Can an eczema drug stop the itch of lichen simplex chronicus?
NCT ID NCT06687967
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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142 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Aug 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Care Access - Arlington- Site Number : 8400022
Arlington, Virginia, 22206, United States
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Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011
Houston, Texas, 77004, United States
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Dermatology Research Associates - Los Angeles- Site Number : 8400004
Los Angeles, California, 90045, United States
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Equity Medical- Site Number : 8400017
New York, New York, 10023, United States
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Investigational Site Number : 0320001
Buenos Aires, 1012, Argentina
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Investigational Site Number : 0320002
Mendoza, 5500, Argentina
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Investigational Site Number : 0320003
Rosario, Santa Fe Province, 2000, Argentina
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Investigational Site Number : 0320004
Buenos Aires, 1061, Argentina
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Investigational Site Number : 1240001
London, Ontario, N6H 5L5, Canada
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Investigational Site Number : 1240002
Saskatoon, Saskatchewan, S7K 0H6, Canada
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Investigational Site Number : 1240005
Edmonton, Alberta, T5K 2V4, Canada
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Investigational Site Number : 1240007
Mississauga, Ontario, L5H 1G9, Canada
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Investigational Site Number : 1240008
Québec, Quebec, G1W 4R4, Canada
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Investigational Site Number : 1240009
Montreal, Quebec, H1Y 3L1, Canada
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Investigational Site Number : 1240010
Regina, Saskatchewan, S4V 1R9, Canada
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Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7640881, Chile
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Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7580206, Chile
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Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 8420383, Chile
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Investigational Site Number : 1560001
Shanghai, 200443, China
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Investigational Site Number : 1560002
Beijing, 100191, China
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Investigational Site Number : 1560003
Shijiazhuang, 050031, China
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Investigational Site Number : 1560004
Hangzhou, 310014, China
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Investigational Site Number : 1560005
Suzhou, 215006, China
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Investigational Site Number : 1580001
Taipei, 100, Taiwan
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Investigational Site Number : 1580002
Kaohsiung City, 833, Taiwan
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Investigational Site Number : 1580003
New Taipei City, 235, Taiwan
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Investigational Site Number : 2030001
Ostrava, 702 00, Czechia
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Investigational Site Number : 2760001
Magdeburg, 39104, Germany
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Investigational Site Number : 2760003
Bad Bentheim, 48455, Germany
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Investigational Site Number : 3000001
Athens, 124 62, Greece
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Investigational Site Number : 3000002
Thessaloniki, 546 42, Greece
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Investigational Site Number : 3000003
Thessaloniki, 564 29, Greece
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Investigational Site Number : 3480001
Debrecen, 4032, Hungary
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Investigational Site Number : 3480002
Kaposvár, 7400, Hungary
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Investigational Site Number : 3800001
Rome, Roma, 00133, Italy
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Investigational Site Number : 3800002
Bologna, 40138, Italy
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Investigational Site Number : 3920001
Kamiamakusa, Kumamoto, 861-3106, Japan
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Investigational Site Number : 3920002
Ebina-shi, Kanagawa, 243-0432, Japan
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Investigational Site Number : 3920003
Tachikawa, Tokyo, 190-0023, Japan
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Investigational Site Number : 3920005
Kagoshima, 890-0063, Japan
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Investigational Site Number : 3920007
Sakai, Osaka, 593-8324, Japan
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Investigational Site Number : 3920009
Fukuoka, 819-0167, Japan
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Investigational Site Number : 4840001
Chihuahua City, 31000, Mexico
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Investigational Site Number : 4840003
Aguascalientes, 20127, Mexico
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Investigational Site Number : 6200001
Porto, 4099-001, Portugal
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Investigational Site Number : 6200002
Coimbra, 3000-075, Portugal
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Investigational Site Number : 6200003
Lisbon, 1998-018, Portugal
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Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], 08041, Spain
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Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], 08035, Spain
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Investigational Site Number : 7240004
Valencia, 46015, Spain
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Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], 08036, Spain
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Investigational Site Number : 7920001
Samsun, 55139, Turkey (Türkiye)
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Investigational Site Number : 7920002
Istanbul, 34662, Turkey (Türkiye)
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Investigational Site Number : 7920003
Adapazarı, 54100, Turkey (Türkiye)
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Investigational Site Number : 8260001
London, England, E1 1BB, United Kingdom
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Investigational Site Number : 8260002
Milton Keynes, Buckinghamshire, MK19 6FG, United Kingdom
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JDR Dermatology Research- Site Number : 8400023
Las Vegas, Nevada, 89145, United States
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MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014
Houston, Texas, 77090, United States
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Michigan Center for Research Company- Site Number : 8400013
Clarkston, Michigan, 48346, United States
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Onsite Clinical Solutions - Huntersville- Site Number : 8400033
Huntersville, North Carolina, 28078, United States
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Quality Care Clinical Research- Site Number : 8400034
Miami, Florida, 33142, United States
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Red River Research Partners - Fargo- Site Number : 8400007
Fargo, North Dakota, 58103, United States
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Wake Forest University Health Sciences- Site Number : 8400028
Winston-Salem, North Carolina, 27104, United States
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