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Lichen Simplex ChronicusPhase 3NCT06687980

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 2)

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
138 participants
Where
63 sitesin 17 countries
Study dates
25 Nov 2024to 2 Sep 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 States12 sites

  • Cosmetic Dermatology of Orange County- Site Number : 8400232

    Anaheim, California, 92807

  • Bellaire Dermatology Associates,- Site Number : 8400202

    Bellaire, Texas, 77401

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

    Boston, Massachusetts, 02115

  • Equity Medical - Bowling Green- Site Number : 8400240

    Bowling Green, Kentucky, 42104

  • Southern Indiana Clinical Research Center- Site Number : 8400230

    Columbus, Indiana, 47201

  • Center for Dermatology Clinical Research- Site Number : 8400226

    Fremont, California, 94538

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

    Macon, Georgia, 31217

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

    Miami, Florida, 33136

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

    Pflugerville, Texas, 78660

  • Clinical Research of Philadelphia- Site Number : 8400215

    Philadelphia, Pennsylvania, 19114

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

    San Antonio, Texas, 78229

  • TrueBlue Clinical Research- Site Number : 8400208

    Tampa, Florida, 33609

Other trials in United States

Canada7 sites

  • Investigational Site Number : 1240210

    Calgary, Alberta, T2W 4X9

  • Investigational Site Number : 1240207

    Edmonton, Alberta, T6W 0J5

  • Investigational Site Number : 1240205

    London, Ontario, L6A 2C2

  • Investigational Site Number : 1240208

    Markham, Ontario, L3P 1X3

  • Investigational Site Number : 1240201

    Surrey, British Columbia, V3R 6A7

  • Investigational Site Number : 1240209

    Toronto, Ontario, M2N 3A6

  • Investigational Site Number : 1240203

    Verdun, Quebec, H4G 2L8

Other trials in Canada

China5 sites

  • Investigational Site Number : 1560204

    Chongqing, 400038

  • Investigational Site Number : 1560206

    Guangzhou, 510000

  • Investigational Site Number : 1560201

    Guangzhou, 510018

  • Investigational Site Number : 1560202

    Guangzhou, 510120

  • Investigational Site Number : 1560203

    Wuhan, 430022

Other trials in China

Argentina4 sites

  • Investigational Site Number : 0320204

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320201

    Buenos Aires, 1427

  • Investigational Site Number : 0320203

    Córdoba, 5000

  • Investigational Site Number : 0320202

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

South Korea4 sites

  • Investigational Site Number : 4100202

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100203

    Bupyeong-gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100201

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100204

    Seoul, Seoul-teukbyeolsi, 03312

Other trials in South Korea

Spain4 sites

  • Investigational Site Number : 7240204

    Alicante, 03010

  • Investigational Site Number : 7240202

    Madrid, 28034

  • Investigational Site Number : 7240201

    Madrid, 28046

  • Investigational Site Number : 7240203

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

Czechia3 sites

  • Investigational Site Number : 2030201

    Prague, 110 01

  • Investigational Site Number : 2030202

    Prague, 160 00

  • Investigational Site Number : 2030203

    Prague, 180 81

Other trials in Czechia

Germany3 sites

  • Investigational Site Number : 2760201

    Berlin, 12203

  • Investigational Site Number : 2760205

    Hamburg, 20095

  • Investigational Site Number : 2760203

    Kiel, 24105

Other trials in Germany

Greece3 sites

  • Investigational Site Number : 3000203

    Athens, 142 33

  • Investigational Site Number : 3000201

    Athens, 161 21

  • Investigational Site Number : 3000202

    Ioannina, 455 00

Other trials in Greece

Mexico3 sites

  • Investigational Site Number : 4840201

    Guadalajara, Jalisco, 44657

  • Investigational Site Number : 4840203

    Mérida, Yucatán, 97070

  • Investigational Site Number : 4840202

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Taiwan3 sites

  • Investigational Site Number : 1580203

    Hsinchu, 300

  • Investigational Site Number : 1580202

    Taichung, 404

  • Investigational Site Number : 1580201

    Taoyuan City, 333

Other trials in Taiwan

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920202

    Gaziantep, 27310

  • Investigational Site Number : 7920201

    Istanbul, 34093

  • Investigational Site Number : 7920203

    Istanbul, 34722

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Investigational Site Number : 0560202

    Alken, 3570

  • Investigational Site Number : 0560203

    Maldegem, 9990

Other trials in Belgium

Chile2 sites

  • Investigational Site Number : 1520202

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520201

    Santiago, Reg Metropolitana de Santiago, 8380465

Other trials in Chile

Hungary2 sites

  • Investigational Site Number : 3480202

    Orosháza, 5900

  • Investigational Site Number : 3480201

    Pécs, 7632

Other trials in Hungary

Italy2 sites

  • Investigational Site Number : 3800201

    Naples, Napoli, 80131

  • Investigational Site Number : 3800202

    Rome, Roma, 00168

Other trials in Italy

United Kingdom1 site

  • Investigational Site Number : 8260201

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

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 NCT06687980
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 events (TEAEs) or serious adverse events (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 start25 Nov 2024
  3. Primary completion8 Jun 2026
  4. Study completion2 Sep 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
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687980
Sponsor's protocol ID
EFC18366
Other IDs
2024-514762-39, U1111-1310-5045
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, China, Argentina, South Korea 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 NCT06687980.

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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