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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Cosmetic Dermatology of Orange County- Site Number : 8400232
Anaheim, California, United States
Center for Dermatology Clinical Research- Site Number : 8400226
Fremont, California, United States
University of Miami Miller School of Medicine- Site Number : 8400218
Miami, Florida, United States
TrueBlue Clinical Research- Site Number : 8400208
Tampa, Florida, United States
Skin Care Physicians of Georgia - Macon- Site Number : 8400236
Macon, Georgia, United States
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").
Time frame: Week 24
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").
Time frame: Baseline to Week 24
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").
Time frame: Baseline to Week 24
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").
Time frame: Baseline to Week 24
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").
Time frame: Baseline to Week 24
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
Time frame: Baseline to Week 24
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.
Time frame: Baseline to Week 24
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").
Time frame: Week 12
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).
Time frame: Week 12 and 24
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).
Time frame: Baseline through Week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab
Time frame: Baseline through Week 36
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time frame: Baseline through Week 36
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Southern Indiana Clinical Research Center- Site Number : 8400230
Columbus, Indiana, United States
Equity Medical - Bowling Green- Site Number : 8400240
Bowling Green, Kentucky, United States
Brigham & Women's Hospital- Site Number : 8400229
Boston, Massachusetts, United States
Clinical Research of Philadelphia- Site Number : 8400215
Philadelphia, Pennsylvania, United States
Bellaire Dermatology Associates,- Site Number : 8400202
Bellaire, Texas, United States
...and 53 more locations