a recorded history of AD.
Note: The diagnosis of AD must meet at least three of the four major criteria and at least three of the 23 minor criteria.
4. Hand and foot investigator-wide assessment (HF-IGA) scores of 3 or 4 at screening and baseline follow-up visits.
Note: The investigator should assign a single investigator-wide assessment (IGA) score based on their overall impression of the severity of the hand and foot disease. To be eligible, you must have moderate to severe hand/foot disease overall, involving at least two of the four anatomical regions listed in inclusion criterion 2.
5. Your baseline Numerical Rating Scale (NRS) score for the most severe pruritus in your hands and feet must be greater than or equal to 4.
Note: You must have completed an electronic pruritus log for at least four days within the week prior to randomization (excluding the day of randomization). The baseline score is calculated based on the average of the log entries completed during these seven days.
6. Assessment of poor response to topical corticosteroid (TCS) treatment: If, within the six months prior to screening, the trial administrator deems your response to topical corticosteroids (TCS) inadequate, or if you do not recommend continued use of TCS for medical reasons (e.g., adverse reactions, allergies, severe atrophy of the skin on the hands and feet, or other systemic side effects), this will be recorded.
a. If the above records are insufficient, you may receive at least 28 days of daily intermediate- or high-potency TCS treatment during the trial screening period (whether combined with a topical calcineurin inhibitor (TCI) will be determined by the trial administrator), or the longest duration recommended on the drug's package insert (whichever is shorter).
b. If you still do not achieve a adequate treatment response (defined below) during this duration, you may be eligible for this trial after appropriate discontinuation of the medication (see Exclusion Criterion 30).
Note: o Poor response is defined as: even if you have received at least 28 days of continuous daily intermediate- or high-potency TCS treatment (whether combined with a TCI depends on the situation), or the longest duration recommended on the package insert (e.g., up to 14 days for ultra-high-potency TCS), you still have not achieved or maintained remission, or your disease activity remains high, as assessed by your attending physician's clinical judgment.
o Acceptable medical records include: prescription records for topical treatment, efficacy assessments, or relevant records recorded after discussions between the trial administrator and your attending physician.
If you have used systemic treatments (e.g., cyclosporine, methotrexate, systemic corticosteroids, alitretinoin, etc.) within the past 6 months, this may also be considered a poor response to local treatment. You may still be eligible for trial inclusion after an appropriate withdrawal period.
Weight
7. For adolescent participants, a baseline weight ≥ 40 kg is required.
Sex Determined at Birth and Contraception/Barrier Requirements
8. Individuals identified as male at birth (AMAB) and female at birth (AFAB) are eligible to participate in this trial.
Participants should use contraceptive methods that comply with local regulations regarding contraceptive use for clinical trial participants.
Informed Consent
9. For adult participants: Able to sign informed consent as described in the trial protocol, including following the Intended Participant Consent Form (ICF) and the requirements and restrictions listed in this trial protocol.
10. For adolescent participants: Parents or legal guardians must be able to read, understand, and provide written informed consent in accordance with local regulations for adolescent participation in this trial.
Note: Adult adolescents must provide consent to continue participating in the trial during the trial period.
Other Inclusion Criteria
11. Willingness and ability to comply with all clinical follow-up visits and trial-related procedures and complete the questionnaire.
Participants must meet all of the following applicable criteria to be included in the trial:
Age
1. Must be ≥ 12 years old at the time of signing the participant consent form or the minor participant consent form.
Participant Type and Disease Characteristics
2. A confirmed diagnosis of chronic atopic dermatitis of the hands and/or feet for at least one year prior to screening, regardless of the extent and severity of AD in other areas of the body. AD must occur in at least two of the following four anatomical regions at screening and baseline: left hand, right hand, left foot, or right foot.
3. Meet the Hanifin and Rajka criteria for diagnosing AD, or have a recorded history of AD.
Note: The diagnosis of AD must meet at least three of the four major criteria and at least three of the 23 minor criteria.
4. Hand and foot investigator-wide assessment (HF-IGA) scores of 3 or 4 at screening and baseline follow-up visits.
Note: The investigator should assign a single investigator-wide assessment (IGA) score based on their overall impression of the severity of the hand and foot disease. To be eligible, you must have moderate to severe hand/foot disease overall, involving at least two of the four anatomical regions listed in inclusion criterion 2.
5. Your baseline Numerical Rating Scale (NRS) score for the most severe pruritus in your hands and feet must be greater than or equal to 4.
Note: You must have completed an electronic pruritus log for at least four days within the week prior to randomization (excluding the day of randomization). The baseline score is calculated based on the average of the log entries completed during these seven days.
6. Assessment of poor response to topical corticosteroid (TCS) treatment: If, within the six months prior to screening, the trial administrator deems your response to topical corticosteroids (TCS) inadequate, or if you do not recommend continued use of TCS for medical reasons (e.g., adverse reactions, allergies, severe atrophy of the skin on the hands and feet, or other systemic side effects), this will be recorded.
a. If the above records are insufficient, you may receive at least 28 days of daily intermediate- or high-potency TCS treatment during the trial screening period (whether combined with a topical calcineurin inhibitor (TCI) will be determined by the trial administrator), or the longest duration recommended on the drug's package insert (whichever is shorter).
b. If you still do not achieve a adequate treatment response (defined below) during this duration, you may be eligible for this trial after appropriate discontinuation of the medication (see Exclusion Criterion 30).
Note: o Poor response is defined as: even if you have received at least 28 days of continuous daily intermediate- or high-potency TCS treatment (whether combined with a TCI depends on the situation), or the longest duration recommended on the package insert (e.g., up to 14 days for ultra-high-potency TCS), you still have not achieved or maintained remission, or your disease activity remains high, as assessed by your attending physician's clinical judgment.
o Acceptable medical records include: prescription records for topical treatment, efficacy assessments, or relevant records recorded after discussions between the trial administrator and your attending physician.
If you have used systemic treatments (e.g., cyclosporine, methotrexate, systemic corticosteroids, alitretinoin, etc.) within the past 6 months, this may also be considered a poor response to local treatment. You may still be eligible for trial inclusion after an appropriate withdrawal period.
Weight
7. For adolescent participants, a baseline weight ≥ 40 kg is required.
Sex Determined at Birth and Contraception/Barrier Requirements
8. Individuals identified as male at birth (AMAB) and female at birth (AFAB) are eligible to participate in this trial.
Participants should use contraceptive methods that comply with local regulations regarding contraceptive use for clinical trial participants.
Informed Consent
9. For adult participants: Able to sign informed consent as described in the trial protocol, including following the Intended Participant Consent Form (ICF) and the requirements and restrictions listed in this trial protocol.
10. For adolescent participants: Parents or legal guardians must be able to read, understand, and provide written informed consent in accordance with local regulations for adolescent participation in this trial.
Note: Adult adolescents must provide consent to continue participating in the trial during the trial period.
Other Inclusion Criteria
11. Willingness and ability to comply with all clinical follow-up visits and trial-related procedures and complete the questionnaire.
Exclusion Criteria
Key Exclusion Criteria
Participants will be excluded from this trial if they meet any of the following criteria:
Medical Conditions
12. At the first follow-up visit before the baseline period, the participant must have a positive patch test for one or more allergens (ICDRG classification score of 1+ or higher), and the trial administrator must believe that these allergens are associated with hand and foot dermatitis.
13. At screening, the participant has a history of diagnosis for allergic contact dermatitis (ACD) of the hands and/or feet, and a positive patch test, regardless of whether the skin has been in contact with products containing the allergen.
14. A history of diagnosis for protein contact dermatitis of the hands and/or feet, or a strong clinical suspicion of having this condition. These participants have had occupational or non-occupational exposure to proteins (e.g., food, latex, etc.), a positive skin prick test, and contact urticaria or dermatitis lesions on the hands and feet.
15. A history of exposure to irritants in occupational or non-occupational (home/leisure) settings, deemed by the trial administrator to be a significant cause of the current hand and foot dermatitis. A detailed history of irritant exposure in both occupational and non-occupational settings will be inquired about during screening.
Note:
• Participants with AHFD may have identified irritants known to worsen their condition. Based on the clinical history and at the trial administrator's discretion, participants may still be included in the trial if:
o The identified irritant is not a primary or significant cause of their symptoms, and
o The participant is willing and able to avoid these irritants throughout the trial.
• Participants may also be excluded based on the trial administrator's clinical judgment if their hand and foot dermatitis is primarily caused by irritant contact dermatitis resulting from wet work in home or occupational settings. The trial administrator may use the wet work criteria established by Behroozy and Keegel (2014) as a guideline:
o During each work shift, the worker must immerse their hands in liquid for more than 2 hours,
o Or wear waterproof gloves during this time,
or wash their hands more than 20 times per work shift. 16. Presence of comorbid hand and/or foot conditions that may interfere with test evaluation, such as (but not limited to) palmoplantar tinea, palmoplantar keratosis, pustular eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies.
17. History of HIV infection or HIV serological positivity at screening.
18. Current or chronic infection with hepatitis B virus (HBV) at screening, meaning positive for hepatitis B surface antigen (HBsAg) and/or positive for HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR).
19. Current infection with hepatitis C virus (HCV) at screening, meaning positive for HCV ribonucleic acid (RNA).
20. Uncontrolled chronic disease that may require intermittent, multiple doses of oral or systemic corticosteroids at screening (as defined by the trial administrator).
21. Known cirrhosis or chronic hepatitis of any etiology.
22. History of malignancy within the 5 years prior to screening (including mycosis fungoides or cutaneous T-cell lymphoma), except for fully treated cervical carcinoma in situ or fully treated and remission non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
23. Diagnosis of active parasitic infection or high risk for such infection.
24. Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary sporidiosis, and aspergillosis). (Even though the infection has healed); or infections deemed unusually frequent, recurrent, or persistent by the trial administrator.
25. Having a comorbid skin condition that may interfere with trial evaluation.
26. Having a serious comorbidity that the trial administrator deems may negatively impact a participant's participation in the trial.
27. Having any other medical or psychiatric condition that the trial administrator believes may pose an unreasonable risk to the participant, as participation in this clinical trial may interfere with trial evaluation.
28. Having any of the following types of infection within the 3 months prior to screening, or any of these infections occurring during screening:
• Severe infection (requiring hospitalization, intravenous or equivalent oral antibiotic treatment)
• Opportunistic infection
Note: Herpes zoster is considered active and ongoing until all blisters have dried and crusted over.
• Chronic infection (symptoms, signs, or treatment lasting 8 weeks or longer), or
• Recurrent infection (including, but not limited to, recurrent cellulitis, chronic osteomyelitis)
Note: Participants with only recurrent, mild, and uncomplicated oral or genital herpes may discuss with the trial sponsor's medical monitor to determine if the participant meets this exclusion criterion.
29. Having an active or acute infection requiring treatment with systemic or topical antibiotics, antiviral agents, antiparasitic agents, antiprotozoal agents, or antifungal agents within 2 weeks prior to the baseline return visit (baseline; second return visit), or a superficial skin infection within 1 week prior to the baseline return visit.
Note:
• Participants may be screened again after infection resolution.
• Subjects with upper respiratory tract infections, vaginal candidiasis, or oral candidiasis who meet other eligibility criteria for the trial and require only symptomatic treatment without systemic anti-infective therapy may be considered for inclusion. The inclusion of participants with other simple local infections should be discussed with the medical monitor.
Previous/Concomitant Treatment
30. Using topical medications (excluding self-administered moisturizers) within 2 weeks prior to the baseline return visit.
31. Previous treatment with an IL-13 inhibitor, such as lebrikizumab or tralokinumab.
32. Treatment with any of the following medications known to affect AD within 4 weeks prior to the baseline return visit:
a. Systemic immunosuppressive/immunomodulatory drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma, azathioprine, methotrexate, and other immunosuppressants)
b. Small molecule drugs (e.g., JAK inhibitors)
c. Phototherapy and photochemotherapy, and
d. dupilumab.
33. Treatment with any of the following medications known to affect AD prior to the baseline return visit:
a. Nemolizumab within 16 weeks
b. B-cell-depleting biologics (including rituximab) within 6 months, or
c. Other biologics within 5 half-lives (if known) or 16 weeks (whichever is longer).
34. Received any live attenuated vaccine within 4 weeks prior to the baseline return visit, or intend to receive a live attenuated vaccine during the trial or within 4 weeks after receiving the last dose of the experimental intervention.
35. Used cannabis or cannabinoids to treat itching, pain, and Alzheimer's disease (AD).
36. Plans or anticipates using any prohibited drugs or procedures during the trial treatment.
Previous/Concurrent Clinical Trial Experience
37. Currently enrolled in any other clinical trial involving the investigational drug, or any other type of medical research deemed scientifically or medically incompatible with this trial.
38. Used the investigational drug within 8 weeks prior to the baseline return visit or within 5 half-lives (if known), whichever is longer.
Other Exclusions
39. Currently pregnant or breastfeeding, or planning to become pregnant or breastfeed during the trial.
40. Known allergy to any component of lebrikizumab.
41. Participant or caregiver unwilling to receive subcutaneous (SC) injection of the investigational drug.
Participants will be excluded from this trial if they meet any of the following criteria:
Medical Conditions
12. At the first follow-up visit before the baseline period, the participant must have a positive patch test for one or more allergens (ICDRG classification score of 1+ or higher), and the trial administrator must believe that these allergens are associated with hand and foot dermatitis.
13. At screening, the participant has a history of diagnosis for allergic contact dermatitis (ACD) of the hands and/or feet, and a positive patch test, regardless of whether the skin has been in contact with products containing the allergen.
14. A history of diagnosis for protein contact dermatitis of the hands and/or feet, or a strong clinical suspicion of having this condition. These participants have had occupational or non-occupational exposure to proteins (e.g., food, latex, etc.), a positive skin prick test, and contact urticaria or dermatitis lesions on the hands and feet.
15. A history of exposure to irritants in occupational or non-occupational (home/leisure) settings, deemed by the trial administrator to be a significant cause of the current hand and foot dermatitis. A detailed history of irritant exposure in both occupational and non-occupational settings will be inquired about during screening.
Note:
• Participants with AHFD may have identified irritants known to worsen their condition. Based on the clinical history and at the trial administrator's discretion, participants may still be included in the trial if:
o The identified irritant is not a primary or significant cause of their symptoms, and
o The participant is willing and able to avoid these irritants throughout the trial.
• Participants may also be excluded based on the trial administrator's clinical judgment if their hand and foot dermatitis is primarily caused by irritant contact dermatitis resulting from wet work in home or occupational settings. The trial administrator may use the wet work criteria established by Behroozy and Keegel (2014) as a guideline:
o During each work shift, the worker must immerse their hands in liquid for more than 2 hours,
o Or wear waterproof gloves during this time,
or wash their hands more than 20 times per work shift. 16. Presence of comorbid hand and/or foot conditions that may interfere with test evaluation, such as (but not limited to) palmoplantar tinea, palmoplantar keratosis, pustular eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies.
17. History of HIV infection or HIV serological positivity at screening.
18. Current or chronic infection with hepatitis B virus (HBV) at screening, meaning positive for hepatitis B surface antigen (HBsAg) and/or positive for HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR).
19. Current infection with hepatitis C virus (HCV) at screening, meaning positive for HCV ribonucleic acid (RNA).
20. Uncontrolled chronic disease that may require intermittent, multiple doses of oral or systemic corticosteroids at screening (as defined by the trial administrator).
21. Known cirrhosis or chronic hepatitis of any etiology.
22. History of malignancy within the 5 years prior to screening (including mycosis fungoides or cutaneous T-cell lymphoma), except for fully treated cervical carcinoma in situ or fully treated and remission non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
23. Diagnosis of active parasitic infection or high risk for such infection.
24. Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary sporidiosis, and aspergillosis). (Even though the infection has healed); or infections deemed unusually frequent, recurrent, or persistent by the trial administrator.
25. Having a comorbid skin condition that may interfere with trial evaluation.
26. Having a serious comorbidity that the trial administrator deems may negatively impact a participant's participation in the trial.
27. Having any other medical or psychiatric condition that the trial administrator believes may pose an unreasonable risk to the participant, as participation in this clinical trial may interfere with trial evaluation.
28. Having any of the following types of infection within the 3 months prior to screening, or any of these infections occurring during screening:
• Severe infection (requiring hospitalization, intravenous or equivalent oral antibiotic treatment)
• Opportunistic infection
Note: Herpes zoster is considered active and ongoing until all blisters have dried and crusted over.
• Chronic infection (symptoms, signs, or treatment lasting 8 weeks or longer), or
• Recurrent infection (including, but not limited to, recurrent cellulitis, chronic osteomyelitis)
Note: Participants with only recurrent, mild, and uncomplicated oral or genital herpes may discuss with the trial sponsor's medical monitor to determine if the participant meets this exclusion criterion.
29. Having an active or acute infection requiring treatment with systemic or topical antibiotics, antiviral agents, antiparasitic agents, antiprotozoal agents, or antifungal agents within 2 weeks prior to the baseline return visit (baseline; second return visit), or a superficial skin infection within 1 week prior to the baseline return visit.
Note:
• Participants may be screened again after infection resolution.
• Subjects with upper respiratory tract infections, vaginal candidiasis, or oral candidiasis who meet other eligibility criteria for the trial and require only symptomatic treatment without systemic anti-infective therapy may be considered for inclusion. The inclusion of participants with other simple local infections should be discussed with the medical monitor.
Previous/Concomitant Treatment
30. Using topical medications (excluding self-administered moisturizers) within 2 weeks prior to the baseline return visit.
31. Previous treatment with an IL-13 inhibitor, such as lebrikizumab or tralokinumab.
32. Treatment with any of the following medications known to affect AD within 4 weeks prior to the baseline return visit:
a. Systemic immunosuppressive/immunomodulatory drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma, azathioprine, methotrexate, and other immunosuppressants)
b. Small molecule drugs (e.g., JAK inhibitors)
c. Phototherapy and photochemotherapy, and
d. dupilumab.
33. Treatment with any of the following medications known to affect AD prior to the baseline return visit:
a. Nemolizumab within 16 weeks
b. B-cell-depleting biologics (including rituximab) within 6 months, or
c. Other biologics within 5 half-lives (if known) or 16 weeks (whichever is longer).
34. Received any live attenuated vaccine within 4 weeks prior to the baseline return visit, or intend to receive a live attenuated vaccine during the trial or within 4 weeks after receiving the last dose of the experimental intervention.
35. Used cannabis or cannabinoids to treat itching, pain, and Alzheimer's disease (AD).
36. Plans or anticipates using any prohibited drugs or procedures during the trial treatment.
Previous/Concurrent Clinical Trial Experience
37. Currently enrolled in any other clinical trial involving the investigational drug, or any other type of medical research deemed scientifically or medically incompatible with this trial.
38. Used the investigational drug within 8 weeks prior to the baseline return visit or within 5 half-lives (if known), whichever is longer.
Other Exclusions
39. Currently pregnant or breastfeeding, or planning to become pregnant or breastfeed during the trial.
40. Known allergy to any component of lebrikizumab.
41. Participant or caregiver unwilling to receive subcutaneous (SC) injection of the investigational drug.
The Estimated Number of Participants
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Taiwan
45 participants
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Global
206 participants
