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

NCT07643766 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ENV-294-202
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent change in Eczema Area and Severity Index (EASI) score

  Baseline to Week 12

Secondary Outcomes (6)

• Incidence of Treatment Emergent Adverse Events

  Baseline to Week 12 and Week 16

• EASI-75 Response

  Baseline to Week 12

• vIGA Response

  Baseline to Week 12

• Percent change in Scoring Atopic Dermatitis (SCORAD)

  Baseline to Week 12

• Patient-Reported Outcomes

  Baseline to Week 12

Study Arms (4)

ENV-294 Treatment Arm (Dose 1)

EXPERIMENTAL

Drug: ENV-294

ENV-294 Treatment Arm (Dose 2)

EXPERIMENTAL

Drug: ENV-294

ENV-294 Treatment Arm (Dose 3)

EXPERIMENTAL

Drug: ENV-294

Placebo Arm

PLACEBO COMPARATOR

Other: Placebo

Interventions

ENV-294 DRUG

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

ENV-294 Treatment Arm (Dose 1); ENV-294 Treatment Arm (Dose 2); ENV-294 Treatment Arm (Dose 3)

Placebo OTHER

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.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to participate in this study all participants must:
• Be at least 18 years of age at the time of signing the ICF.
• Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
• 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.
• Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:
• A vIGA score of 3 (moderate) or 4 (severe)
• EASI score of ≥16
• Body surface area involvement of ≥10%
• Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
• 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.
• Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.

You may not qualify if:

• Participants are excluded if they:
• 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.
• Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
• 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.
• 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.
• 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.
• Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.

Sponsors & Collaborators

• Enveda Therapeutics: lead

Study Sites (1)

Enveda Investigative Site

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gurpreet Ahluwalia, PhD

  Enveda Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations

CONTACT

env-294.clinicaltrials@enveda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)