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Phase 2 study of SAR444656 in adult participants with moderate to severe atopic dermatitis.
EU CTIS ID: 2023-504346-66-00
What this study is testing
To assess the efficacy of SAR444656 on AD lesions compared with placebo in adult participants with moderate to severe AD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus.
- 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.
- Having received any of protocol-specified prohibited therapy (topical or systemic) within the specified timeframe prior to the baseline visit
See the full eligibility 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.
- 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.
- Having received any of protocol-specified prohibited therapy (topical or systemic) within the specified timeframe prior to the baseline visit
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Canada
- Japan
- Korea, Republic of
- Taiwan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Canada; Japan; Korea, Republic of; Taiwan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.