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)

JRCT ID: jRCT2031240549

Registered date:13/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lichen Simplex Chronicus
• Date of first enrollment: 25/12/2024
• Target sample size: 136
• Countries of recruitment: TBD,Japan
• Study type: Interventional

Intervention(s)

Drug: Dupilumab (SAR231893, Dupixent)
Pharmaceutical form: Solution for injection
Route of administration: subcutaneous injection
Drug: Placebo
Pharmaceutical form: Solution for injection
Route of administration: subcutaneous injection

Study Arms:
- Experimental: Dupilumab
Dupilumab subcutaneous injection as per protocol
Drug: Dupilumab
- Placebo Comparator: Placebo
Placebo subcutaneous injection as per protocol
Drug: Placebo

Outcome(s)

Primary Outcome

1. Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >=4 from baseline to Week 24
[Time frame: Week 24]
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").

Secondary Outcome

1. Change in weekly average of daily WI-NRS from baseline to Week 24
[Time frame: 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").
2. Change in weekly average of daily Itch-related Sleep Disturbance numerical rating scale (NRS) from baseline to Week 24
[Time frame: 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").
3. Change in Itchy quality of life survey (ItchyQoL) score from baseline to Week 24
[Time frame: Baseline to Week 24]
ItchyQoL is a pruritus-specific quality of life (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.
4. Change in Dermatology life quality index (DLQI) total score from baseline to Week 24
[Time frame: Baseline to Week 24]
DLQI is a validated 10-item questionnaire to measure dermatology-specific QoL in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer health-related QoL.
5. Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >=4 from baseline to Week 12
[Time frame: 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").
6. Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab
[Time frame: Baseline through Week 36]
7. Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
[Time frame: Baseline through Week 36]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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) (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.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT06687967,2024-514737-37-00