Dupilumab followed by Upadacitinib for Atopic Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atopic DermatitisUpadacitinib - Drug
Eligibility
12 - 64
All Sexes
What conditions do you have?
Select

Study Summary

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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label 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.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At week 16

At week 16
Eczema
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4
Eczema
At week 2
Eczema
Up to week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1
Eczema

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Dupilumab followed by Upadacitinib
1 of 2
Upadacitinib
1 of 2

Experimental Treatment

880 Total Participants · 2 Treatment Groups

Primary Treatment: Dupilumab followed by Upadacitinib · No Placebo Group · Phase 3

Dupilumab followed by UpadacitinibExperimental Group · 2 Interventions: Upadacitinib, Dupilumab · Intervention Types: Drug, Drug
Upadacitinib
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9090
Dupilumab
2017
Completed Phase 4
~12230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 16

Who is running the clinical trial?

AbbVieLead Sponsor
833 Previous Clinical Trials
470,229 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
303 Previous Clinical Trials
117,516 Total Patients Enrolled

Eligibility Criteria

Age 12 - 64 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have documented inadequate response to at least one prior systemic treatment for AD.
You have baseline worst pruritus numerical rating scale (WP-NRS) ≥ 4.

Who else is applying?

What state do they live in?
New York66.7%
Ontario33.3%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
Why did patients apply to this trial?
  • "I tried different drugs but didnt work,"
  • "My chronic dermatitis has plagued me for about 15 years. I have tried dozens of OTC and Rx topicals and orals with no impact on the uncomfortable symptoms."
How many prior treatments have patients received?
150.0%
3+50.0%