DUPILUMAB for Lichen simplex chronicus (LSC)|Neurodermatitis

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- History of LSC for at least 6 months prior to the screening visit."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Appropriate contraceptive measures"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study."}
• {"criterion_text":"- Severe psychiatric disease that, in the Investigator’s judgement, would affect the study intervention evaluation."}
• {"criterion_text":"- Having received or planning to use any of the treatments within the timeframe as specified in the protocol."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24","definition_or_measurement_approach":"Weekly average of daily Worst-Itch Numerical Rating Scale (WI-NRS, 0-10); improvement defined as reduction ≥4 from baseline to Week 24. (Baseline WI-NRS average requires at least 4 daily scores out of the 7 days prior to Day 1.)"}

Secondary endpoints

• {"endpoint_text":"- Change in weekly average of daily WI-NRS from baseline to Week 24","definition_or_measurement_approach":"Absolute change in weekly average of daily WI-NRS from baseline to Week 24."}
• {"endpoint_text":"- Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24","definition_or_measurement_approach":"Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24."}
• {"endpoint_text":"- Change in ItchyQoL score from baseline to Week 24","definition_or_measurement_approach":"Absolute change in ItchyQoL score from baseline to Week 24."}
• {"endpoint_text":"- Change in DLQI total score from baseline to Week 24","definition_or_measurement_approach":"Absolute change in Dermatology Life Quality Index (DLQI) total score from baseline to Week 24."}
• {"endpoint_text":"- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12","definition_or_measurement_approach":"Proportion achieving ≥4 reduction in weekly average of daily WI-NRS from baseline to Week 12."}
• {"endpoint_text":"- Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies (ADA) against dupilumab reported during the treatment period."}
• {"endpoint_text":"- Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)","definition_or_measurement_approach":"Percentage of participants experiencing TEAEs or SAEs during the study treatment period as reported."}
• {"endpoint_text":"- Percentage change in weekly average of daily WI-NRS from baseline to Week 24","definition_or_measurement_approach":"Percentage change in weekly average of daily WI-NRS from baseline to Week 24."}
• {"endpoint_text":"- Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24","definition_or_measurement_approach":"Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24."}
• {"endpoint_text":"- Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24","definition_or_measurement_approach":"Proportion of participants achieving Investigator's Global Assessment (IGA) score of 0 or 1 for LSC at Week 12 and at Week 24."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants meeting both criteria: ≥4 reduction in weekly average WI-NRS from baseline to Week 24 AND IGA score of 0 or 1 for LSC at Week 24."}

Methods

• Recruitment materials: poster (K2-recruitment-material-poster), flyer (K2-recruitment-material-flyer), patient letter (K2-recruitment-material-patient-letter), doctor-to-doctor materials (K2-recruitment-material-dr-to-dr); recruitment arrangements (K1-recruitment-arrangements). Documents available in multiple language versions (en, de, el, hu, it, es, fr, nl, cs) associated with Member States' part II submissions.

Belgium

Earliest CTIS Part Ii Submission Date

08-01-2025

Latest Decision Or Authorization Date

23-05-2025

Processing Time Days

135

Number Of Sites

2

Number Of Participants

3

Czechia

Earliest CTIS Part Ii Submission Date

08-01-2025

Latest Decision Or Authorization Date

05-02-2025

Processing Time Days

28

Number Of Sites

3

Number Of Participants

11

Germany

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

06-02-2025

Processing Time Days

80

Number Of Sites

4

Number Of Participants

11

Greece

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

117

Number Of Sites

3

Number Of Participants

16

Hungary

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

75

Number Of Sites

2

Number Of Participants

4

Italy

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

55

Number Of Sites

2

Number Of Participants

7

Spain

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

07-02-2025

Processing Time Days

120

Number Of Sites

4

Number Of Participants

17

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Parexel International Services India Private Limited

Responsibilities

sponsorDuties codes: 8

Name

PPD International Holdings LLC

Responsibilities

Sample management (testing/storage)

Name

Endpoint Clinical Inc.

Responsibilities

sponsorDuties codes: 3

Name

Eresearchtechnology Inc.

Responsibilities

Clinical Outcomes Assessment Instrument (eCOA)

Name

ESMS Global Limited

Responsibilities

Centralized 24-Hour Emergency System: eSMS

Name

Marken

Responsibilities

sponsorDuties codes: 14 (logistics-related role shown)

Name

Azenta Germany GmbH

Responsibilities

Sample long-term storage

Third parties

• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Clinical Outcomes Assessment Instrument (eCOA) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Marken","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample long-term storage (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Sample management (testing/storage) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}