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Can an eczema drug stop the relentless itch of lichen simplex chronicus?

NCT ID NCT06687980

Symptom relief Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether dupilumab (Dupixent) injections can reduce severe itching in adults with lichen simplex chronicus, a skin condition causing intense, persistent itch. About 138 participants will receive either dupilumab or a placebo for 24 weeks. The main goal is to see if at least a 4-point improvement on a 0-10 itch scale is achieved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If it works, this could provide a new treatment option for severe itching in lichen simplex chronicus, improving quality of life.
What could go wrong
This is a relatively small Phase 3 trial, and the drug may not work better than placebo. Dupilumab can cause injection site reactions and allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

138 people

The number who actually took part.

Started

Nov 2024

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neurodermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lichen simplex chronicus

Contacts and locations

Locations

  • Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203

    Pflugerville, Texas, 78660, United States

  • Bellaire Dermatology Associates,- Site Number : 8400202

    Bellaire, Texas, 77401, United States

  • Brigham & Women's Hospital- Site Number : 8400229

    Boston, Massachusetts, 02115, United States

  • Center for Dermatology Clinical Research- Site Number : 8400226

    Fremont, California, 94538, United States

  • Clinical Research of Philadelphia- Site Number : 8400215

    Philadelphia, Pennsylvania, 19114, United States

  • Cosmetic Dermatology of Orange County- Site Number : 8400232

    Anaheim, California, 92807, United States

  • Equity Medical - Bowling Green- Site Number : 8400240

    Bowling Green, Kentucky, 42104, United States

  • Investigational Site Number : 0320201

    Buenos Aires, 1427, Argentina

  • Investigational Site Number : 0320202

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320203

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320204

    Berazategui, Buenos Aires, 1886, Argentina

  • Investigational Site Number : 0560202

    Alken, 3570, Belgium

  • Investigational Site Number : 0560203

    Maldegem, 9990, Belgium

  • Investigational Site Number : 1240201

    Surrey, British Columbia, V3R 6A7, Canada

  • Investigational Site Number : 1240203

    Verdun, Quebec, H4G 2L8, Canada

  • Investigational Site Number : 1240205

    London, Ontario, L6A 2C2, Canada

  • Investigational Site Number : 1240207

    Edmonton, Alberta, T6W 0J5, Canada

  • Investigational Site Number : 1240208

    Markham, Ontario, L3P 1X3, Canada

  • Investigational Site Number : 1240209

    Toronto, Ontario, M2N 3A6, Canada

  • Investigational Site Number : 1240210

    Calgary, Alberta, T2W 4X9, Canada

  • Investigational Site Number : 1520201

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1520202

    Santiago, Reg Metropolitana de Santiago, 7500505, Chile

  • Investigational Site Number : 1560201

    Guangzhou, 510018, China

  • Investigational Site Number : 1560202

    Guangzhou, 510120, China

  • Investigational Site Number : 1560203

    Wuhan, 430022, China

  • Investigational Site Number : 1560204

    Chongqing, 400038, China

  • Investigational Site Number : 1560206

    Guangzhou, 510000, China

  • Investigational Site Number : 1580201

    Taoyuan City, 333, Taiwan

  • Investigational Site Number : 1580202

    Taichung, 404, Taiwan

  • Investigational Site Number : 1580203

    Hsinchu, 300, Taiwan

  • Investigational Site Number : 2030201

    Prague, 110 01, Czechia

  • Investigational Site Number : 2030202

    Prague, 160 00, Czechia

  • Investigational Site Number : 2030203

    Prague, 180 81, Czechia

  • Investigational Site Number : 2760201

    Berlin, 12203, Germany

  • Investigational Site Number : 2760203

    Kiel, 24105, Germany

  • Investigational Site Number : 2760205

    Hamburg, 20095, Germany

  • Investigational Site Number : 3000201

    Athens, 161 21, Greece

  • Investigational Site Number : 3000202

    Ioannina, 455 00, Greece

  • Investigational Site Number : 3000203

    Athens, 142 33, Greece

  • Investigational Site Number : 3480201

    Pécs, 7632, Hungary

  • Investigational Site Number : 3480202

    Orosháza, 5900, Hungary

  • Investigational Site Number : 3800201

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3800202

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 4100201

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100202

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Investigational Site Number : 4100203

    Bupyeong-gu, Incheon-gwangyeoksi, 21431, South Korea

  • Investigational Site Number : 4100204

    Seoul, Seoul-teukbyeolsi, 03312, South Korea

  • Investigational Site Number : 4840201

    Guadalajara, Jalisco, 44657, Mexico

  • Investigational Site Number : 4840202

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 4840203

    Mérida, Yucatán, 97070, Mexico

  • Investigational Site Number : 7240201

    Madrid, 28046, Spain

  • Investigational Site Number : 7240202

    Madrid, 28034, Spain

  • Investigational Site Number : 7240203

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Investigational Site Number : 7240204

    Alicante, 03010, Spain

  • Investigational Site Number : 7920201

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920202

    Gaziantep, 27310, Turkey (Türkiye)

  • Investigational Site Number : 7920203

    Istanbul, 34722, Turkey (Türkiye)

  • Investigational Site Number : 8260201

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • Progressive Clinical Research - San Antonio- Site Number : 8400206

    San Antonio, Texas, 78229, United States

  • Skin Care Physicians of Georgia - Macon- Site Number : 8400236

    Macon, Georgia, 31217, United States

  • Southern Indiana Clinical Research Center- Site Number : 8400230

    Columbus, Indiana, 47201, United States

  • TrueBlue Clinical Research- Site Number : 8400208

    Tampa, Florida, 33609, United States

  • University of Miami Miller School of Medicine- Site Number : 8400218

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.