TERMINATED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-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, dose 2, dose 3 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.

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

Quick Facts

Study Start:2023-11-09

Study Completion:2025-11-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06058156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Clear Dermatology & Aesthetics Center- Site Number : 8400003

Scottsdale, Arizona, 85255

United States

Encore Medical Research of Boynton Beach- Site Number : 8400002

Boynton Beach, Florida, 33436

United States

Revival Research - Doral- Site Number : 8400007

Doral, Florida, 33122

United States

Encore Medical Research - 6600 Taft St- Site Number : 8400004

Hollywood, Florida, 33024

United States

Sullivan Dermatology- Site Number : 8400001

Miami, Florida, 33162

United States

ARA Professionals- Site Number : 8400017

Miami, Florida, 33176-1032

United States

Encore Medical Research - Weston- Site Number : 8400008

Weston, Florida, 33331

United States

Wayne Health - Dearborn- Site Number : 8400009

Dearborn, Michigan, 48126

United States

UPMC Montefiore- Site Number : 8400006

Pittsburgh, Pennsylvania, 15213

United States

ACRC Trials - Carrollton - Hunt - PPDS- Site Number : 8400012

Carrollton, Texas, 75010-4632

United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09

Study Completion Date2025-11-20

Study Record Updates

Study Start Date2023-11-09

Study Completion Date2025-11-20

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis