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L'essai clinique NCT04773600 pour Eczéma de dermatite atopique est terminé. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Arcutis BiotherapeuticsTrial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) Phase III 683 Double aveugle
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04773600 était conçu pour étudier le traitement de Eczéma de dermatite atopique. Il s'agissait d'une étude interventionnel en Phase III. Son statut actuel est : terminé. L'étude a commencé le 24 février 2021, avec un objectif de recruter 683 participants. Dirigée par Arcutis Biotherapeutics, l'étude s'est terminée le 29 septembre 2022. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 octobre 2024.
Résumé succinct
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.
Titre officiel
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
Pathologies
Eczéma de dermatite atopiquePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- ARQ-151-312
Numéro NCT
Date de début (réel)
2021-02-24
Dernière mise à jour publiée
2024-10-04
Date de fin (estimée)
2022-09-29
Inscription (estimée)
683
Type d'étude
Interventionnel
PHASE
Phase III
Statut
Terminé
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalRoflumilast Cream 0.15% Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks. | Roflumilast Cream Roflumilast cream 0.15% for topical application |
Comparateur placeboVehicle Cream Participants apply vehicle cream qd for 4 weeks. | Crème véhicule Vehicle cream for topical application |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 4 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | The percentage of participants with moderate baseline scores achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from baseline in participants with a 'moderate' baseline viGA-AD score. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 4 |
vIGA-AD Success at Week 2 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 2 |
vIGA-AD Success at Week 1 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 1 |
Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 4 |
Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 2 |
Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 1 |
Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75) | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a \~75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum = of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | Week 4 |
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 4 |
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 2 |
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 1 |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
6 Years
Sexes éligibles
Tous
- Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
- Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
- In good health as judged by the Investigator.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
- Has unstable AD or any consistent requirement for high potency topical steroids.
- Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with ARQ-151.
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
Arcutis BiotherapeuticsAucune donnée de contact disponible
53 Centres de l'étude dans 2 pays
Alberta
Arcutis Clinical Site 12, Calgary, Alberta, T2G 1B1, Canada
British Columbia
Arcutis Clinical Site 09, Surrey, British Columbia, V3R 6A7, Canada
Manitoba
Arcutis Clinical Site 26, Winnipeg, Manitoba, R3M 3Z4, Canada
Ontario
Arcutis Clinical Site 20, Ajax, Ontario, L1S 7K8, Canada
Arcutis Clinical Site 23, London, Ontario, N6H 5L5, Canada
Arcutis Clinical Site 25, Toronto, Ontario, M4W 2N4, Canada
Arcutis Clinical Site 16, Waterloo, Ontario, N2J 1C4, Canada
Quebec
Arcutis Clinical Site 08, Drummondville, Quebec, J2B 5L4, Canada
Arcutis Clinical Site 27, Québec, Quebec, H3Z 2S6, Canada
Alabama
Arcutis Clinical Site 31, Birmingham, Alabama, 35244, United States
Arkansas
Arcutis Clinical Site 51, Fort Smith, Arkansas, 72916, United States
California
Arcutis Clinical Site 46, Inglewood, California, 90301, United States
Arcutis Clinical Site 19, San Diego, California, 92123, United States
Arcutis Clinical Site 36, San Diego, California, 92123, United States
Arcutis Clinical Site 13, Santa Monica, California, 90404, United States
Colorado
Arcutis Clinical Site 54, Centennial, Colorado, 80112, United States
Florida
Arcutis Clinical Site 55, Boca Raton, Florida, 33486, United States
Arcutis Clinical Site 30, Coral Gables, Florida, 33146, United States
Arcutis Clinical Site 37, Delray Beach, Florida, 33484, United States
Arcutis Clinical Site 58, Miami, Florida, 33137, United States
Arcutis Clinical Site 41, Miami, Florida, 33144, United States
Arcutis Clinical Site 11, Sanford, Florida, 32771, United States
Arcutis Clinical Site 57, West Palm Beach, Florida, 33406, United States
Idaho
Arcutis Clinical Site 62, Boise, Idaho, 83706, United States
Indiana
Clinical Site 04, Plainfield, Indiana, 46168, United States
Kentucky
Arcutis Clinical Site 43, Louisville, Kentucky, 40241, United States
Louisiana
Arcutis Clinical Site 63, Baton Rouge, Louisiana, 70808, United States
Arcutis Clinical Site 42, Lake Charles, Louisiana, 70605, United States
Arcutis Clinical Site 38, Mandeville, Louisiana, 70448, United States
Arcutis Clinical Site 06, Metairie, Louisiana, 70006, United States
Maryland
Arcutis Clinical Site 34, Rockville, Maryland, 20850, United States
Michigan
Arcutis Clinical Site 29, Clinton Township, Michigan, 48038, United States
Arcutis Clinical Site 21, Fort Gratiot, Michigan, 48059, United States
Arcutis Clinical Site 61, Troy, Michigan, 48084, United States
Missouri
Arcutis Clinical Site 245, Saint Joseph, Missouri, 64506, United States
New York
Arcutis Clinical Site 53, New York, New York, 11415, United States
Arcutis Clinical Site 39, Rochester, New York, 14623, United States
Arcutis Clinical Site 33, Stony Brook, New York, 11790, United States
North Carolina
Arcutis Clinical Site 01, High Point, North Carolina, 27262, United States
Pennsylvania
Arcutis Clinical Site 24, Hershey, Pennsylvania, 17033, United States
Arcutis Clinical Site 07, Pittsburgh, Pennsylvania, 15213, United States
South Carolina
Arcutis Clinical Site 35, Charleston, South Carolina, 29407, United States
Arcutis Clinical Site 18, Charleston, South Carolina, 29425, United States
Arcutis Clinical Site 15, North Charleston, South Carolina, 29420, United States
Texas
Clinical Site 05, Austin, Texas, 78759, United States
Arcutis Clinical Site 03, College Station, Texas, 77845, United States
Arcutis Clinical Site 59, Frisco, Texas, 75034, United States
Arcutis Clinical Site 250, Grapevine, Texas, 76051, United States
Arcutis Clinical Site 52, Pflugerville, Texas, 78660, United States
Arcutis Clinical Site 02, San Antonio, Texas, 78213, United States
Utah
Arcutis Clinical Site 32, Orem, Utah, 84058, United States
Virginia
Arcutis Clinical Site 22, Burke, Virginia, 22015, United States
Arcutis Clinical Site 17, Norfolk, Virginia, 23502, United States