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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

3 Mar 2025 → ongoing

Decision date (initial)

2025-02-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-514762-39-00

WHO UTN

U1111-1310-5045

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

• To demonstrate the efficacy of dupilumab on pruritus of LSC in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies

Secondary objectives 7

1. • To demonstrate the efficacy of dupilumab on an additional pruritus of LSC endpoints in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies
2. • To demonstrate the efficacy of dupilumab in decreasing itch-related sleep disturbance
3. • To demonstrate the improvement in HRQoL
4. • To evaluate the immunogenicity of dupilumab
5. • To evaluate safety outcome measures
6. To evaluate the efficacy of dupilumab on LSC lesions in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies
7. To evaluate the efficacy of dupilumab on both pruritus of LSC and LSC lesions in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies

Conditions and MedDRA coding

Neurodermatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. 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).
3. History of LSC for at least 6 months prior to the screening visit.
4. 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.
5. 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.
6. Appropriate contraceptive measures

Exclusion criteria 5

1. 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.
2. 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.
3. Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study.
4. Severe psychiatric disease that, in the Investigator’s judgement, would affect the study intervention evaluation.
5. Having received or planning to use any of the treatments within the timeframe as specified in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24

Secondary endpoints 11

1. Change in weekly average of daily WI-NRS from baseline to Week 24
2. Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
3. Change in ItchyQoL score from baseline to Week 24
4. Change in DLQI total score from baseline to Week 24
5. Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
6. Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab
7. Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
8. Percentage change in weekly average of daily WI-NRS from baseline to Week 24
9. Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
10. Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24
11. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 12

Locations

7 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 68 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications