Phase 2 study of SAR444656 in adult participants with moderate to severe atopic dermatitis.

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] - Skin and Connective Tissue Diseases [C17]

Trial duration

14 Feb 2024 → 21 Nov 2025

Decision date (initial)

2025-04-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Développement

External identifiers

EU CT number

2023-504346-66-00

WHO UTN

U1111-1287-6919

ClinicalTrials.gov

NCT06058156

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Therapy, Efficacy, Pharmacogenomic, Pharmacokinetic, Pharmacodynamic

To assess the efficacy of SAR444656 on AD lesions compared with placebo in adult participants with moderate to severe AD.

Secondary objectives 4

1. To assess the efficacy of SAR444656 on additional clinical assessments of AD compared with placebo in adult participants with moderate to severe AD.
2. To assess the efficacy of SAR444656 on patients reported outcomes (PRO) compared with placebo in adult participants with moderate to severe AD.
3. To assess the safety of SAR444656 in adult participants with moderate to severe AD.
4. To assess the pharmacokinetic profile of SAR444656 in adult participants with moderate to severe AD.

Conditions and MedDRA coding

Dermatitis atopic

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participants with atopic dermatitis as defined by the American Academy of Dermatology Consensus Criteria for at least 1 year before the baseline visit.
2. EASI ≥12 at screening and at baseline visit.
3. vIGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visit.
4. AD involvement ≥10% of BSA at screening and baseline visit.
5. Baseline PP-NRS ≥4.
6. Participants must have documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications.
7. Participants must have applied daily topical emollient (moisturizer) for at least the 7 consecutive days immediately before the baseline visit. Participants should continue using daily moisturizers during the study.
8. Participants must be willing and able to complete the electronic diary for the duration of the study as required by the study protocol.
9. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria 14

1. Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus.
2. History of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
3. History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
4. Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hg or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication
5. Participants had major surgery within 4 weeks prior to the screening or have planned any elective major surgery during the study.
6. Any active or chronic infection requiring systemic treatment within 4 weeks prior to baseline.
7. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
8. History of solid organ or stem cell transplant.
9. Participants with history of splenectomy.
10. Participants with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
11. Family history of sudden death or long QT syndrome.
12. History of congenital or drug-induced long QT syndrome.
13. Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
14. Having received any of protocol-specified prohibited therapy (topical or systemic) within the specified timeframe prior to the baseline visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in EASI.

Secondary endpoints 11

1. Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points
2. Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline).
3. Absolute change from baseline in EASI.
4. Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline).
5. Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline).
6. Change from baseline in percent body surface area (BSA) affected by AD
7. Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline
8. Percent change from baseline in weekly average of daily PP-NRS.
9. Absolute change from baseline in weekly average of daily PP-NRS.
10. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs
11. Plasma SAR444656 concentration.

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 Research & Development

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Third parties 7

Locations

4 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

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

Documents 79 files

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

Application history

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