A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07643766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-06

No results posted yet for this study

Summary

This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.

Conditions

Interventions

DRUG

ENV-294

ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.

OTHER

Placebo

Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Sponsors & Collaborators

  • Enveda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Gurpreet Ahluwalia, PhD · Enveda Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2027-12-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT07643766 on ClinicalTrials.gov