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

NCT06058156 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-11

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

SAR444656 (KT-474)

Oral Tablet

DRUG

Placebo

Oral Tablet

Sponsors & Collaborators

  • Sanofi

    lead INDUSTRY

  • Kymera Therapeutics, Inc.

    collaborator INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2025-10-23
Completion
2025-11-20
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Greece
  • Poland
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058156 on ClinicalTrials.gov