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
142
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Dermatology Research Associates - Los Angeles- Site Number : 8400004
Los Angeles, California, United States
Quality Care Clinical Research- Site Number : 8400034
Miami, Florida, United States
Michigan Center for Research Company- Site Number : 8400013
Clarkston, Michigan, United States
JDR Dermatology Research- Site Number : 8400023
Las Vegas, Nevada, United States
Equity Medical- Site Number : 8400017
New York, New York, 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 event (TEAEs) or serious adverse event (SAEs)
Time frame: Baseline through Week 36
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Onsite Clinical Solutions - Huntersville- Site Number : 8400033
Huntersville, North Carolina, United States
Wake Forest University Health Sciences- Site Number : 8400028
Winston-Salem, North Carolina, United States
Red River Research Partners - Fargo- Site Number : 8400007
Fargo, North Dakota, United States
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011
Houston, Texas, United States
MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014
Houston, Texas, United States
...and 53 more locations