Clinical trial NCT06687967: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lichen Simplex Chronicus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-11-14
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change in weekly average of daily WI-NRS from baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in ItchyQoL score from baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in DLQI total score from baseline to Week 24
timeFrame: Baseline to Week 24
measure: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
timeFrame: Week 12
measure: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab
timeFrame: Baseline through Week 36
measure: Percentage of participants experiencing treatment-emergent adverse event (TEAEs) or serious adverse event (SAEs)
timeFrame: Baseline through Week 36
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles- Site Number : 8400004
state: California
city: Clarkston
country: United States
facility: Michigan Center for Research Company- Site Number : 8400013
state: Michigan
city: New York
country: United States
facility: Equity Medical- Site Number : 8400017
state: New York
city: Fargo
country: United States
facility: Red River Research Partners- Site Number : 8400007
state: North Dakota
city: Houston
country: United States
facility: MedCare Pharma- Site Number : 8400014
state: Texas
city: Arlington
country: United States
facility: Care Access - Arlington 2- Site Number : 8400022
state: Virginia
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320002
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240005
state: Alberta
city: London
country: Canada
facility: Investigational Site Number : 1240001
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site Number : 1240007
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240009
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240008
state: Quebec
city: Regina
country: Canada
facility: Investigational Site Number : 1240010
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240002
state: Saskatchewan
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Beijing
country: China
facility: Investigational Site Number : 1560002
city: Hangzhou
country: China
facility: Investigational Site Number : 1560004
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Shijiazhuang
country: China
facility: Investigational Site Number : 1560003
city: Suzhou
country: China
facility: Investigational Site Number : 1560005
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030001
city: Bad Bentheim
country: Germany
facility: Investigational Site Number : 2760003
city: Magdeburg
country: Germany
facility: Investigational Site Number : 2760001
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3480001
city: Kaposvár
country: Hungary
facility: Investigational Site Number : 3480002
city: Rome
country: Italy
facility: Investigational Site Number : 3800001
state: Roma
city: Bologna
country: Italy
facility: Investigational Site Number : 3800002
city: Nishi-ku
country: Japan
facility: Investigational Site Number : 3920009
state: Fukuoka
city: Ebina-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Kanagawa
city: Kamiamakusa
country: Japan
facility: Investigational Site Number : 3920001
state: Kumamoto
city: Sakai
country: Japan
facility: Investigational Site Number : 3920007
state: Osaka
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920003
state: Tokyo
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3920005
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200003
city: Porto
country: Portugal
facility: Investigational Site Number : 6200001
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240003
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240005
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240002
state: Catalunya [Cataluña]
city: Valencia
country: Spain
facility: Investigational Site Number : 7240004
city: Adapazari
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920001
city: Milton Keynes
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Buckinghamshire
city: London
country: United Kingdom
facility: Investigational Site Number : 8260001
state: England
Study officials:
References: