A study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Cracow, Gdansk, Lublin, Piotrkow Trybunalski, Sosnowiec, Warsaw és Wroclaw, LengyelországSee the 12 sites
- Phase
- 2. fázis
Where in Lengyelország
- Centrum Medyczne All-Med Badania KliniczneCracow, LengyelországToborzás még nem indult
- Pratia S.A.Cracow, LengyelországToborzás még nem indult
- Penta Hospitals Badania Kliniczne sp. z o.o.Gdansk, LengyelországToborzás még nem indult
- Luxderm Specjalistyczny Gabinet DermatologicznyLublin, LengyelországToborzás még nem indult
- Hipokrates Centrum Medyczne Sp. z o.o.Piotrkow Trybunalski, LengyelországToborzás még nem indult
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o oSosnowiec, LengyelországToborzás még nem indult
- Klinika Ambroziak Sp. z o.o.Warsaw, LengyelországToborzás még nem indult
- Therapia Nova Sp z o.oWarsaw, LengyelországToborzás még nem indult
- dermMedica Sp. z o.oWroclaw, LengyelországToborzás még nem indult
- Medicus Sp. z o.o.Wroclaw, LengyelországToborzás még nem indult
- Synexus Polska Sp. z o.o.Wroclaw, LengyelországToborzás még nem indult
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Enveda Therapeutics Inc.
- Trial code
- EU 2026-526184-38-00
- Record updated
- 2026. szeptember 28.
- Original description
To evaluate the efficacy of ENV-294 doses compared with placebo on severity and extent of atopic dermatitis (AD).Read full original descriptionShow less
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
To evaluate the efficacy of ENV-294 doses compared with placebo on severity and extent of atopic dermatitis (AD).
Inclusion: 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 and meets Hanifin and Rajka criteria (Hanifin et al, 1980) for AD and had no clinically significant flares for at least 4 weeks before Screening as assessed by the Investigator. 3. Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD as determined by the Investigator 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: a. A vIGA-AD score of 3 (moderate) or 4 (severe) b. EASI score of ≥16 c. Body surface area involvement of ≥10% (excluding scalp and groin area) 5. Have PP-NRS score ≥4 at Screening and Baseline (note: the Baseline score refers to a weekly average of daily assessments and the participants must complete at least 4 of the 7 daily assessments in the Week prior to Day 1); Use a bland emollient without ingredients that could potentially impact clinical scores (ie, urea) 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.
Exclusion: 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. In addition, they will be excluded if they are positive for human immunodeficiency virus [HIV], hepatitis B surface antigen [HBsAg], or hepatitis C virus [HCV]. 2. Have a history of suicidal ideation with actual intent and a specific plan within the past year, as indicated by a 'Yes' response to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS); or have answered 'Yes' to any suicidal behavior item on the C-SSRS within the past 5 years. 3. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of study results. 4. 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. 5. 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.