"CRISADE-C3291037"
A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED,
VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN
INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY,
SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN
PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD
TO MODERATE ATOPIC DERMATITIS
"CRISADE-C3291037"
A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED,
VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN
INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY,
SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN
PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD
TO MODERATE ATOPIC DERMATITIS

Project number : 270201
Created by: Lena Irvhage, 2019-05-06
Last revised by: Lena Irvhage, 2019-06-04
Project created in: FoU Region Örebro län

PublishedPublished
2019-05-21
Rekrytering/datainsamling pågår

Registeranmälan

  1. "CRISADE-C3291037" A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS, Registeranmälan
  2. "CRISADE-C3291037" A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS, Projektbeskrivning

Titel och sammanfattning

Akronym

CRISADE

Populärvetenskaplig sammanfattning

Syftet med denna kliniska studie är att utvärdera säkerheten och effektiviteten för ett topiskt prövningsläkemedel i form av krisaborolsalva, 2 % vid lindrig till måttlig Atopisk Dermatit. Krisaborolsalva, 2 % är ett topiskt läkemedel  inom kategorin icke-steroida antiinflammatoriska medel som är godkänt i USA för behandling av lindrig till måttlig AD på patienter från 2 års ålder


Projektspecifik information

Ämnesord

checked Dermatologi och venerologi


(Only selected options are displayed. Click here to display all options)

Studietyp

Prövning av läkemedel

Fas

III

Randomiserad studie

Ja

Diagnoskod för huvuddiagnos

L20-L30 Dermatit och eksem

Multicenterstudie

Ja

EudraCTnr

2018-001043-31

Protokollnummer på prövningen

C3291037

Etikprövningsmyndighetens diarienummer

2019-00031

ClinicalTrials.gov

NCT03539601

Biobanksavtal

BA20/19

Inklusionsstatus

 Planerat antalAntal tillfrågadeScreen-failureAntal randominserade
n=10   

Vetenskaplig sammanfattning

Brief Summary:

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

Condition or diseaseIntervention/treatmentPhase
Atopic DermatitisDrug: Crisaborole ointment, 2%Drug: Hydrocortisone butyrate cream, 0.1%Drug: Pimecrolimus cream, 1%Drug: Crisaborole VehiclePhase 4

Detailed Description:

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged 2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects will be adults. Subjects must have mild-moderate AD involving at least 5% treatable %BSA assessed on baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD involved, excluding the scalp.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1 will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who are not eligible for TCS therapy but eligible for TCI therapy. The investigational products will be applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (End of treatment/Early termination). A follow up telephone call will be made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 36 and Day 60.

Involverade parter

Arbetsplats

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Forskning och utbildning - Kliniskt forskningscentrum workplace verified by Region Örebro län on 2018-06-14
Regioner - Region Örebro Län - Hälso- och sjukvård - Område medicin och rehabilitering - Barn - och ungdomskliniken workplace verified by Region Örebro län on 2018-06-14

Nationell koordinator

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område medicin och rehabilitering - Barn - och ungdomskliniken workplace verified by Region Örebro län on 2018-06-14

Medarbetare i projektet

Christine Degner
Studiekoordinator, USÖ Avdelningen för Kliniska Prövningar

Roll i projektet

checked Forskningssjuksköterska
Mira Ström
Studiekoordinator, Kliniskt forskningscentrum

Roll i projektet

checked Forskningssjuksköterska
Östen Jonsson
Överläkare, Barn - och ungdomskliniken

Roll i projektet

checked PI (huvudprövare eller ansvarig forskare)

Roll i projektet

checked Medarbetare

Roll i projektet

checked Forskningssjuksköterska

Roll i projektet

checked Forskningssjuksköterska

"CRISADE-C3291037"
A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED,
VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN
INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY,
SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN
PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD
TO MODERATE ATOPIC DERMATITIS, from FoU Region Örebro län
http://www.researchweb.org/is/en/fourol/project/270201