Undersøgelse af ENV-294 hos voksne med moderat til svær atopisk dermatitis
En fase 2, randomiseret, dobbeltblind, placebo-kontrolleret, parallelgruppe, 12-ugers undersøgelse for at evaluere effektiviteten, sikkerheden og farmakokinetikken af ENV 294 hos voksne deltagere med moderat til svær atopisk dermatitis
The goal of this clinical trial is to learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis.
The main questions it will answer are:
- Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294
- What medical problems do participants have when taking ENV-294
Participants will:
- Take drug ENV-294 or a placebo once every day for 12 weeks
- Visit the clinic every 2 to 4 weeks for checkups and tests
- Keep a diary of their symptoms and when they took their study drug
- Return to the clinic for the final study visit at approximately week 16
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Operations
- E-mail: env-294.clinicaltrials@enveda.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35244
- Rekruttering
- Enveda Investigative Site
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Arkansas
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Hot Springs, Arkansas, Forenede Stater, 71913
- Rekruttering
- Enveda Investigative Site
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California
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Beverly Hills, California, Forenede Stater, 90212
- Rekruttering
- Enveda Investigative Site
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Fremont, California, Forenede Stater, 94538
- Rekruttering
- Enveda Investigative Site
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San Diego, California, Forenede Stater, 92121
- Rekruttering
- Enveda Investigative Site
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- Enveda Investigative Site
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Santa Monica, California, Forenede Stater, 90403
- Rekruttering
- Enveda Investigative Site
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West Hills, California, Forenede Stater, 91307
- Rekruttering
- Enveda Investigative Site
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Enveda Investigative Site
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Miami, Florida, Forenede Stater, 33175
- Rekruttering
- Enveda Investigative Site
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Miramar, Florida, Forenede Stater, 33027
- Rekruttering
- Enveda Investigative Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30327
- Rekruttering
- Enveda Investigative Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60657
- Rekruttering
- Enveda Investigative Site
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Indiana
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Clarksville, Indiana, Forenede Stater, 47129
- Rekruttering
- Enveda Investigative Site
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New Albany, Indiana, Forenede Stater, 47150
- Rekruttering
- Enveda Investigative Site
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West Lafayette, Indiana, Forenede Stater, 47906
- Rekruttering
- Enveda Investigative Site
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40217
- Rekruttering
- Enveda Investigative Site
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Louisville, Kentucky, Forenede Stater, 40241
- Rekruttering
- Enveda Investigative Site
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Michigan
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Auburn Hills, Michigan, Forenede Stater, 48326
- Rekruttering
- Enveda Investigative Site
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Bay City, Michigan, Forenede Stater, 48706
- Rekruttering
- Enveda Investigative Site
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Clinton Township, Michigan, Forenede Stater, 48038
- Rekruttering
- Enveda Investigative Site
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Warren, Michigan, Forenede Stater, 48088
- Rekruttering
- Enveda Investigative Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89145
- Rekruttering
- Enveda Investigative Site
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New York
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Enveda Investigative Site
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28405
- Rekruttering
- Enveda Investigative Site
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Rekruttering
- Enveda Investigative Site
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Rekruttering
- Enveda Investigative Site
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Pennsylvania
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Camp Hill, Pennsylvania, Forenede Stater, 17011
- Rekruttering
- Enveda Investigative Site
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Texas
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Arlington, Texas, Forenede Stater, 76011
- Rekruttering
- Enveda Investigative Site
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Houston, Texas, Forenede Stater, 77004
- Rekruttering
- Enveda Investigative Site
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San Antonio, Texas, Forenede Stater, 78218
- Rekruttering
- Enveda Investigative Site
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Enveda Investigative Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
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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
- BSA ≥10%
- PP-NRS score of ≥4
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Have had either a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months
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Use a bland moisturizer at least daily
Exclusion Criteria:
- Current or recurrent medical conditions that could affect the study drug or study assessments
- Any illness that could impact participant safety or active infections
- Ongoing skin condition or large tattoos that would interfere with clinical assessment
- Clinically significant skin infection requiring treatment
- Clinically significant abnormal laboratory assessments at screening
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm. |
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks. |
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Placebo komparator: Placebo Arm
A placebo will be administered to those participants randomized to the placebo arm. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
Tidsramme: Baseline to Week 12
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The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease. |
Baseline to Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence and Severity of Adverse Events
Tidsramme: Baseline to Week 12
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Number and seriousness of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug. |
Baseline to Week 12
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EASI-75 Response
Tidsramme: Baseline to Week 12
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Percentage of participants with at least 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score. |
Baseline to Week 12
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vIGA Response
Tidsramme: Baseline to Week 12
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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
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Patient-Reported Outcomes
Tidsramme: Baseline to Week 12
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Change and percent change in Peak Pruritus Numerical Rating Scale (PP-NRS). |
Baseline to Week 12
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Patient-Reported Outcomes
Tidsramme: Baseline to Week 12
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Change and percent change in Patient Oriented Eczema Measure (POEM). |
Baseline to Week 12
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Pharmacokinetics of ENV-294
Tidsramme: Baseline to Week 12
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Observed concentration values of ENV-294 at the times blood samples are collected. |
Baseline to Week 12
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Gurpreet Ahluwalia, PhD, Enveda Therapeutics, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENV-294-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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