Status:
TERMINATED
Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Kymera Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 topica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06058156
Start Date
November 9 2023
End Date
November 20 2025
Last Update
December 11 2025
Active Locations (37)
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1
Clear Dermatology & Aesthetics Center- Site Number : 8400003
Scottsdale, Arizona, United States, 85255
2
Encore Medical Research of Boynton Beach- Site Number : 8400002
Boynton Beach, Florida, United States, 33436
3
Revival Research - Doral- Site Number : 8400007
Doral, Florida, United States, 33122
4
Encore Medical Research - 6600 Taft St- Site Number : 8400004
Hollywood, Florida, United States, 33024