Clinical Trials List
Protocol NumberDRM06-AD05/J2T-DM-KGAC
NCT Number(ClinicalTrials.gov Identfier)NCT04178967
2019-04-01 - 2022-06-20
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 Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
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Trial Applicant
Syneos Health
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Sponsor
Dermira, Inc. (Eli Lilly and Company)
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 張廖年峰 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 紀景琪 Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Chun-Bing Chen Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- 王芳穎 Division of Dermatology
- I-Hsin Shih Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- 陳偉迪 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Lun Chou Division of Dermatology
- YUN-WEN CHIU Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- 卓雍哲 Division of Dermatology
- WEI-HSIN WU Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳盈君 Division of Dermatology
- Sheng Yiao Lin Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Atopic Dermatitis
Objectives
The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Test Drug
Lebrikizumab
Active Ingredient
Lebrikizumab
Dosage Form
injection
Dosage
125
Endpoints
Primary Outcome Measures :
Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Percentage of participants achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Percentage of participants achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Inclution Criteria
1. Male or female adults and adolescents (≥12 years and ≥40 kg).
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that
has been present for ≥1 year before the screening visit (see Appendix 2).
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit (Appendix 4).
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit (see Section 8.2.1).
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit (Appendix 3).
6. History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable.
7. Apply a stable dose of moisturizer at least twice daily for ≥7 days prior to the baseline visit.
8. Completed electronic diary entries for pruritus and sleep-loss for a minimum of 4 of 7 days preceding randomization.
9. Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
10. For women of childbearing potential: agree to remain abstinent (refrain from
heterosexual intercourse) or use an acceptable contraceptive method during the treatment
period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal
female, who has not reached a postmenopausal state (≥ 12 continuous months of
amenorrhea with no identified cause other than menopause), and has not undergone
surgical sterilization (removal of ovaries and/or uterus).
NOTE: The following are acceptable contraceptive methods: abstinence, hormonal
contraceptives (oral/implant/injectable/transdermal), intrauterine device, double-barrier
contraception (i.e., condom + diaphragm), same sex partner, or a male partner with
vasectomy. The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
withdrawal are not acceptable methods of contraception.
11. Male patients must agree to use an effective barrier method of contraception during the
study and for a minimum of three months following the last dose of study drug if sexually
active with a female of child bearing potential
12. Provide signed informed consent/assent.
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that
has been present for ≥1 year before the screening visit (see Appendix 2).
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit (Appendix 4).
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit (see Section 8.2.1).
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit (Appendix 3).
6. History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable.
7. Apply a stable dose of moisturizer at least twice daily for ≥7 days prior to the baseline visit.
8. Completed electronic diary entries for pruritus and sleep-loss for a minimum of 4 of 7 days preceding randomization.
9. Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
10. For women of childbearing potential: agree to remain abstinent (refrain from
heterosexual intercourse) or use an acceptable contraceptive method during the treatment
period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal
female, who has not reached a postmenopausal state (≥ 12 continuous months of
amenorrhea with no identified cause other than menopause), and has not undergone
surgical sterilization (removal of ovaries and/or uterus).
NOTE: The following are acceptable contraceptive methods: abstinence, hormonal
contraceptives (oral/implant/injectable/transdermal), intrauterine device, double-barrier
contraception (i.e., condom + diaphragm), same sex partner, or a male partner with
vasectomy. The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
withdrawal are not acceptable methods of contraception.
11. Male patients must agree to use an effective barrier method of contraception during the
study and for a minimum of three months following the last dose of study drug if sexually
active with a female of child bearing potential
12. Provide signed informed consent/assent.
Exclusion Criteria
1. Participation in a prior lebrikizumab clinical study.
2. History of anaphylaxis as defined by the Sampson criteria (Sampson, 2006).
3. Treatment with topical corticosteroids, calcineurin inhibitors or Eucrisa within 1 week
prior to the baseline visit.
4. Prior treatment with dupilumab or tralokinumab.
5. Treatment with any of the following agents within 4 weeks prior to the baseline visit:
a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
methotrexate, etc.)
b. Phototherapy and photochemotherapy (PUVA) for AD.
6. Treatment with the following prior to the baseline visit:
a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
longer.
b. Cell-depleting biologics, including rituximab, within 6 months.
c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
7. Use of prescription moisturizers within 7 days of the baseline visit.
8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the
screening visit.
9. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study.
10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., comorbid severe uncontrolled asthma (defined by an ACQ-5 score ≥1.5 or a history of
≥ 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or
parenteral] corticosteroid treatment or hospitalization for > 24 hours).
11. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or
superficial skin infections within 1 week before the baseline visit.
NOTE: patients may be rescreened after infection resolves.
12. Evidence of active acute or chronic hepatitis (as defined by the Department of Health &
Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
13. Diagnosed active endoparasitic infections or at high risk of these infections.
14. Known or suspected history of immunosuppression, including history of invasive
opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis,
coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or
unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment.
15. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
16. In the Investigator’s opinion, any clinically significant laboratory results from the
chemistry, hematology or urinalysis tests obtained at the screening visit.
17. Presence of skin comorbidities that may interfere with study assessments.
18. History of malignancy, including mycosis fungoides, within 5 years before the screening
visit, except completely treated in situ carcinoma of the cervix, completely treated and
resolved non-metastatic squamous or basal cell carcinoma of the skin.
19. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect
the patient’s participation in the study. Any other medical or psychological condition that
in the opinion of the Investigator may suggest a new and/or insufficiently understood
disease, may present an unreasonable risk to the study patient because of his/her
participation in this clinical trial, may make patient’s participation unreliable, or may interfere with study assessments.
20. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
2. History of anaphylaxis as defined by the Sampson criteria (Sampson, 2006).
3. Treatment with topical corticosteroids, calcineurin inhibitors or Eucrisa within 1 week
prior to the baseline visit.
4. Prior treatment with dupilumab or tralokinumab.
5. Treatment with any of the following agents within 4 weeks prior to the baseline visit:
a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
methotrexate, etc.)
b. Phototherapy and photochemotherapy (PUVA) for AD.
6. Treatment with the following prior to the baseline visit:
a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
longer.
b. Cell-depleting biologics, including rituximab, within 6 months.
c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
7. Use of prescription moisturizers within 7 days of the baseline visit.
8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the
screening visit.
9. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study.
10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., comorbid severe uncontrolled asthma (defined by an ACQ-5 score ≥1.5 or a history of
≥ 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or
parenteral] corticosteroid treatment or hospitalization for > 24 hours).
11. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or
superficial skin infections within 1 week before the baseline visit.
NOTE: patients may be rescreened after infection resolves.
12. Evidence of active acute or chronic hepatitis (as defined by the Department of Health &
Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
13. Diagnosed active endoparasitic infections or at high risk of these infections.
14. Known or suspected history of immunosuppression, including history of invasive
opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis,
coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or
unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment.
15. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
16. In the Investigator’s opinion, any clinically significant laboratory results from the
chemistry, hematology or urinalysis tests obtained at the screening visit.
17. Presence of skin comorbidities that may interfere with study assessments.
18. History of malignancy, including mycosis fungoides, within 5 years before the screening
visit, except completely treated in situ carcinoma of the cervix, completely treated and
resolved non-metastatic squamous or basal cell carcinoma of the skin.
19. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect
the patient’s participation in the study. Any other medical or psychological condition that
in the opinion of the Investigator may suggest a new and/or insufficiently understood
disease, may present an unreasonable risk to the study patient because of his/her
participation in this clinical trial, may make patient’s participation unreliable, or may interfere with study assessments.
20. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
400 participants
