Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ADVANTA  

Official title:

A Multinational, Multicenter, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058156
• Other study ID #: ACT17754
• Secondary ID: 2023-504346-66U1
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2023
• Est. completion date: February 14, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 3-arm study in adult participants with moderate to severe AD who are inadequately controlled with topical therapies or for whom such topical therapies are inadvisable and who are candidates for systemic therapy.

Participants will be randomized to receive SAR444656 dose 1, SAR444656 dose 2 or matching placebo.

Participants who meet inclusion/exclusion criteria will be stratified for randomization by severity of AD (moderate [baseline EASI score <22] versus severe [baseline EASI score ≥22]).

The total duration of study is approximately 24 weeks, including 1 to 4 weeks for screening, 16 weeks for double-blind study treatment and 4 weeks for follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: February 14, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with atopic dermatitis as defined by the American Academy of Dermatology Consensus Criteria for at least 1 year before the baseline visit.

• EASI =12 at screening and at baseline visit

• vIGA score =3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visit.

• AD involvement =10% of BSA at screening and baseline visit

• Baseline PP-NRS =4

• Participants must have documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications

• 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.

• Participants must be willing and able to complete the electronic diary for the duration of the study as required by the study protocol.

• 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:

• Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus

• Any active or chronic infection requiring systemic treatment within 4 weeks prior to baseline

• 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.

• History of solid organ or stem cell transplant.

• Participants with history of splenectomy.

• 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.

• Family history of sudden death or long QT syndrome.

• History of congenital or drug-induced long QT syndrome.

• Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.

• 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.

• History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.

• Uncontrolled hypertension defined as consistent systolic blood pressure =150 mm Hg or consistent diastolic blood pressure =90 mm Hg despite antihypertensive medication.

• Participants had major surgery within 4 weeks prior to the screening or have planned any elective major surgery during the study.

• Having received any of protocol-specified prohibited therapy (Topical or systemic) within the specified timeframe prior to the baseline visit.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• SAR444656 (KT-474)
Oral Tablet
• Placebo
Oral Tablet

Locations

Country	Name	City	State
Germany	Investigational Site Number : 2760001	Berlin
Germany	Investigational Site Number : 2760003	Bochum	Nordrhein-Westfalen
Germany	Investigational Site Number : 2760002	Buxtehude	Niedersachsen
Germany	Investigational Site Number : 2760010	Dessau-Roßlau	Sachsen-Anhalt
Germany	Investigational Site Number : 2760008	Frankfurt am Main	Hessen
Germany	Investigational Site Number : 2760007	Heidelberg	Baden-Württemberg
Germany	Investigational Site Number : 2760009	München	Bayern
Germany	Investigational Site Number: 2760006	Remscheid	Nordrhein-Westfalen
Greece	Investigational Site Number : 3000001	Pavlos Melas	Thessaloniki
Greece	Investigational Site Number : 3000002	Thessaloniki
Poland	Investigational Site Number: 6160003	Chojnice	Pomorskie
Poland	Investigational Site Number: 6160004	Gdansk	Pomorskie
Poland	Investigational Site Number : 6160001	Lódz	Lódzkie
Poland	Investigational Site Number : 6160006	Tarnów	Malopolskie
Poland	Investigational Site Number : 6160007	Warszawa	Mazowieckie
Poland	Investigational Site Number: 6160005	Warszawa	Mazowieckie
Poland	Investigational Site Number : 6160002	Wroclaw	Dolnoslaskie
United States	Encore Medical Research Site Number: 8400002	Boynton Beach	Florida
United States	Encore Medical Research Site Number: 8400004	Hollywood	Florida
United States	Tory Sullivan, MD, PA Site Number: 8400001	North Miami Beach	Florida
United States	Clear Dermatology & Aesthetics Center Site Number: 8400003	Scottsdale	Arizona
United States	Revival Research Corporation Site Number: 8400007	Troy	Michigan
United States	Encore Medical Research Site Number: 8400008	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Kymera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in EASI	Eczema area severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Week 16
Secondary	Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of =2 points		Week 16
Secondary	Proportion of participants achieving EASI-75 (reduction of EASI score by =75% from baseline)		Week 16
Secondary	Absolute change from baseline in EASI		Week 16
Secondary	Proportion of participants achieving EASI-50 (reduction of EASI score by =50% from baseline)		Week 16
Secondary	Proportion of participants achieving EASI-90 (reduction of EASI score by =90% from baseline)		Week 16
Secondary	Change from baseline in percent body surface area (BSA) affected by AD		Week 16
Secondary	Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by =4 points from baseline		Week 16
Secondary	Percent change from baseline in weekly average of daily PP-NRS		Week 16
Secondary	Absolute change from baseline in weekly average of daily PP-NRS		Week 16
Secondary	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		Up to Week 20
Secondary	Plasma SAR444656 concentration		Week 0, Week 1, Week 2, Week 4, and Week 16