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NCT06389136 · ClinicalTrials.gov registry record · Phase 3
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
A Phase 3 study of Atopic Dermatitis, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06389136 is a Phase 3 study of Atopic Dermatitis that is actively recruiting participants, run by AbbVie. The registered enrollment target is 200 participants, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT06389136, a Phase 3 study of Atopic Dermatitis, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
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 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.
Conditions Studied
Interventions
- DRUG Upadacitinib 15mg Dose
- DRUG Dupilumab 300mg Dose
- DRUG Upadacitinib 30mg Dose
Study Locations (20)
California
- Private Practice - Dr. Tooraj Raoof /ID# 263849 - Encino
- First OC Dermatology /ID# 263349 - Fountain Valley
- NorCal Medical Research /ID# 278397 - Greenbrae
- Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574 - Mission Viejo
- Dermatologist Medical Group of North County- Profound Research /ID# 266512 - Oceanside
- Stanford University School of Medicine - Redwood City /ID# 263776 - Redwood City
- Integrative Skin Science and Research /ID# 264537 - Sacramento
- West Dermatology La Jolla /ID# 265014 - San Diego
- Clinical Trials Research Institute /ID# 263846 - Thousand Oaks
Florida
- Clearlyderm Dermatology - West Boca /ID# 264923 - Boca Raton
- Skin Care Research Boca Raton /ID# 263733 - Boca Raton
- Apex Clinical Trials /ID# 263747 - Brandon
- TrueBlue Clinical Research /ID# 265037 - Brandon
- Life Clinical Trials /ID# 267195 - Coral Springs
- Revival Research - Doral /ID# 263541 - Doral
- Skin Care Research - Hollywood /ID# 263739 - Hollywood
Alabama
- Cahaba Dermatology & Skin Health Center /ID# 263855 - Birmingham
Arizona
- One Of A Kind Clinical Research Center - Scottsdale /ID# 278675 - Scottsdale
Arkansas
- Clinical Trials Institute - Northwest Arkansas /ID# 267290 - Fayetteville
Connecticut
- Yale University School of Medicine /ID# 263836 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-06-14 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06389136
The ClinicalTrials.gov registry entry for NCT06389136 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (67% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 3 interventions - of which Upadacitinib 15mg Dose is the first listed.
NCT06389136 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06389136 about?
NCT06389136 is a clinical study titled "A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab". 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...
What is the current status of trial NCT06389136?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2024-06-14. Estimated completion is 2027-03.
What conditions does trial NCT06389136 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT06389136?
The interventions under investigation include: Upadacitinib 15mg Dose (DRUG), Dupilumab 300mg Dose (DRUG), Upadacitinib 30mg Dose (DRUG).
Who is sponsoring clinical trial NCT06389136?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06389136 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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