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

NCT ID NCT06687967

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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) can reduce severe itching in adults with lichen simplex chronicus, a skin condition causing intense itch. 142 participants will receive either dupilumab or placebo injections for 24 weeks. The main goal is to see if more people get at least a 4-point drop on a 0–10 itch scale.

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 to ease severe itching in people with lichen simplex chronicus.
What could go wrong
This is a relatively small Phase 3 trial, and results may not apply to everyone. 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

142 people

The number who actually took part.

Started

Nov 2024

Finished

Aug 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Care Access - Arlington- Site Number : 8400022

    Arlington, Virginia, 22206, United States

  • Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011

    Houston, Texas, 77004, United States

  • Dermatology Research Associates - Los Angeles- Site Number : 8400004

    Los Angeles, California, 90045, United States

  • Equity Medical- Site Number : 8400017

    New York, New York, 10023, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1012, Argentina

  • Investigational Site Number : 0320002

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 1240001

    London, Ontario, N6H 5L5, Canada

  • Investigational Site Number : 1240002

    Saskatoon, Saskatchewan, S7K 0H6, Canada

  • Investigational Site Number : 1240005

    Edmonton, Alberta, T5K 2V4, Canada

  • Investigational Site Number : 1240007

    Mississauga, Ontario, L5H 1G9, Canada

  • Investigational Site Number : 1240008

    Québec, Quebec, G1W 4R4, Canada

  • Investigational Site Number : 1240009

    Montreal, Quebec, H1Y 3L1, Canada

  • Investigational Site Number : 1240010

    Regina, Saskatchewan, S4V 1R9, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1560001

    Shanghai, 200443, China

  • Investigational Site Number : 1560002

    Beijing, 100191, China

  • Investigational Site Number : 1560003

    Shijiazhuang, 050031, China

  • Investigational Site Number : 1560004

    Hangzhou, 310014, China

  • Investigational Site Number : 1560005

    Suzhou, 215006, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 1580003

    New Taipei City, 235, Taiwan

  • Investigational Site Number : 2030001

    Ostrava, 702 00, Czechia

  • Investigational Site Number : 2760001

    Magdeburg, 39104, Germany

  • Investigational Site Number : 2760003

    Bad Bentheim, 48455, Germany

  • Investigational Site Number : 3000001

    Athens, 124 62, Greece

  • Investigational Site Number : 3000002

    Thessaloniki, 546 42, Greece

  • Investigational Site Number : 3000003

    Thessaloniki, 564 29, Greece

  • Investigational Site Number : 3480001

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480002

    Kaposvár, 7400, Hungary

  • Investigational Site Number : 3800001

    Rome, Roma, 00133, Italy

  • Investigational Site Number : 3800002

    Bologna, 40138, Italy

  • Investigational Site Number : 3920001

    Kamiamakusa, Kumamoto, 861-3106, Japan

  • Investigational Site Number : 3920002

    Ebina-shi, Kanagawa, 243-0432, Japan

  • Investigational Site Number : 3920003

    Tachikawa, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3920005

    Kagoshima, 890-0063, Japan

  • Investigational Site Number : 3920007

    Sakai, Osaka, 593-8324, Japan

  • Investigational Site Number : 3920009

    Fukuoka, 819-0167, Japan

  • Investigational Site Number : 4840001

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840003

    Aguascalientes, 20127, Mexico

  • Investigational Site Number : 6200001

    Porto, 4099-001, Portugal

  • Investigational Site Number : 6200002

    Coimbra, 3000-075, Portugal

  • Investigational Site Number : 6200003

    Lisbon, 1998-018, Portugal

  • Investigational Site Number : 7240002

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240004

    Valencia, 46015, Spain

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7920001

    Samsun, 55139, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34662, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Adapazarı, 54100, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    London, England, E1 1BB, United Kingdom

  • Investigational Site Number : 8260002

    Milton Keynes, Buckinghamshire, MK19 6FG, United Kingdom

  • JDR Dermatology Research- Site Number : 8400023

    Las Vegas, Nevada, 89145, United States

  • MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014

    Houston, Texas, 77090, United States

  • Michigan Center for Research Company- Site Number : 8400013

    Clarkston, Michigan, 48346, United States

  • Onsite Clinical Solutions - Huntersville- Site Number : 8400033

    Huntersville, North Carolina, 28078, United States

  • Quality Care Clinical Research- Site Number : 8400034

    Miami, Florida, 33142, United States

  • Red River Research Partners - Fargo- Site Number : 8400007

    Fargo, North Dakota, 58103, United States

  • Wake Forest University Health Sciences- Site Number : 8400028

    Winston-Salem, North Carolina, 27104, United States

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