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Investigating Dupilumab for Itch Relief in 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

Phase 3 Interventional Sanofi · NCT06687967

This study is testing if dupilumab injections can help relieve itchiness in adults with moderate-to-severe lichen simplex chronicus compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment136 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations49 sites (Los Angeles, California and 48 other locations)
Trial IDNCT06687967 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the effectiveness of dupilumab injections in reducing itchiness associated with lichen simplex chronicus compared to a placebo. The study involves male and female participants aged 18 and older who have moderate-to-severe symptoms. Participants will receive either dupilumab or a placebo for up to 24 weeks, followed by a 12-week follow-up period. The study aims to measure improvement in pruritus using standardized assessment scales.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate-to-severe lichen simplex chronicus and a high level of itch severity.

Not a fit: Patients with mild lichen simplex chronicus or those who do not meet the severity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the debilitating itch associated with lichen simplex chronicus, improving patients' quality of life.

How similar studies have performed: Previous studies have shown promising results with dupilumab for other dermatological conditions, suggesting potential success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified):

* 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.
* Participants with moderate-to-severe LSC, as defined by Investigator's Global Assessment (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).
* History of LSC for at least 6 months prior to the screening visit.
* On the Worst-Itch Numerical Rating Scale (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.
* History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (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.
* Appropriate contraceptive measures

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified):

* Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) XE "CTCL" \\f Abbreviation \\t "cutaneous T-cell lymphoma" (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus.
* 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.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
* Severe psychiatric disease that, in the Investigator's judgement, would affect the study intervention evaluation.
* Having received or planning to use any of the treatments within the timeframe as specified in the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Los Angeles, California and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lichen Simplex Chronicus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.