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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06058156
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : March 20, 2024
Sponsor:
Collaborator:
Kymera Therapeutics, Inc.
Information provided by (Responsible Party):
Sanofi

Brief 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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: SAR444656 (KT-474) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 9, 2023
Estimated Primary Completion Date : January 17, 2025
Estimated Study Completion Date : February 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: SAR444656 dose 1
Participants will receive SAR444656 dose 1 orally
Drug: SAR444656 (KT-474)
Oral Tablet

Experimental: SAR444656 dose 2
Participants will receive SAR444656 dose 2 orally
Drug: SAR444656 (KT-474)
Oral Tablet

Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. Percent change from baseline in EASI [ Time Frame: Week 16 ]
    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.


Secondary Outcome Measures :
  1. Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points [ Time Frame: Week 16 ]
  2. Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline) [ Time Frame: Week 16 ]
  3. Absolute change from baseline in EASI [ Time Frame: Week 16 ]
  4. Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline) [ Time Frame: Week 16 ]
  5. Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline) [ Time Frame: Week 16 ]
  6. Change from baseline in percent body surface area (BSA) affected by AD [ Time Frame: Week 16 ]
  7. Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline [ Time Frame: Week 16 ]
  8. Percent change from baseline in weekly average of daily PP-NRS [ Time Frame: Week 16 ]
  9. Absolute change from baseline in weekly average of daily PP-NRS [ Time Frame: Week 16 ]
  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 [ Time Frame: Up to Week 20 ]
  11. Plasma SAR444656 concentration [ Time Frame: Week 0, Week 1, Week 2, Week 4, and Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058156


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, Arizona
Clear Dermatology & Aesthetics Center Site Number: 8400003 Recruiting
Scottsdale, Arizona, United States, 85255-4140
United States, Florida
Encore Medical Research Site Number: 8400002 Recruiting
Boynton Beach, Florida, United States, 33436-7245
Encore Medical Research Site Number: 8400004 Recruiting
Hollywood, Florida, United States, 33021-6467
Encore Medical Research Site Number: 8400008 Recruiting
Weston, Florida, United States, 33331-3643
United States, Michigan
Revival Research Corporation Site Number: 8400007 Recruiting
Troy, Michigan, United States, 48084-3536
Germany
Investigational Site Number : 2760002 Recruiting
Buxtehude, Niedersachsen, Germany, 21614
Investigational Site Number : 2760003 Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44791
Investigational Site Number: 2760006 Recruiting
Remscheid, Nordrhein-Westfalen, Germany, 42897
Greece
Investigational Site Number : 3000001 Recruiting
Pavlos Melas, Thessaloniki, Greece, 564 29
Investigational Site Number : 3000002 Recruiting
Thessaloniki, Greece, 546 43
Poland
Investigational Site Number : 6160002 Recruiting
Wroclaw, Dolnośląskie, Poland, 50-566
Investigational Site Number : 6160001 Recruiting
Lódz, Lódzkie, Poland, 90-436
Investigational Site Number : 6160007 Recruiting
Warszawa, Mazowieckie, Poland, 00-874
Investigational Site Number: 6160005 Recruiting
Warszawa, Mazowieckie, Poland, 02-953
Investigational Site Number: 6160003 Recruiting
Chojnice, Pomorskie, Poland, 89-600
Investigational Site Number: 6160004 Recruiting
Gdansk, Pomorskie, Poland, 80-546
Sponsors and Collaborators
Sanofi
Kymera Therapeutics, Inc.
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT06058156    
Other Study ID Numbers: ACT17754
2023-504346-66 ( Registry Identifier: CTIS )
U1111-1287-6919 ( Registry Identifier: ICTRP )
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases