Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  30 mg tablet daily
• Dupilumab — BIOLOGICAL
  300 mg injection every other week

Study Details

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).

Key Dates

First listed

Apr 22, 2025

Start date

Aug 2, 2021

Status verified

Aug 2026

Primary completion

Jun 30, 2026

Completion

Aug 26, 2026

Study Design

Enrollment

210 participants (actual)

Arms

• Arm: Upadacitinib (treatment group)
• Arm: Dupilumab (active comparator)

Primary Outcome Measure

POEM [ Time Frame: baseline to month 6 ]

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