Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Upadacitinib; Biological: Dupilumab

• Registration Number: NCT06937788
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).

Detailed Description

Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.

Study Timeline

• Study Start: 2021-08-02
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Chronic AD with onset of symptoms at least 3 years prior to baseline
• Meets UK working party criteria
• EASI score ≥ 16
• ≥ 10% body surface area (BSA) of AD involvement at baseline ("therapy start") visit

Exclusion Criteria

• contraindications according to upadacitinib or dupilumab labeling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Upadacitinib (treatment group)	Upadacitinib	-
Dupilumab (active comparator)	Dupilumab	-

Primary Outcome Measures

Name	Time	Method
POEM	baseline to month 6	Mean POEM change

Secondary Outcome Measures

Name	Time	Method
DLQI	from baseline to month 6	Mean DLQI change
RECAP	from baseline to month 6	Mean RECAP change
EASI	from baseline to month 6	Mean EASI change
NRS Itch (past 3 days)	from baseline to month 6	Mean NRS Itch (past 3 days) change
NRS sleeping problems (past 3 days)	from baseline to month 6	Mean NRS sleeping problems (past 3 days) change
EASI 75	from baseline to month 6	EASI 75 change

Trial Locations

Locations (1)

Center for Evidence Based Health Care; 🇩🇪 Dresden, Saxony, Germany