A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 63 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib 15mg Dose — DRUG
  Oral tablet
• Dupilumab 300mg Dose — DRUG
  Subcutaneous (SC) injection
• Upadacitinib 30mg Dose — DRUG
  Oral tablet

Study Details

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date

Jun 14, 2024

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Period 1: Upadacitinib Open Label Treatment
  Participants randomly assigned to receive Upadacitinib 15mg tablet once per day. Based on clinical response, participants randomized to Upadacitinib 15mg may have their dose increased to Upadacitinib 30mg starting at Week 2.
• Experimental: Period 1: Dupilumab Open Label Treatment
  Participants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.
• Experimental: Period 2 Open Label: Upadacitinib < EASI 75 response
  Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will be allocated or continue to receive oral doses of Upadacitinib 30mg in Period 2 with a clinical response of \< EASI 75 at Week 8
• Experimental: Period 2 Open Label: Upadacitinib ≥ EASI 75 Response
  Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will continue to receive the same oral doses of Upadacitinib in Period 2 with a clinical response of ≥ EASI 75 at Week 8
• Experimental: Period 2 Open Label: Dupilumab ≥ EASI 75 Response
  Participants that were receiving Dupilumab 300mg and completed Period 1, will continue to receive Dupilumab 300mg SC injection in Period 2 with a clinical response of ≥ EASI 75 at Week 8
• Experimental: Period 2 Open Label Period: Dupilumab < EASI 75 Response
  Participants that were receiving Dupilumab 300mg SC injections and completed Period 1, will receive oral doses of Upadacitinib 15mg in Period 2 with a clinical response of \< EASI 75 at Week 8

Primary Outcome Measure

Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) [ Time Frame: At Week 8 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (83)

Find similar trials in Birmingham, AL

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