Clinical trial NCT06687980: 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)
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 events (TEAEs) or serious adverse events (SAEs)
timeFrame: Baseline through Week 36
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8400226
state: California
city: Tampa
country: United States
facility: TrueBlue Clinical Research- Site Number : 8400208
state: Florida
city: Columbus
country: United States
facility: Southern Indiana Clinical Research Center- Site Number : 8400230
state: Indiana
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia- Site Number : 8400215
state: Pennsylvania
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio- Site Number : 8400206
state: Texas
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320202
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320201
city: Córdoba
country: Argentina
facility: Investigational Site Number : 0320203
city: Alken
country: Belgium
facility: Investigational Site Number : 0560202
city: Calgary
country: Canada
facility: Investigational Site Number : 1240210
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240207
state: Alberta
city: Surrey
country: Canada
facility: Investigational Site Number : 1240201
state: British Columbia
city: London
country: Canada
facility: Investigational Site Number : 1240205
state: Ontario
city: Markham
country: Canada
facility: Investigational Site Number : 1240208
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240209
state: Ontario
city: Verdun
country: Canada
facility: Investigational Site Number : 1240203
state: Quebec
city: Santiago
country: Chile
facility: Investigational Site Number : 1520202
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520201
state: Reg Metropolitana De Santiago
city: Chongqing
country: China
facility: Investigational Site Number : 1560204
city: Guangzhou
country: China
facility: Investigational Site Number : 1560206
city: Guangzhou
country: China
facility: Investigational Site Number : 1560201
city: Guangzhou
country: China
facility: Investigational Site Number : 1560202
city: Wuhan
country: China
facility: Investigational Site Number : 1560203
city: Prague
country: Czechia
facility: Investigational Site Number : 2030201
city: Prague
country: Czechia
facility: Investigational Site Number : 2030202
city: Prague
country: Czechia
facility: Investigational Site Number : 2030203
city: Berlin
country: Germany
facility: Investigational Site Number : 2760201
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760205
city: Kiel
country: Germany
facility: Investigational Site Number : 2760203
city: Athens
country: Greece
facility: Investigational Site Number : 3000203
city: Athens
country: Greece
facility: Investigational Site Number : 3000201
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000202
city: Orosháza
country: Hungary
facility: Investigational Site Number : 3480202
city: Pecs
country: Hungary
facility: Investigational Site Number : 3480201
city: Naples
country: Italy
facility: Investigational Site Number : 3800201
state: Napoli
city: Rome
country: Italy
facility: Investigational Site Number : 3800202
state: Roma
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100202
state: Gyeonggi-do
city: Bupyeong-gu
country: Korea, Republic of
facility: Investigational Site Number : 4100203
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100201
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100204
state: Seoul-teukbyeolsi
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240203
state: Madrid
city: Alicante
country: Spain
facility: Investigational Site Number : 7240204
city: Madrid
country: Spain
facility: Investigational Site Number : 7240202
city: Madrid
country: Spain
facility: Investigational Site Number : 7240201
city: Taoyuan City
country: Taiwan
facility: Investigational Site Number : 1580201
city: Gaziantep
country: Turkey
facility: Investigational Site Number : 7920202
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920201
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920203
city: Southampton
country: United Kingdom
facility: Investigational Site Number : 8260201
state: Hampshire
Study officials:
References: