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Lichen Simplex ChronicusPhase 3NCT06687967

A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 1)

A Phase 3 study testing Dupilumab in people with Lichen Simplex Chronicus, run by Sanofi at 63 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lichen Simplex Chronicus
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
63 sitesin 17 countries
Study dates
28 Nov 2024to 31 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 17 countries.

63 sites in 17 countries

United States11 sites

  • Care Access - Arlington- Site Number : 8400022

    Arlington, Virginia, 22206

  • Michigan Center for Research Company- Site Number : 8400013

    Clarkston, Michigan, 48346

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

    Fargo, North Dakota, 58103

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

    Houston, Texas, 77004

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

    Houston, Texas, 77090

  • Onsite Clinical Solutions - Huntersville- Site Number : 8400033

    Huntersville, North Carolina, 28078

  • JDR Dermatology Research- Site Number : 8400023

    Las Vegas, Nevada, 89145

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

    Los Angeles, California, 90045

  • Quality Care Clinical Research- Site Number : 8400034

    Miami, Florida, 33142

  • Equity Medical- Site Number : 8400017

    New York, New York, 10023

  • Wake Forest University Health Sciences- Site Number : 8400028

    Winston-Salem, North Carolina, 27104

Other trials in United States

Canada7 sites

  • Investigational Site Number : 1240005

    Edmonton, Alberta, T5K 2V4

  • Investigational Site Number : 1240001

    London, Ontario, N6H 5L5

  • Investigational Site Number : 1240007

    Mississauga, Ontario, L5H 1G9

  • Investigational Site Number : 1240009

    Montreal, Quebec, H1Y 3L1

  • Investigational Site Number : 1240008

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240010

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240002

    Saskatoon, Saskatchewan, S7K 0H6

Other trials in Canada

Japan6 sites

  • Investigational Site Number : 3920002

    Ebina-shi, Kanagawa, 243-0432

  • Investigational Site Number : 3920009

    Fukuoka, 819-0167

  • Investigational Site Number : 3920005

    Kagoshima, 890-0063

  • Investigational Site Number : 3920001

    Kamiamakusa, Kumamoto, 861-3106

  • Investigational Site Number : 3920007

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3920003

    Tachikawa, Tokyo, 190-0023

Other trials in Japan

China5 sites

  • Investigational Site Number : 1560002

    Beijing, 100191

  • Investigational Site Number : 1560004

    Hangzhou, 310014

  • Investigational Site Number : 1560001

    Shanghai, 200443

  • Investigational Site Number : 1560003

    Shijiazhuang, 050031

  • Investigational Site Number : 1560005

    Suzhou, 215006

Other trials in China

Argentina4 sites

  • Investigational Site Number : 0320001

    Buenos Aires, 1012

  • Investigational Site Number : 0320004

    Buenos Aires, 1061

  • Investigational Site Number : 0320002

    Mendoza, 5500

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Spain4 sites

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08036

  • Investigational Site Number : 7240002

    Barcelona, Catalunya [Cataluña], 08041

  • Investigational Site Number : 7240004

    Valencia, 46015

Other trials in Spain

Chile3 sites

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8420383

Other trials in Chile

Greece3 sites

  • Investigational Site Number : 3000001

    Athens, 124 62

  • Investigational Site Number : 3000002

    Thessaloniki, 546 42

  • Investigational Site Number : 3000003

    Thessaloniki, 564 29

Other trials in Greece

Portugal3 sites

  • Investigational Site Number : 6200002

    Coimbra, 3000-075

  • Investigational Site Number : 6200003

    Lisbon, 1998-018

  • Investigational Site Number : 6200001

    Porto, 4099-001

Other trials in Portugal

Taiwan3 sites

  • Investigational Site Number : 1580002

    Kaohsiung City, 833

  • Investigational Site Number : 1580003

    New Taipei City, 235

  • Investigational Site Number : 1580001

    Taipei, 100

Other trials in Taiwan

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920003

    Adapazarı, 54100

  • Investigational Site Number : 7920002

    Istanbul, 34662

  • Investigational Site Number : 7920001

    Samsun, 55139

Other trials in Turkey (Türkiye)

Germany2 sites

  • Investigational Site Number : 2760003

    Bad Bentheim, 48455

  • Investigational Site Number : 2760001

    Magdeburg, 39104

Other trials in Germany

Hungary2 sites

  • Investigational Site Number : 3480001

    Debrecen, 4032

  • Investigational Site Number : 3480002

    Kaposvár, 7400

Other trials in Hungary

Italy2 sites

  • Investigational Site Number : 3800002

    Bologna, 40138

  • Investigational Site Number : 3800001

    Rome, Roma, 00133

Other trials in Italy

Mexico2 sites

  • Investigational Site Number : 4840003

    Aguascalientes, 20127

  • Investigational Site Number : 4840001

    Chihuahua City, 31000

Other trials in Mexico

United Kingdom2 sites

  • Investigational Site Number : 8260001

    London, England, E1 1BB

  • Investigational Site Number : 8260002

    Milton Keynes, Buckinghamshire, MK19 6FG

Other trials in United Kingdom

Czechia1 site

  • Investigational Site Number : 2030001

    Ostrava, 702 00

Other trials in Czechia

About this study

Official title: 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

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.

Being tested
Dupilumab, Placebo
Medical subject headings
Neurodermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called SAR231893, Dupixent

    Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

  • PlaceboDrug

    Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

Study groups in NCT06687967
Study groupRoleWhat they receive
DupilumabExperimentalDupilumab subcutaneous injection as per protocol
Receives: Drug: Dupilumab
PlaceboPlacebo comparatorPlacebo subcutaneous injection as per protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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").

    Measured: Week 24

Secondary outcomes (11)

  1. 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").

    Measured: Baseline to Week 24

  2. 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").

    Measured: Baseline to Week 24

  3. 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").

    Measured: Baseline to Week 24

  4. 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").

    Measured: Baseline to Week 24

  5. 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

    Measured: Baseline to Week 24

  6. 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.

    Measured: Baseline to Week 24

  7. 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").

    Measured: Week 12

  8. 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)

    Measured: Week 12 and 24

  9. 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).

    Measured: Baseline through Week 24

  10. Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab

    Measured: Baseline through Week 36

  11. Percentage of participants experiencing treatment-emergent adverse event (TEAEs) or serious adverse event (SAEs)

    Measured: Baseline through Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start28 Nov 2024
  3. Primary completion8 Jun 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687967
Sponsor's protocol ID
EFC18365
Other IDs
2024-514737-37-00, U1111-1307-7329
Status last verified
Sep 2026
First submitted
12 Nov 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Lichen Simplex Chronicus, run by Sanofi at 63 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada, Japan, China, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06687967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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