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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ENV-294; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Operations; Email: env-294.clinicaltrials@enveda.com

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Enveda Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to participate in this study all participants must:

1. Be at least 18 years of age at the time of signing the ICF.
2. Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
3. Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months before Screening.

4. Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:

   1. A vIGA score of 3 (moderate) or 4 (severe)
   2. EASI score of ≥16
   3. Body surface area involvement of ≥10%
5. Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
6. Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
7. Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.

Exclusion Criteria:

Participants are excluded if they:

1. Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
2. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
3. Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by the investigator.
4. Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.
5. Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.
6. Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	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.
Experimental: ENV-294 Treatment Arm (Dose 1)	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.
Experimental: ENV-294 Treatment Arm (Dose 2)	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.
Experimental: ENV-294 Treatment Arm (Dose 3)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in Eczema Area and Severity Index (EASI) score	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vIGA Response	Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.	Baseline to Week 12
Incidence of Treatment Emergent Adverse Events		Baseline to Week 12 and Week 16
EASI-75 Response	Proportion of participants with at least 75% reduction from Baseline in EASI score	Baseline to Week 12
Percent change in Scoring Atopic Dermatitis (SCORAD)		Baseline to Week 12
Patient-Reported Outcomes	Change in Patient Oriented Eczema Measure (POEM)	Baseline to Week 12
Patient-Reported Outcomes	Peak Pruritus Numerical Rating Scale (PP-NRS): proportion of participants who achieve weekly mean decrease from Baseline of ≥4 points	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Enveda Therapeutics
• Investigators: Study Director: Gurpreet Ahluwalia, PhD, Enveda Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: ENV-294-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No