Efficacy and Tolerance of JAK Inhibitors in ATU for Atopi... | NCT04761978

Studies
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis

NCT04761978

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

May 22, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Dermatitis, Atopic

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Sep 1, 2022Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Feb 15, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in Eczema Area and Severity Index (EASI)		At 3 months

Secondary Outcomes

Measure	Description	Time Frame
SCORing Atopic Dermatitis (SCORAD)		at baseline and at 3 months
Investigator's Global Assessment (IGA)		at baseline and at 3 months
Dermatology Life Quality Index (DLQI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults
moderate to severe atopic dermatitis
treated by JAK inhibitors between december 2020 and september 2021
inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
ineligibility to French ongoing clinical trials

Exclusion Criteria:

Children
mild atopic dermatitis
eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
eligibility to French ongoing clinical trials
patients' opposition for the use of their records
follow up <3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients assessed by French members of the Groupe de Recherche sur l'Eczema Atopique.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Delphine Staumont-Salle, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hop Claude Huriez Chu Lille		Lisle-sur-Tarn		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided