A Phase 3 interventional study of Dupilumab and Placebo in Lichen Simplex Chronicus, sponsored by Sanofi. Completed at 63 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC.
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
22 studies on the registry are indexed under Neurodermatitis; 3 are open to participants now.
This study's enrollment of 138 is above the median of 44 across 22 interventional studies indexed under Neurodermatitis.
Browse Neurodermatitis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified):
Participants with moderate-to-severe LSC, as defined by Investigator's Global Assessment (IGA) score ≥3 and one or more of the following:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified):
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dupilumab subcutaneous injection as per protocol
Drug: Dupilumab
Placebo subcutaneous injection as per protocol
Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Also known as: SAR231893, Dupixent
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Worst-Itch numerical rating score (WI-NRS) is a patient report outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Time frame: Week 24
Absolute change in weekly average of daily WI-NRS from baseline to Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Time frame: Baseline to Week 24
Percentage change in weekly average of daily WI-NRS from baseline to Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Time frame: Baseline to Week 24
Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
The Itch-related Sleep Disturbance NRS is a single-item PRO to report the degree of sleep loss related to itch over the past 24 hours, from 0 ("no sleep loss related to itch") to 10 ("I cannot sleep at all due to itch").
Time frame: Baseline to Week 24
Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
The Itch-related Sleep Disturbance NRS is a single-item PRO to report the degree of sleep loss related to itch over the past 24 hours, from 0 ("no sleep loss related to itch") to 10 ("I cannot sleep at all due to itch").
Time frame: Baseline to Week 24
Absolute change in ItchyQoL score from baseline to Week 24
Itchy quality of life survey (ItchyQoL) is a pruritus-specific QoL instrument to measure dermatology-specific QoL in patients aged 16 years and older. The overall score ranging from 1 to 5. A higher score corresponds to a more adverse impact on health-related QoL
Time frame: Baseline to Week 24
Absolute change in DLQI total score from baseline to Week 24
Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer health-related QoL.
Time frame: Baseline to Week 24
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Time frame: Week 12
Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24
Investigator's Global Assessment (IGA) for LSC is a clinician-reported outcome using a 5-point scale from 0 (clear) to 4 (severe).
Time frame: Week 12 and 24
Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). IGA for LSC is a clinician-reported outcome using a 5-point scale from 0 (clear) to 4 (severe).
Time frame: Baseline through Week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab
Time frame: Baseline through Week 36
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time frame: Baseline through Week 36
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Jun 2026, 18 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab