Clinical Trials List
Protocol NumberEFC18365
Active
2025-03-01 - 2027-12-31
Phase III
Recruiting3
ICD-10L28.0
Lichen simplex chronicus
ICD-10L28.1
Prurigo nodularis
ICD-9698.3
Lichenification and lichen simplex chronicus
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults
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Trial Applicant
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Sponsor
Sanofi-Aventis Recherche & Développement
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 鄭裕文 Division of Dermatology
- 林尚宏 Division of Dermatology
- Lai San Wong Division of Dermatology
- 曾涵琪 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳柏樺 Division of Dermatology
- 黃柏瑋 Division of Dermatology
- WEI-HSIN WU Division of Dermatology
- 謝博丞 Division of Dermatology
- 卓雍哲 Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Woan-Ruoh Lee
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Lichen Simplex Chronicus (LSC)
Objectives
To demonstrate the efficacy of dupilumab on
pruritus of LSC in adult participants with moderateto-
severe LSC inadequately controlled by topical
therapies
Test Drug
injection
Active Ingredient
Dupilumab
Dosage Form
230
Dosage
300mg/2ml
Endpoints
Proportion of participants with improvement
(reduction) in weekly average of daily WI-NRS by
≥4 from baseline to Week 24
(reduction) in weekly average of daily WI-NRS by
≥4 from baseline to Week 24
Inclution Criteria
I 01. Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in
which the study is taking place at the time of signing the informed consent.
I 02. Participants with moderate-to-severe LSC, as defined by IGA score ≥3 and one or more of
the following:
• at least 1 single anogenital lesion;
• at least 2 lesions including 1 lesion of ≥3 cm in diameter;
• at least 1 severe lesion (IGA score = 4).
I 03. History of LSC for at least 6 months prior to the screening visit.
I 04. On the WI-NRS ranging from 0 to 10, participants must have an average worst-itch of LSC
score of ≥7 in the 7 days prior to Day 1. A minimum of 4 daily scores out of the 7 days is
required to calculate the baseline average score. For participants who do not have at least
4 daily scores reported during the 7 days immediately preceding the planned
randomization date, randomization can be postponed until this requirement is met, but
without exceeding the 28-day maximum duration of the screening period.
I 05. History of failing a 2-week course of medium-to-superpotent TCS +/- TCI for the
treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable.
Patients with documented systemic treatment for LSC (other than antihistamines) in the
past 6 months are also considered as inadequate responders to topical treatments and are
potentially eligible for treatment with dupilumab after appropriate washout (Table 3).
I 06. All
Contraceptive use by women should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and
one of the following conditions applies:
- Is a WONCBP as defined in Section 10.4 (Contraceptive and barrier guidance).
OR
- Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a
failure rate of <1%, as described in Section 10.4 (Contraceptive and barrier guidance)
during the study intervention period (to be effective before starting the intervention)
and for at least 12 weeks after the last administration of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and
on Day 1 (urine) before the first administration of study intervention, see Section 8.3.5
(Pregnancy testing). If a urine test cannot be confirmed as negative (eg, an ambiguous
result), a serum pregnancy test is required. In such cases, the participant must be excluded
from participation if the serum pregnancy result is positive.
I 07. Capable of giving signed informed consent as described in Section 10.1 which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
which the study is taking place at the time of signing the informed consent.
I 02. Participants with moderate-to-severe LSC, as defined by IGA score ≥3 and one or more of
the following:
• at least 1 single anogenital lesion;
• at least 2 lesions including 1 lesion of ≥3 cm in diameter;
• at least 1 severe lesion (IGA score = 4).
I 03. History of LSC for at least 6 months prior to the screening visit.
I 04. On the WI-NRS ranging from 0 to 10, participants must have an average worst-itch of LSC
score of ≥7 in the 7 days prior to Day 1. A minimum of 4 daily scores out of the 7 days is
required to calculate the baseline average score. For participants who do not have at least
4 daily scores reported during the 7 days immediately preceding the planned
randomization date, randomization can be postponed until this requirement is met, but
without exceeding the 28-day maximum duration of the screening period.
I 05. History of failing a 2-week course of medium-to-superpotent TCS +/- TCI for the
treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable.
Patients with documented systemic treatment for LSC (other than antihistamines) in the
past 6 months are also considered as inadequate responders to topical treatments and are
potentially eligible for treatment with dupilumab after appropriate washout (Table 3).
I 06. All
Contraceptive use by women should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and
one of the following conditions applies:
- Is a WONCBP as defined in Section 10.4 (Contraceptive and barrier guidance).
OR
- Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a
failure rate of <1%, as described in Section 10.4 (Contraceptive and barrier guidance)
during the study intervention period (to be effective before starting the intervention)
and for at least 12 weeks after the last administration of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and
on Day 1 (urine) before the first administration of study intervention, see Section 8.3.5
(Pregnancy testing). If a urine test cannot be confirmed as negative (eg, an ambiguous
result), a serum pregnancy test is required. In such cases, the participant must be excluded
from participation if the serum pregnancy result is positive.
I 07. Capable of giving signed informed consent as described in Section 10.1 which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria
E 01. Participants diagnosed with active lesions of PN (broadly distributed nodules) or active
lesions of AD within 6 months, contact dermatitis, psoriasis, CTCL (or suspected of
CTCL), vulvar lichen planus, or vulvar lichen sclerosus.
Note: For vulvar location of lesions, a prior biopsy is recommended to be available to
exclude vulvar lichen planus or vulvar lichen sclerosus.
E 02. Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may
interfere with the assessment of the study outcomes. For example: scabies, insect bite,folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis,
sporotrichosis, bullous disease, lichen planus hypertrophicus.
E 03. Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect
the patient’s participation in the study. Examples include, but are not limited to participants
with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%),
participants with cardiovascular conditions (eg, Class III or IV cardiac failure according to
the New York Heart Association classification), severe renal conditions (eg, participants
on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological
conditions (eg, demyelinating diseases), autoimmune diseases (eg, lupus, inflammatory
bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal,
metabolic, pulmonary, or lymphatic diseases. The specific justification for participants
excluded under this criterion will be noted in study documents (chart notes, CRFs, etc).
E 04. Severe psychiatric disease that, in the Investigator’s judgement, would affect the study
intervention evaluation.
E 05. Patients with active TB or non-tuberculous mycobacterial infection, or a history of
incompletely treated TB will be excluded from the study unless it is well documented that
the participant has been adequately treated and can now start treatment with a biologic
agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB
testing will be performed on a country-by-country basis, according to local guidelines if
required by regulatory authorities or ethics boards, or if TB is suspected by the
investigator.
E 06. Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of
antiparasitic drug within 2 weeks before the screening visit (Visit 1) or during the
screening period.
E 07. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
or antifungals within 2 weeks before the screening visit (Visit 1) or during the screening
period.
NOTE: Participants may be rescreened after infection resolves.
E 08. Known or suspected immunodeficiency, including history of invasive opportunistic
infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and
aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal
frequency or prolonged duration suggesting an immune compromised status, as judged by
the Investigator.
E 09. Active malignancy or history of malignancy within 5 years before the baseline visit, except
completely treated in situ carcinoma of the cervix and completely treated and resolved non
metastatic squamous or basal cell carcinoma of the skin.
E 10. History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
E 11. Known or suspected alcohol and/or drug abuse.\E 12. Planned or anticipated major surgical procedure during the participant’s participation in
this clinical trial.
lesions of AD within 6 months, contact dermatitis, psoriasis, CTCL (or suspected of
CTCL), vulvar lichen planus, or vulvar lichen sclerosus.
Note: For vulvar location of lesions, a prior biopsy is recommended to be available to
exclude vulvar lichen planus or vulvar lichen sclerosus.
E 02. Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may
interfere with the assessment of the study outcomes. For example: scabies, insect bite,folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis,
sporotrichosis, bullous disease, lichen planus hypertrophicus.
E 03. Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect
the patient’s participation in the study. Examples include, but are not limited to participants
with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%),
participants with cardiovascular conditions (eg, Class III or IV cardiac failure according to
the New York Heart Association classification), severe renal conditions (eg, participants
on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological
conditions (eg, demyelinating diseases), autoimmune diseases (eg, lupus, inflammatory
bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal,
metabolic, pulmonary, or lymphatic diseases. The specific justification for participants
excluded under this criterion will be noted in study documents (chart notes, CRFs, etc).
E 04. Severe psychiatric disease that, in the Investigator’s judgement, would affect the study
intervention evaluation.
E 05. Patients with active TB or non-tuberculous mycobacterial infection, or a history of
incompletely treated TB will be excluded from the study unless it is well documented that
the participant has been adequately treated and can now start treatment with a biologic
agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB
testing will be performed on a country-by-country basis, according to local guidelines if
required by regulatory authorities or ethics boards, or if TB is suspected by the
investigator.
E 06. Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of
antiparasitic drug within 2 weeks before the screening visit (Visit 1) or during the
screening period.
E 07. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
or antifungals within 2 weeks before the screening visit (Visit 1) or during the screening
period.
NOTE: Participants may be rescreened after infection resolves.
E 08. Known or suspected immunodeficiency, including history of invasive opportunistic
infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and
aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal
frequency or prolonged duration suggesting an immune compromised status, as judged by
the Investigator.
E 09. Active malignancy or history of malignancy within 5 years before the baseline visit, except
completely treated in situ carcinoma of the cervix and completely treated and resolved non
metastatic squamous or basal cell carcinoma of the skin.
E 10. History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
E 11. Known or suspected alcohol and/or drug abuse.\E 12. Planned or anticipated major surgical procedure during the participant’s participation in
this clinical trial.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
136 participants
